DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn rejections
Rejection of claims 124 and 125 under 35 USC 112(b) is withdrawn in view of amendments to the claims filed on 3/23/26.
Rejection of claims 114-120 and 124-129 under 35 USC 103 over Moutet et al is withdrawn in view of amendments filed on 3/23/26
Rejections on the ground of nonstatutory double patenting over US 11,931,336 and application 18/205,305 are withdrawn in view of amendments and terminal disclaimer filed on 3/23/26.
Election/Restrictions
Newly submitted claims 139, 140, 141, 146, 150 and 154 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The claims are directed to a composition comprising urolithin and ubiquinol, ubiquinone or niacin. The additional components are materially different from the components that have been considered in the non-final rejection mailed on 9/23/25.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 139, 140, 141, 146, 150 and 154 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
New rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 121, 123, 125, 132, 138, 143, 145, 147, 149, 151-153 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and further in view of Ndiaye et al (Arch Biochem Biophys 2011, 508(2) 164-170).
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach administration of a combination of Urolithin A and Resveratrol
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Ndiaye teaches that they have shown that topical application of resveratrol results in inhibition of inflammation (page 4, last paragraph).
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and resveratrol to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties and are therefore equivalents with regards to reduction of inflammation. Since it is obvious to use either agent in treatment of skin infmamation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)
Claim 122, 131, 137, 144, 148 and 152 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and further in view of Nolan et al (Journal of Drugs in Dermatology, 2012, 11(2), 220-224).
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach administration of a combination of Urolithin A and Vitamin C
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Nolan teaches Vitamin C has been shown to have anti-inflammatory function on the skin (page 221, section “ascorbic acid”)
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and vitamin C to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties and are therefore equivalents with regards to reduction of inflammation. Since it is obvious to use either agent in treatment of skin inflammation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Claim 130 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and in further view of Choi et al (Journal of Biomedical Science, 2012, 19:31)
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach combination of Urolithin A and spermidine
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Choi teaches anti-inflammatory effects of spermidine (page 7, conclusion)
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and Spermidine to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties and are therefore equivalents with regards to reduction of inflammation. Since it is obvious to use either agent in treatment of skin inflammation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Claim 133 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and in further view of Giampero (US 7291625)
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach combination of Urolithin A and riboflavin
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Giampero teaches a formulation comprising riboflavin in treatment of inflammation. (Column 1, lines 15-29).
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and the combination of riboflavin and niacin (as suggested by Giampero) to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties and are therefore equivalents with regards to reduction of inflammation. Since it is obvious to use either agent in treatment of skin inflammation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Claim 134 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and in further view of Gad (Journal of advanced research, 2010, 1, 169-177),
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach combination of Urolithin A and L-arginine
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Gad teaches L-arginine as an agent with anti-inflammatory properties (page 173, column 1, lines 6-8)
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and L-arginine to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties. Since it is obvious to use either agent in treatment of inflammation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Claim 135 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and in further view of Nivaggioli et al (US 20090105196)
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach combination of Urolithin A and creatine.
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Nivaggioli teaches use of creatine in treatment of dermatitis and suggests combination with another anti-inflammatory agent (paragraph [0015])
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to obvious to try co-administer urolithin A and creatine to a subject in need of treatment of skin inflammation. Nivaggiolii suggests combination of creatine and an anti-inflammatory agent for treatment of dermatitis. In view of the teaching, it would have been obvious to combine creatine with Urolithin A, which is described as having anti-inflammatory properties.
Claim 136 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonzalez-Sarrias et al (Gonzalez) (British Journal of Nutrition 2010, 104, 503-512) in view of Friedman et al (J Cutan Med Surg 2002, 6(5):449-59) and in further view of Chittur et al (Evidence based Complimentary and Alternative medicine, 2011, 1-7)
Scope of prior art
Gonzalez teaches that urolithins are ellagic acid derived metabolites, which is present in the pomegranate extract (Abstract). While previous studies have reported anti-inflammatory properties of pomegranate extracts, Gonzalez was able to demonstrate that the anti-inflammatory properties are can be attributed to urolithins and to the ellagic acid. On page 510, column 2, 2nd full paragraph, Gonzalez teaches that Urolithin A achieves anti-inflammatory effect through decreased production of PGE2 by downregulating COX2 and mPGES-1 expression. From the teaching of Gonzalez it is clear that urolithin, especially urolithin A is an anti-inflammatory agent.
Ascertaining the difference
While Gonzalez teaches anti-inflammatory activity of Urolithins A and B, Gonzalez does not teach a method of treating skin inflammation by administering to a subject a composition comprising urolithin.
Gonzalez does not teach combination of Urolithin A and carnitine
Secondary reference
Friedman teaches nonsteroidal anti-inflammatory drugs (NSAID) serve an important role in dermatology because inflammation is a common component of many skin diseases. The inti-inflammatory function is facilitated by the ability of NSAISs to disrupt the production of prostaglandins by inhibiting COX enzymes (page 449, paragraph 1). Friedman also teaches various methods of administration of NSAIDs in treatment of various skin diseases, including topical application resulting in suppressing prostaglandin production (page 450, column 2, paragraph 4).
Chittur teaches carnitine as an anti-inflammatory agent spermidine (abstract, line 4))
Obviousness
A person of ordinary skill in the arts would have found it obvious to try treating skin inflammation in a subject in need thereof by administrating to the subject an effective amount of Urolithin A. Treatment of skin inflammation by topical administration of a NSAIDs is taught by Friedman. Friedman teaches that treatment of inflammation by NSAIDs takes place by inhibiting production of prostaglandins through inhibition of COX2 and also teaches on page 450 that topical administration of a NSAID resulted in inhibition of PG production. At issue is whether it would have been obvious to use Urolithin A as a NSAID in treatment of skin inflammation instead of one of the agents described by Friedman. Gonzalez teaches that Urolithin A has anti-inflammatory activity which is achieved by decrease of PGE2 expression through inhibition COX2. The mechanism of action described by Gonzalez is the same as the one described by Friedman. Since Urolithin A is not a steroid, it can effectively be classified as a NSAID. A person of ordinary skill would have found it obvious to try treating skin inflammation by administering to a subject Urolithin A because its activity is in line with other anti-inflammatory agents used for the same purpose. A POSA would have also found it obvious to try topical application to the affected area of the skin because a topical application (as opposed to systemic) provides a more targeted administration. There is a reasonable expectation of success because Gonzalez teaches Urolithin A as having the desired anti-inflammatory activity.
A person of ordinary skill in the arts would have found it obvious to try to co-administer urolithin A and carnitine to a subject in need of treatment of skin inflammation. Both agents are described in the arts as having anti-inflammatory properties. Since it is obvious to use either agent in treatment of inflammation, there is expectation that the combination of the two can also be successfully used for treatment of skin inflammation.
MPEP 2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Conclusion
Claims 121-123, 125, 130-154 are pending
Claims 139, 140, 141, 146, 150 and 154 are withdrawn
Claims 121-123, 125, 130-138, 142-145, 147-149 and 151-153 are rejected
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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