DETAILED ACTION
Status of Application
Claims 1-29 are pending in the case.
Claims 1-29 are present for examination.
Information Disclosure Statement
The information disclosure statement filed 01/13/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Current Grounds of Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
Claims 1-2, 4-10, 12, 14, 17-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Vehige et al. (U.S. Pat. Pub. 2005/0031697).
Independent claim 1 and 9 are both directed to a composition comprising about 0.45% ketorolac and about 0.5% carboxymethyl cellulose.
Rejection:
Vehige et al. teaches an ophthalmic composition comprising a therapeutic component including ketorolac, a retention component including carboxymethylcellulose, and a carrier such as water (claim 1, 10, 12, 24, [paragraph 167-168]). The therapeutic component such as ketorolac is about 0.005-about 30%, a specific range taught is about 0.01-about 1% [164]. The retention/polyanionic component such as carboxymethylcellulose (CMC) can each be at least about 0.01%, a specific range of about 0.1-about 5% is taught [28,112], and the carboxymethylcellulose is taught to be a mixture of different molecular weights [31-33,71-72,105,113-114, claim 12 and 27-31]. The mixture can have a weight ratio of about 0.25-about 4 [113]. The specific combination of high molecular weight CMC (HCMC) and medium molecular weight CMC (MCMC) is expressly taught and exemplified (Example 1, Example 9 – Figure 2). Vehige et al. teaches the inclusion of the retention component like CMC increased retention to or on the cornea of the eye relative to ones without the retention component as it provided for increased penetration of the drug to the eye and which can facilitate enhanced delivery of the drug to the eye [7, 49, 51, 212]. Additional components for the composition include tonicity agents such as sodium chloride, buffers, acid and bases like hydrochloric acid and sodium hydroxide, and a pH of about 6 to about 8 such as a pH of about 6.8-about 8 ([169-177], Example 1, see full document specifically areas cited).
While Vehige et al. does not expressly teach the exact claimed values for the ketorolac, carboxymethylcellulose, or for the HCMC/MCMC; Vehige does teach the inclusion of each of these components with ranges that embrace the claimed values (active: about 0.01-about 1%, retention/anionic polymer(s): about 0.1-about 5%, blend of HCMC//MCM at 0.30% and 0.70% which is a ratio of 0.3:0.7 (about 1:2.33)), blends with HCMC at 0.4 and 0.45%, ratio of the two anionic polymers from about 0.25-about 4, instant claims of MCMC:HCMC is about 2).
Wherein it would be prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the taught ranges/amounts (e.g. ketorolac/active from about 0.01-1%, CMC from about 0.1-about 5%, HCMC/MCMC blend at a ratio of about 0.3:0.7 (1:2.33)) and arrive at the claimed values with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the claimed values. The claims are composition claims wherein as the structural recitations are met by the prior art. The recitation for increased bioavailability/absorption of ketorolac in the eye compared to a composition with about 0.5% ketorolac without carboxymethyl cellulose and treatment/reduction of pain/inflammation after cataract surgery with less symptoms (i.e. as compared to the composition without CMC) are to the future intended use of the composition; and as the structural components of the composition are met by the prior art, its properties and capacity for use are expected to be met as the prior art of Vehige addresses that the inclusion of a retention component like CMC increased retention to the cornea of the eye relative to ones without the retention component and provided for increased penetration of the drug to the eye and the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 3, 11, 13, 16, 19-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Vehige et al. (U.S. Pat. Pub. 2005/0031697) as applied to claims 1-2, 4-10, 12, 14, 17-18 above, in view of Cherng-Chyi et al. (U.S. Pat 5110493).
The claims are directed to ketorolac tromethamine.
Rejection:
The teachings of Vehige et al. are addressed above.
Vehige et al. does not expressly teach the incorporation of the tromethamine form of ketorolac but does expressly teach the inclusion of ketorolac for the ophthalmic composition.
Cherng-Chyi et al. teaches that a known useful ophthalmic form of ketorolac is ketorolac tromethamine (claim 3-4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate ketorolac tromethamine, as suggested by Cherng-Chyi et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because utilizing a known ophthalmic useful form of a drug such as the ketorolac form of ketorolac tromethamine is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed from of ketorolac.
The claims are composition claims and the recitation for increased bioavailability/absorption of ketorolac in the eye compared to a composition with ketorolac without carboxymethyl cellulose and treatment/reduction of pain/inflammation with less symptoms (i.e. as compared to the composition without CMC) are to the future intended use of the composition; and as the structural components of the composition are met by the prior art, its properties and capacity for use are expected to be met as the prior art of Vehige addresses that the inclusion of a retention component like CMC increased retention to the cornea of the eye relative to ones without the retention component and provided for increased penetration of the drug to the eye and the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claim 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over Vehige et al. (U.S. Pat. Pub. 2005/0031697) in view of Cherng-Chyi et al. (U.S. Pat 5110493) as applied to claims 3, 11, 13, 16,19-24 above, further in view of Rowe et al. (Sodium Citrate Dihydrate).
Dependent claim 15 is directed to the inclusion of sodium citrate dihydrate.
Rejection:
The teachings of Vehige et al. in view of Cherng-Chyi et al. are addressed above.
Vehige et al. in view of Cherng-Chyi et al. do not expressly teach the inclusion of sodium citrate dihydrate, but does expressly teach the inclusion of citric acid (Vehige et al. [179]).
Rowe et al. teaches that sodium citrate dihydrate and citric acid monohydrate (citric acid) are functional equivalents and is used in ophthalmic solutions from 0.1-2.0% (Table 1, Related Substances).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium citrate dihydrate, as suggested by Rowe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Vehige et al. teaches the inclusion of citric acid and simple substitution one known functionally equivalent citrate for another is prima facie obvious absent evidence of criticality for the specific claimed form.
Claims 25-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over Vehige et al. (U.S. Pat. Pub. 2005/0031697) in view of Cherng-Chyi et al. (U.S. Pat 5110493) and Rowe et al. (Sodium Citrate Dihydrate) as applied to claim 15 above, further in view of Si et al. (U.S. Pat. 7141607) .
The independent claim is directed to a composition comprising 0.45% ketorolac tromethamine, 0.5% carboxymethyl cellulose, 0.7% sodium chloride, 0.2% sodium citrate dihydrate and water.
Rejection:
The teachings of Vehige et al. in view of Cherng-Chyi et al. and Rowe et al. are addressed above. While Vehige in view of Cherng-Chyi and Rowe do not teach the exact claimed value for the sodium citrate dihydrate, it does teach the inclusion of sodium citrate dihydrate and its known inclusion in ophthalmic solutions from 0.1-2.0%, wherein it is prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the taught range and arrive at the claimed value with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the claimed value.
Vehige in view of Cherng-Chyi and Rowe do not expressly teach the exact claimed value for the sodium chloride, but it does teach the osmolality range to be at least about 200mOsmol, inclusion of sodium chloride as a tonicity agent (osmolality agent, Vehige [169,187]), and exemplifies its inclusion (Vehige, Example 1).
Si et al. teaches that the osmotic pressure (osmolality) of ophthalmic composition are known to be adjusted between about 40-about 400mOsm, and is achieved by adding salts such as sodium chloride in concentrations ranging between about 0.01-about 1% to the desired osmolality (Col. 7 line 33-50).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride at the claimed amount, as suggested by Si et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the as the osmolality of the composition is at least 200mOsmol and sodium chloride is expressly taught/exemplified for the composition as a tonicity agent, it is prima facie obvious to adjust the amount of sodium chloride within its conventional ranges for osmolality as addressed by Si et al. to arrive at the desired concentration/osmolality values with a reasonable expectation of success absent evidence for the claimed amount. The claims are composition claims and the recitation for treatment/reduction of pain/inflammation (i.e. from cataract surgery) is to the future intended use of the composition and as the structural components of the composition are met by the prior art; its properties and capacity for use are expected to be met as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 1-4, 6-13, 16-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bhowmick et al. (WO 2005/101982).
Rejection:
Bhowmick et al. teaches an ophthalmic composition comprising ketorolac or its salts (i.e. tromethamine) in the range from about 0.005-about 1%w/v, with cellulose derivatives including carboxymethylcellulose (CMC) in the range of about 0.01-about 5%w/v, most preferably from about 0.1-0.5% (Abstract, Page 3 line 20-Page 4 line 3, Page 4 line 13-16, claims 1-4 and 10-11 and 18-21). The composition can also include osmogents like sodium chloride; along with pH adjusters like sodium hydroxide, citric acid, hydrochloric acid, and the like to attain a pH of about 5.0-8.0 (Page 6). Example 1 teaches a composition with ketorolac tromethamine at 0.5%, sodium chloride at 0.7%, sodium hydroxide, cellulose derivative (e.g. HPMC), and water with a pH of 7.0-7.4 (embraced by about 6.8, see full document specifically areas cited).
While Bhowmick does not expressly teach the exact claimed values for the ketorolac and CMC, Bhowmick does expressly teach the combination of the ketorolac with the cellulose polymer such as CMC, and does expressly teach ranges for the ketorolac and the cellulose that embraces the claimed values (about 0.005-about 1% ketorolac, about 0.1-0.5% cellulose polymer including CMC); wherein it is prima facie obvious to optimize within the taught ranges and arrive at the claimed values with a reasonable expectation of success as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art; absent evidence of criticality for the claimed values. The recitation for increased bioavailability/absorption of ketorolac in the eye compared to a composition with about 0.5% ketorolac without carboxymethyl cellulose and treatment/reduction of pain/inflammation after cataract surgery with less symptoms (i.e. as compared to the composition without CMC) are to the future intended use of the composition; and as the structural components of the composition are met by the prior art, its properties and capacity for use are expected to be met as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 5, 14, 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bhowmick et al. (WO 2005/101982) as applied to claims 1-4, 6-13, 16-23 above, in view of AQUALON®CMC.
Rejection:
The teachings of Bhowmick et al. are addressed above.
Bhowmick et al. does not expressly teach the mixture of medium viscosity carboxymethylcellulose with high viscosity carboxymethylcellulose, but does teach the inclusion of carboxymethylcellulose and cellulose embodiments with viscosity ranges.
AQUALON® CMC teaches that there are three typical commercial viscosity types for CMC with their respective molecular weights, high viscosity-700,000 (molecular weight) which is high molecular weight CMC(HCMC), medium -250,000 (molecular weight) which is medium molecular weight CMC (MCMC), and low viscosity- 90,000(molecular weight) which is low molecular weight CMC (page 6). AQUALON® CMC also teaches that CMC is manufactured in a large range of viscosities and is the most important property of CMC solution. AQUALON® CMC teaches that any two viscosity types of CMC can be blended to yield an intermediate viscosity (Page 13-14). A blending chart and equation are available from AQUALON® to determine the amounts of two known viscosity types of CMC to achieve the desired viscosity with an example ratio of about 30wt.% of Material A (higher weight polymer) and about 70wt.% of Material B (lower weight polymer, Figure 9).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to blend known viscosity types of CMC such as high molecular weight and medium molecular weight CMC, as suggested by AQUALON® CMC, and produce the instant invention; as AQUALON® CMC addresses that it is known and prima facie obvious to utilize blends of commercially available CMC to obtain a desired intermediate viscosity with a reasonable expectation of success with the equation and blending charts such as the depicted values of about 30% for the higher weight polymer (i.e. embraces the 0.35% of the claimed high viscosity CMC, 0.35% HCMC of 0.5% total CMC=0.175%) and about 70% for the lower weight polymer (embraces the 0.65% of the claimed medium viscosity CMC, 0.65% MCMC of 0.5% total CMC=0.325%), and to optimize around those values to obtain a desired viscosity (a means of modifying the viscosity, e.g. adjusting their fluidity as they are related to the viscosity of the composition and impacts on the desired profile of medicinal delivery) absent evidence of criticality for the claimed values.
Claims 15, 25-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bhowmick et al. (WO 2005/101982) in view of AQUALON®CMC as applied to claims 5, 14, 24 above, in view of Rowe et al. (Sodium Citrate Dihydrate).
Rejection:
The teachings of Bhowmick in view of AQUALON®CMC are addressed above.
Bhowmick in view of AQUALON®CMC do not expressly teach the inclusion of sodium citrate dihydrate, but does expressly teach the inclusion of citric acid (Bhowmick Page 6).
Rowe et al. teaches that sodium citrate dihydrate and citric acid monohydrate (citric acid) are functional equivalents and is used in ophthalmic solutions from 0.1-2.0% (Table 1, Related Substances).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium citrate dihydrate, as suggested by Rowe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this as simple substitution of one known functionally equivalent citrate for another is prima facie obvious absent evidence of criticality for the specific claimed form. The claims are composition claims and the recitation for treatment/reduction of pain/inflammation (i.e. from cataract surgery) is to the future intended use of the composition and as the structural components of the composition are met by the prior art; its properties and capacity for use are expected to be met as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 1-4,6-13,16-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ousler, III et al. (U.S. Pat. Pub. 2007/0254841).
Rejection:
Ousler, III et al. teaches a composition for treating dry eye and increasing tear film break up time comprising a NSAID and a tear substitute (Abstract, [paragraph 4]). The composition can be administered with 1-2 drop of the solution to the affected eye [35]. Signs and symptoms of dry eye include blurry vision and decreased tear film break up time [2] wherein treatment of dry eye intrinsically improves these symptoms.
The NSAIDS include ketorolac tromethamine (claimed, exemplified) and the effective amount for ketorolac is from about 0.05 to about 0.5% ([23-24], claim 1, 3-5, 12, 14). The examples used Acular® which contains ketorolac tromethamine (drug 0.5%), sodium chloride (tonicity agent), purified water (carrier), and hydrochloric acid and/or sodium hydroxide (pH adjusters, evidenced by Allergan® insert from www.Drugs.com).
The tear substitutes are known in the art and include polymers like carboxymethylcellulose [26] and Refresh® artificial tears (claimed, exemplified ([28], claim 8) which is known to contain carboxymethylcellulose sodium at 0.5% in purified water (5mg/ml, as evidenced by the REFRESH TEARS Lubricating Eye Drops package insert, by South African Electronic Package Inserts).
The example of Ousler combines the Acular® and the Refresh tears together to form the composition (has ketorolac tromethamine, carboxymethylcellulose, sodium chloride, hydrochloric acid and/or sodium hydroxide, and purified water).
The composition can comprise conventional buffers, pH adjusters, and tonicity agents such as sodium chloride, citric acid, potassium citrate [37-39], and hydrochloric acid and/or sodium hydroxide (Acular® [63]). The amount of buffer is from about 0.05-2.5%, osmolality is from about 225-400mOsm/kg, and the pH is more preferably from about 6.5-7.8 [38-39].
While Ousler et al. does not expressly exemplify the ketorolac tromethamine at about 0.45%, Ousler does expressly teach that the effective amount for ketorolac is from about 0.05 to about 0.5%, wherein it embraces the claimed value and would be prima facie obvious to optimize within the taught range and arrive at the claimed value with a reasonable expectation of success as a means of attaining the desired therapeutic profile absent evidence of criticality for the claimed amount. The recitation for increased bioavailability/absorption of ketorolac in the eye compared to a composition with about 0.5% ketorolac without carboxymethyl cellulose and treatment/reduction of pain/inflammation after cataract surgery with less symptoms (i.e. as compared to the composition without CMC) are to the future intended use of the composition; and as the structural components of the composition are met by the prior art, its properties and capacity for use are expected to be met as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 5, 14, 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ousler, III et al. (U.S. Pat. Pub. 2007/0254841) as applied to claims 1-4, 6-13, 16-23 above, in view of Chang et al. (U.S. Pat. 7045121).
Rejection:
The teachings of Ousler et al. are addressed above.
Ousler et al. does not expressly teach the incorporation of a mixture of MCMC with HCMC, but does teach the inclusion of CMC.
Chang et al. teaches that a mixture of different molecular weights of the polyanionic component such as HCMC and MCMC, provides better lubrication to the eye and useful for dry eye, including HCMC at 0.35% and MCMC at 0.65% (Col. 1 line 50-Col. 2 line 13, Examples 1-4).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate a mixture of HCMC with MCMC, as suggested by Chang, and produce the instant invention as it is prima facie obvious to incorporate a mixture of the HCMC and MCMC such as the demonstrated mixture of 0.35% HCMC and 0.65% MCMC as it improves lubrication for dry eye, with the composition of Ousler with CMC which is also for dry eye (0.35% of 0.5% CMC is 0.175% HCMC), each of which is taught by prior art to be useful for same purpose (dry eye) with a reasonable expectation of success as it is desirable to have and produce a composition comprising many components which have desirable effects for treating the dry eye condition resulting in their combined effect.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ousler, III et al. (U.S. Pat. Pub. 2007/0254841) as applied to claims 1-4, 6-13, 16-23 above, in view of Harting et al. (U.S. Pat. 4522829).
Rejection:
The teachings of Ousler et al. are addressed above.
Ousler et al. does not expressly teach the incorporation of sodium citrate dihydrate (sodium citrate), but does teach the inclusion of buffers such as citric acid and its salts like potassium citrate for the solution from about 0.05-2.5%.
Harting et al. teaches that sodium borate, boric acid, trisodium citrate (also known as sodium citrate dihydrate) are all known functionally equivalent ophthalmic buffers (Col. 3 line3-7).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate trisodium citrate, as suggested by Harting, and produce the instant invention with a reasonable expectation of success; as simple substitution of one known buffer for another is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed buffer. It would also be obvious to optimize the amount of buffer within the taught range to arrive at the claimed value as a means of attaining the desired profile and pH with a reasonable expectation of success; absent evidence of criticality for the exact amount recited.
Claims 25-26, 28-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ousler, III et al. (U.S. Pat. Pub. 2007/0254841) in view of Harting et al. (U.S. Pat. 4522829) as applied to claims 15 above, further in view of Si et al. (U.S. Pat. 7141607).
The independent claim is directed to a composition comprising 0.45% ketorolac tromethamine, 0.5% carboxymethyl cellulose, 0.7% sodium chloride, 0.2% sodium citrate dihydrate and water.
Rejection:
The teachings of Ousler in view of Harting are addressed above.
While Ousler in view of Harting does not expressly teach the exact claimed values for the sodium chloride, but it does teach the osmolality range to be from about 225-400mOsm and the inclusion of sodium chloride as a tonicity/osmolality agent (Ousler [39]), and exemplifies its inclusion (Ousler, Example 1).
Si et al. teaches that the osmotic pressure (osmolality) of ophthalmic composition are known to be adjusted between about 40-about 400mOsm, and is achieved by adding salts such as sodium chloride in concentrations ranging between about 0.01-about 1% to the desired osmolality (Col. 7 line 33-50).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride at the claimed amount, as suggested by Si et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the osmolality of the composition is taught be from about 225-400mOsm and sodium chloride is expressly taught/exemplified for the composition as a tonicity/osmolality agent, wherein it is prima facie obvious to adjust the amount of sodium chloride within its conventional ranges for osmolality as addressed by Si et al. to arrive at the desired concentration/osmolality values with a reasonable expectation of success absent evidence for the claimed amount. The recitation for increased bioavailability/absorption of ketorolac in the eye compared to a composition with about 0.5% ketorolac without carboxymethyl cellulose and treatment/reduction of pain/inflammation after cataract surgery with less symptoms (i.e. as compared to the composition without CMC) are to the future intended use of the composition; and as the structural components of the composition are met by the prior art, its properties and capacity for use are expected to be met as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ousler, III et al. (U.S. Pat. Pub. 2007/0254841) in view of Harting et al. (U.S. Pat. 4522829) and Si et al. (U.S. Pat. 7141607 as applied to claims 25-26, 28-29 above, further in view of Chang et al. (U.S. Pat. 7045121).
Rejection:
The teachings of Ousler in view of Harting and Si are addressed above.
Ousler et al. in view of Harting and Si does not expressly teach the incorporation of a mixture of MCMC with HCMC, but does teach the inclusion of CMC.
Chang et al. teaches that a mixture of different molecular weights of the polyanionic component such as HCMC and MCMC, provides better lubrication to the eye and useful for dry eye, including HCMC at 0.35% and MCMC at 0.65% (Col. 1 line 50-Col. 2 line 13, Examples 1-4).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate a mixture of HCMC with MCMC, as suggested by Chang, and produce the instant invention as it is prima facie obvious to incorporate a mixture of the HCMC and MCMC such as the demonstrated mixture of 0.35% HCMC and 0.65% MCMC as it improves lubrication for dry eye, with the composition comprising CMC which is also for dry eye (0.35% of 0.5% CMC is 0.175% HCMC), each of which is taught by prior art to be useful for same purpose (dry eye) with a reasonable expectation of success as it is desirable to have and produce a composition comprising many components which have desirable effects for treating the dry eye condition resulting in their combined effect.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 7842714.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims recite a composition comprising the same components as the instant claims with the same or similar values. The patented claims meet the instant composition’s structural recitations wherein it would be expected to have the desired results and properties are met such as bioavailability of the ketorolac or the capacity for its intended use as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 1-2, 4-10,12,14,17-18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8512717.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims are directed to a composition with the same components as recited in the instant claims, and while it does not expressly recited the exact same values as the instant claims, they are embraced; wherein it is prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the claimed ranges/ratios and arrive at the instant values with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the instant values. The patented claims meet the instant composition’s structural recitations wherein it would be expected to have the desired results and properties are met such as bioavailability of the ketorolac or the capacity for its intended use as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 3,11,13,16,19-22,24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8512717 as applied to claims 1-2, 4-10,12,14,17-18 above, in view of Cherng-Chyi et al. (U.S. Pat 5110493).
The teachings of the patented claims are addressed above.
The patented claims do not expressly teach the incorporation of the tromethamine form of ketorolac but does expressly claim the inclusion of ketorolac for the ophthalmic composition.
Cherng-Chyi et al. teaches that a known useful ophthalmic form of ketorolac is ketorolac tromethamine (claim 3-4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate ketorolac tromethamine, as suggested by Cherng-Chyi et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because utilizing a known ophthalmic useful form of a drug such as the ketorolac form of ketorolac tromethamine is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed from of ketorolac.
Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8512717 in view of Cherng-Chyi et al. (U.S. Pat 5110493) as applied to claims 3,11,13,16,19-22,24 above, further in view of Rowe et al. (Sodium Citrate Dihydrate).
The teachings of the patented claims in view of Cherng-Chyi et al. are addressed above.
The patented claims in view of Cherng-Chyi et al. do not expressly teach the incorporation of sodium citrate dihydrate, but does expressly teach the inclusion of a buffer.
Rowe et al. teaches that sodium citrate dihydrate is a known excipient with various uses including as a buffer, and is used in ophthalmic solutions from 0.1-2.0% (Table 1, Related Substances).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate a known buffer such as sodium citrate dihydrate, as suggested by Rowe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because incorporation of a known ophthalmic excipient to perform its known function (buffer) is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specific instant component.
Claims 25-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8512717 in view of Cherng-Chyi et al. (U.S. Pat 5110493) and Rowe et al. (Sodium Citrate Dihydrate) as applied to claim 15 above, further in view of Si et al. (U.S. Pat. 7141607).
The teachings of the patented claims in view of Cherng-Chyi et al. and Rowe et al. are addressed above.
The patented claims in view of Cherng-Chyi et al. and Rowe et al. do not expressly teach the exact claimed values for the sodium chloride, but it does teach the inclusion of sodium chloride for the composition.
Si et al. teaches that the osmotic pressure (osmolality) of ophthalmic compositions are known to be adjusted between about 40-about 400mOsm, and is achieved by adding salts such as sodium chloride in concentrations ranging between about 0.01-about 1% to the desired osmolality (Col. 7 line 33-50).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride at the instant amount, as suggested by Si et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the patented claims recite the inclusion of sodium chloride for the ophthalmic composition and it is prima facie obvious to adjust the amount of sodium chloride within its conventional ranges for osmolality as addressed by Si et al. to arrive at the desired concentration/osmolality values with a reasonable expectation of success absent evidence for the instant amount.
Claims 1-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9192571.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims are directed to a composition with the same components as recited in the instant claims (i.e. 0.45% ketorolac, 0.5% carboxymethylcellulose). The values are either the same or similar, wherein in those particular claims that do not recite the exact same values as the instant claims, they are embraced; wherein it is prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the claimed ranges and arrive at the instant values with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the instant values. The patented claims meet the instant composition’s structural recitations wherein it would be expected to have the desired results and properties are met such as bioavailability of the ketorolac or the capacity for its intended use as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claims 1-14, 16-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8992952.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims are directed to a composition with the same components as recited in the instant claims (i.e. ketorolac and its tromethamine salt, carboxymethylcellulose (mixture off medium and high molecular weight)). The values embrace the instant claims; wherein it is prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the claimed ranges/ratios and arrive at the instant values with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the instant values. The patented claims meet the instant composition’s structural recitations wherein it would be expected to have the desired results and properties are met such as bioavailability of the ketorolac or the capacity for its intended use as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
Claim 15 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8992952 as applied to claims 1-14, 16-24 above, in view of Rowe et al. (Sodium Citrate Dihydrate).
The teachings of the patented claims are addressed above.
The patented claims do not expressly teach the incorporation of sodium citrate dihydrate, but does expressly teach the inclusion of a buffer.
Rowe et al. teaches that sodium citrate dihydrate is a known excipient with various uses including as a buffer, and is used in ophthalmic solutions from 0.1-2.0% (Table 1, Related Substances).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate a known buffer such as sodium citrate dihydrate, as suggested by Rowe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because incorporation of a known ophthalmic excipient to perform its known function (buffer) is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specific instant component.
Claims 25-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8992952 in view of Rowe et al. (Sodium Citrate Dihydrate) as applied to claim 15 above, further in view of Si et al. (U.S. Pat. 7141607).
The teachings of the patented claims in view of Rowe et al. are addressed above.
The patented claims in view of Rowe et al. do not expressly teach the exact claimed values for the sodium chloride, but it does teach the inclusion of sodium chloride for the composition.
Si et al. teaches that the osmotic pressure (osmolality) of ophthalmic compositions are known to be adjusted between about 40-about 400mOsm, and is achieved by adding salts such as sodium chloride in concentrations ranging between about 0.01-about 1% to the desired osmolality (Col. 7 line 33-50).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride at the instant amount, as suggested by Si et al., and produce the instant invention; as it is prima facie obvious to adjust the amount of sodium chloride within its conventional ranges for osmolality as addressed by Si et al. to arrive at the desired concentration/osmolality values with a reasonable expectation of success absent evidence for the instant amount.
Claims 1-3, 5-14, 16-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6, 14 of copending Application No. 19/197402.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the copending claims are directed to a composition with the same components as recited in the instant claims. The values are either the same or similar (0.45 ketorolac tromethamine, 0.5% CMC, 0.2-2% CMC, mixture of MCMC/HCMC with CMC at 0.5%), wherein in the particular claims that do not recite the exact same values as the instant claims, they are embraced (i.e. mixture of MCMC/HCMC with CMC at 0.5%, MCMC/HCMC at 0.325%/0.175%=0.5%) wherein it is prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize within the claimed ranges and arrive at the instant values with a reasonable expectation of success; as it is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art, absent evidence of criticality for the instant values. The copending claims meet the instant composition’s structural recitations wherein it would be expected to have the desired results and properties are met such as bioavailability of the ketorolac or the capacity for its intended use as the instant disclosure addresses that the composition with the claimed components (i.e. CMC) would perform in in this manner.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 4, 15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6, 14 of copending Application No. No. 19/197402 as applied to claims 1-3, 5-14, 16-24 above, in view of Rowe et al. (Sodium Citrate Dihydrate).
The teachings of the copending claims are addressed above.
The copending claims do not expressly teach the incorporation of sodium citrate dihydrate but is directed to an ophthalmic solution.
Rowe et al. teaches that sodium citrate dihydrate is a known excipient with various uses including as a buffer, and is used in ophthalmic solutions from 0.1-2.0% (Table 1, Related Substances).
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate a known buffer such as sodium citrate dihydrate, as suggested by Rowe et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because incorporation of a known ophthalmic excipient to perform its known function (buffer) is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the specific instant component.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 25-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6, 14 of copending Application No. No. 19/197402 in view of Rowe et al. (Sodium Citrate Dihydrate) as applied to claims 4 and 15 above, further in view of Si et al. (U.S. Pat. 7141607).
The teachings of the copending claims in view of Rowe et al. are addressed above, including the incorporation of a known buffer such as sodium citrate dihydrate; wherein it would be prima facie obvious to optimize within the conventional range as a means to attain the desired buffering level and arrive at the claimed values with a reasonable expectation of success absent evidence of criticality for the claimed values.
The copending claims in view of Rowe et al. do not expressly teach the inclusion of sodium chloride, but is directed to an ophthalmic solution.
Si et al. teaches that the osmotic pressure (osmolality) of ophthalmic compositions are known to be adjusted between about 40-about 400mOsm, and is achieved by adding salts such as sodium chloride in concentrations ranging between about 0.01-about 1% to the desired osmolality (Col. 7 line 33-50).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride at the instant amount, as suggested by Si et al., and produce the instant invention.
It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to incorporate sodium chloride as an tonicity agent at the claimed amount, as suggested by Si et al. and produce the instant invention; as it is prima facie obvious to incorporate known conventional excipients for their known purpose within its conventional ranges for osmolality and arrive at the desired concentration/osmolality values with a reasonable expectation of success absent evidence for the claimed amount.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Claims 1-29 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613