DETAILED ACTION
Status of Application
The response filed 02/17/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claim 19 has been amended.
Applicant had previously elected Group II in response to restriction requirement and for the examination.
Due to restriction, based on election of Group II, claims 1-9 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
It is noted to Applicant that claim 3 has the wrong claim identifier – it should be listed as withdrawn – being directed to the non-elected invention.
Claims 1-19 are pending.
Claims 10-19 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
Applicant objects to the references that were not considered on the IDS filed 04/22/2025 as it fails to provide an English translation for the references to be considered. Applicant’s arguments centers on the argument that an English translation is not available and that the NPL documents are cited on the Office action by the Federal Service for Intellectual Property in Russian Patent Application No 2023105229 which has an English translation, as the Examiner will consider the information in view of the concise explanation and insofar as understood on its face e.g. drawings, chemical formula, in the same manner that non-English language information in Office search files is considered by examiner in conducting searches. The examiner need not have the information translated unless it appears to be necessary to do so.
The IDS fails to state on its face what office action was referenced and the office action does not provide an abstract, drawings, or chemical formula to be understood on its face. It is reconsidered as cited on the IDS only as far the limited recitation in the English translation of the Office action by the Federal Service for Intellectual Property in Russian Patent Application No 2023105229.
Standing Grounds of Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-15, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kambe et al. (U.S. Pat. Pub. 2012/0122964) in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
Rejection:
Kambe et al. teaches treating glaucoma/ocular hypertension with a compound of formula I including compound 16(25)
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(also known as sepetaprost, ONO-9054 and DE-126, [209]). Kambe et al. teaches that the active can be applied by eyedrops [119] and at a more preferred concentration of 0.00001-0.05%w/v ([120], abstract, claims 11-13). Example 16(25) (sepetaprost) was exemplified and administered by eyedrop at a concentration of 10µg/ml (0.001%w/v) to lower intraocular pressure and was the most effective of the actives tested and was also more effective than Latanoprost (lowering rate of 40.6% verses latanoprost at 25.4%, Table 8 [750-753]); as the treatment of glaucoma with prostaglandins and their derivatives are known the existing glaucoma treatment drug alone is insufficient or have manifestations of side effects that is feared; where drug with stronger and sustaining intraocular pressure lowering action and high safety is desired [3]; and the invention has a strong and sustained lowering action of on intraocular pressure, is useful for glaucoma having no side effect on the eyes (like hyperemia) ([22], see full document specifically areas cited).
Kambe et al. does not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost but does teach treating glaucoma/ocular hypertension with Example 16(25) (sepetaprost) and that sepetaprost was more effective than latanoprost (a prostaglandin), and that prostaglandins for the treatment of glaucoma is known and the existing glaucoma treatment with the drug alone is insufficient or have manifestations of side effects that is feared where a drug with stronger and sustaining intraocular pressure lowering action and high safety is desired – and the compounds of Kambe et al. like sepetaprost are useful for glaucoma having no side effect on the eyes (like hyperemia)
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a and more than 30% of glaucoma patients on PGA treatment will need additional medical treatment a few years down the line, but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (Example 16(25)) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) and more than 30% of glaucoma patients on PGA treatment will need additional medical treatment a few years down the line (where the treatment stops working), wherein other treatments like the drugs presented including sepetaprost which is a promising agent - would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment like ONO-9054/sepetaprost as expressly directed by Matsou with a reasonable expectation of success and Kambe et al supports the teaching that sepetaprost (Example 16(25) is useful in the treatment of glaucoma and is more effective than latanoprost - as an eyedrop with therapeutic concentrations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are centered on the assertion that Matsou does not teach each limitation claimed, that Kambe does not teach each limitation claimed, the assertion of unexpected results, and the assertion that one would not have been motivated to administer ONO-9054/sepetaprost as taught by Kambe or Matsou as they teach away from the use of sepetaprost.
This has been fully considered but not persuasive.
Applicant’s argument that neither Matsou nor Kambe singularly teach each limitation claimed such as administration of ONO-9054/sepetaprost to a patient for whom other therapeutic agents for glaucoma/ocular hypertension is inadequately effective (refractory) is to the reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The assertion that a single reference should contain all the claimed elements and have a singular teaching to be applicable for obviousness which is not the standard for obviousness. Obviousness is not restricted to a single working example or to a single reference as obviousness may be to a combination of references as addressed in the rejection above.
As for the assertion of unexpected results, this is not persuasive. The example in the specification is not a showing of unexpected results but rather a showing of expected improvement in glaucoma/ocular hypertension with the treatment of 0.002%w/v with one drop (20uL/eye) - as it is showing the reduction of intraocular pressure that is expected as taught by Kambe and Matsou. Kambe establishes that the sepetaprost (ONO-9054) is effective in lowering the intraocular pressure (IOP)and was the most effective of the actives tested (40% reduction). Matsou addressed that sepetaprost had strong and long lasting hypotensive effect with favorable safety profiles such as marked reductions in IOP across all treatment groups proportionate with dose concentrations like -7mmHg following single dosing, and had the potential to have a more robust reduction of IOP thanks to the dual stimulation of receptors and that it had a more potent and sustainable IOP lowering effect than two PGAs. Additionally, the example of the specification is not commensurate in scope with the claims as written – the example is to treatment of glaucoma/ocular hypertension with a drop of 0.002%w/v with sepetaprost (20uL/eye) to monkeys with an inadequate response to latanoprost, while the breath claimed is substantially broader to any active and with no dosing or concentration recited commensurate with the example.
As for assertion that Kambe and Matsou teach away from the use of sepetaprost, this is not persuasive. The assertion that Kambe does not teach giving sepetaprost to a patent not responsive to another glaucoma active such as in the dog testing, is again to the reference individually and not the combination of references as addressed above. Applicant also asserts that Kambe teaches that sepetaprost was more effective than latanoprost so that one of ordinary skill in the art would be motivated to substitute latanoprost with sepetaprost and not motivated to use sepetaprost to a patient after latanoprost had been found inadequate for the treatment is not persuasive. Kambe teaches that sepetaprost is effective in lowering the intraocular pressure and was the most effective of the actives tested and more effective than latanoprost, which establishes sepetaprost to be an effective glaucoma treatment wherein it can be useful in various ways and as Matsou et al. established that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy which is the first line treatment (implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) and more than 30% of glaucoma patients on PGA treatment will need additional medical treatment a few years down the line (where the treatment stops working); Matsou expresses and highlights the need for more potent, more efficacious and more tolerable drugs to existing therapies and presents the most promising treatments including sepetaprost with its dual action with favorable safety profile; wherein it is prima facie obvious to utilize the new treatment like sepetaprost for those who do not respond to conventional prostaglandins and those on who need medical treatment after being on PGA treatment for a few years (where it no longer is effective/refractory) with a reasonable expectation of success. As it is conventional medical practice to use a known first line treatment (i.e. prostaglandins) and then use a new/different treatment for the condition when the one being used is not effective or no longer effective in order to find a treatment that is useful for the condition – as one does not forgo treatment when there are available actives (i.e. doctors give a known conventional treatment and if not successful or no longer effective, give a new/different drug treatment in order to treat the condition as one does not leave the patient untreated). The assertion that Matsou et al. teaches away from using sepetaprost as prostaglandins and sepetaprost have completely different chemical structures and mechanisms of action is not persuasive as Matsou et al. establishes sepetaprost to be one of the promising agents for glaucoma as it has a more potent and sustainable effect on intraocular pressure because of its dual mechanism of action wherein its use for glaucoma including the patients that Matsou addresses as being in need of treatment that are not responding to conventional prostaglandin treatment and those who will need additional therapy (refractory) is prima facie obvious with a reasonable expectation of success. As for the assertion that Matsou only addresses omidenepag isopropyl for patients that were non/low responders to latanoprost where one would not be motivated to substitute sepetaprost for omidenepag isopropyl is fully considered but not persuasive as Matsou addresses that omidenepag isopropyl was compared to latanoprost in various trials and then investigated in non/low responders to latanoprost which demonstrates the expected progression in use for glaucoma actives; and Matsou establishes sepetaprost to be one of the promising agents for glaucoma it is prima facie obvious to use it for the glaucoma patients that may not respond to prostaglandins or those on PGA treatment that will need additional treatment later as described by Matsou with a reasonable expectation of success.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, the rejection stands.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kambe et al. (U.S. Pat. Pub. 2012/0122964) in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-15, 17-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
Rejection:
The teachings of Kambe et al. in view of Matsou et al. are addressed above.
Kambe et al. in view of Matsou et al. does not expressly recite the exact claimed value of 0.002%w/v for sepetaprost (Example 16(25) but does teach the compound to be in a concentration of 0.00001-0.05%w/v and was exemplified at a concentration of 10µg/ml (0.001%w/v).
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed at various concentrations including 10µg/ml and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations as suggested by Suto et al. and produce the claimed invention; as Kambe et al. teaches it to be in a concentration of 0.00001-0.05%w/v and exemplified it at a concentration of 10µg/ml wherein utilizing a known concentration that is within the taught range as a means of optimizing the drug to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to Kambe et al. in view of Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto as not teaching administering sepetaprost as an active ingredient to a patient for whom other therapeutic agent for glaucoma/ocular hypertension is inadequately effective. This is fully considered but not persuasive as it is to Suto reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Suto is presented merely to demonstrate the known concentration for sepetaprost for lowering intraocular pressure and utilizing a known concentration that is within the taught range as a means of optimizing the drug to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success.
Accordingly, the rejection stands.
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 10-13, 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 of U.S. Patent No. 12201602 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
The patented claims are directed to the method of treating glaucoma/ocular hypertension with the simultaneous or concomitant administration of sepetaprost and at least one of netarsudil or a salt thereof.
The patented claims do not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost (in combination with netarsudil and/or its salt) but does claim treating glaucoma/ocular hypertension with sepetaprost (in combination with netarsudil and/or its salt).
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (along with its combination treatment with netarsudil) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) wherein other treatments like sepetaprost would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment as directed by Matsou with a reasonable expectation of success as the patented claims teaches that sepetaprost and its combination treatment is useful in the treatment of glaucoma with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments center on the assertions that Matsou does not teach the instant claims, that the recited claims do not teach the instant claims, the assertion of unexpected results, that Matsou teaches away from the instant claims, and hindsight.
This is fully considered but not persuasive.
The assertion that neither the recited claims nor Matsou teach the instant claims is to the Matsou reference and the recited claims individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The assertion of unexpected results as addressed above, is not persuasive. The example in the specification is not a showing of unexpected results but rather a showing of expected improvement in glaucoma/ocular hypertension with the treatment of 0.002%w/v with one drop (20uL/eye) - as it is showing the reduction of intraocular pressure that is expected as taught by the recited claims and Matsou (and Kambe). The recited claims are for treating glaucoma with sepetaprost wherein it is expected to treat glaucoma/IOP and Matsou addressed that sepetaprost (ONO-9054) had strong and long lasting hypotensive effect with favorable safety profiles such as marked reductions in IOP across all treatment groups proportionate with dose concentrations like -7mmHg following single dosing, and had the potential to have a more robust reduction of IOP thanks to the co-simulation of two receptors and that it had a more potent and sustainable IOP lowering effect than two PGAs. Additionally, the example of the specification is not commensurate in scope with the claims as written – the example is to treatment of glaucoma/ocular hypertension with a drop of 0.002%w/v with sepetaprost (20uL/eye) to monkeys with an inadequate response to latanoprost, while the breath claimed is substantially broader to any active and with no dosing or concentration recited commensurate with the example.
As for assertion that Matsou teaches away from the use of sepetaprost, this is not persuasive as Matsou et al. established that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) and more than 30% of glaucoma patients on PGA treatment will need additional medical treatment a few years down the line (where the treatment stops working), Matsou expresses and highlights the need for more potent, more efficacious and more tolerable drugs to existing therapies and presents the most promising treatments including sepetaprost with its dual action with favorable safety profile; wherein it is prima facie obvious to utilize the new treatment like sepetaprost for those who do not respond to conventional prostaglandins and those on who need medical treatment after being on PGA treatment for a few years (where it no longer is effective/refractory) with a reasonable expectation of success. As it is conventional medical practice to use a known first line treatment (i.e. prostaglandins) and then use a new/different treatment for the condition when the one being used is not effective or no longer effective in order to find a treatment that is useful for the condition – as one does not forgo treatment when there are available actives (i.e. doctors give a known conventional treatment and if not successful or no longer effective, give a new/different drug treatment in order to treat the condition as one does not leave the patient untreated). The assertion that Matsou et al. teaches away from using sepetaprost as prostaglandins and sepetaprost have completely different chemical structures and mechanisms of action is not persuasive as Matsou et al. establishes sepetaprost to be one of the promising agents for glaucoma as it has a more potent and sustainable effect on intraocular pressure because of its dual mechanism of action wherein its use for glaucoma including the patients that Matsou addresses as being in need of treatment that are not responding to conventional prostaglandin treatment and those who will need additional therapy (refractory) is prima facie obvious with a reasonable expectation of success. As for the assertion that Matsou only addresses omidenepag isopropyl for patients that were non/low responders to latanoprost where one would not be motivated to substitute sepetaprost for omidenepag isopropyl is fully considered but not persuasive as Matsou addresses that omidenepag isopropyl was compared to latanoprost in various trials and then investigated in non/low responders to latanoprost which demonstrates the expected progression in use for glaucoma actives; and Matsou establishes sepetaprost to be one of the promising agents for glaucoma it is prima facie obvious to use it for the glaucoma patients that may not respond to prostaglandins or those on PGA treatment that will need additional treatment later as described by Matsou with a reasonable expectation of success.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Accordingly, the rejection stands.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 of U.S. Patent No. 12201602 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-13, 18-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
Rejection:
The teachings of the patented claims in view of Matsou et al. are addressed above.
The patented claims in view of Matsou et al. do not expressly recite the exact claimed values for sepetaprost but does teach the compound to be for reducing intraocular pressure and treating glaucoma/ocular hypertension.
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed in an eyedrop at various concentrations including 10µg/ml (0.001%w/v) and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations in an eyedrop as suggested by Suto et al. and produce the claimed invention; it is prima facie obvious to administer sepetaprost as an eyedrop in its known concentrations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the recited claims and Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto as not teaching administering sepetaprost as an active ingredient to a patient for whom other therapeutic agent for glaucoma/ocular hypertension is inadequately effective. This is fully considered but not persuasive as it is to Suto reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Suto is presented merely to demonstrate the known concentration for sepetaprost for lowering intraocular pressure and utilizing a known concentration that is within the taught range as a means of optimizing the drug to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success.
Accordingly, the rejection stands.
Claims 10-13, 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-14 of U.S. Patent No. 11446273 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
The patented claims are directed to the method of treating glaucoma/ocular hypertension with the simultaneous or concomitant administration of sepetaprost and at least one of ripasudil or a salt thereof.
The patented claims do not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost (in combination with ripasudil and/or its salt) but does claim treating glaucoma/ocular hypertension with sepetaprost (in combination with ripasudil and/or its salt).
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (along with its combination treatment with ripasudil) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) wherein other treatments like sepetaprost would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment as directed by Matsou with a reasonable expectation of success as the patented claims teaches that sepetaprost and its combination treatment is useful in the treatment of glaucoma with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to the recited claims and Matsou which are the same as those presented to U.S. Pat. 12201602 and are addressed above.
Accordingly, the rejection stands.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-14 of U.S. Patent No. 11446273 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-13, 18-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
Rejection:
The teachings of the patented claims in view of Matsou et al. are addressed above.
The patented claims in view of Matsou et al. do not expressly recite the exact claimed values for sepetaprost but does teach the compound to be for reducing intraocular pressure and treating glaucoma/ocular hypertension.
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed in an eyedrop at various concentrations including 10µg/ml (0.001%w/v) and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations in an eyedrop as suggested by Suto et al. and produce the claimed invention; it is prima facie obvious to administer sepetaprost as an eyedrop in its known concentrations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the recited claims and Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto to the reference individually which is not persuasive as addressed above.
Accordingly, the rejection stands.
Claims 10-13, 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12161629 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
The patented claims are directed to the method of treating glaucoma/ocular hypertension with the topical administration of an eyedrop of about 0.3-about 0.7mg phentolamine mesylate and a second active that includes ONO-9054 (sepetaprost).
The patented claims do not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost (in combination with phentolamine mesylate) but does claim treating glaucoma/ocular hypertension with sepetaprost (in combination with phentolamine mesylate).
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (along with its combination treatment with phentolamine mesylate) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) wherein other treatments like sepetaprost would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment as directed by Matsou with a reasonable expectation of success as the patented claims teaches that sepetaprost and its combination treatment is useful in the treatment of glaucoma with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to the recited claims and Matsou which are the same as those presented to U.S. Pat. 12201602 and are addressed above.
Accordingly, the rejection stands.
Claims 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12161629 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-13, 17-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
Rejection:
The teachings of the patented claims in view of Matsou et al. are addressed above.
The patented claims in view of Matsou et al. do not expressly recite the exact claimed values for sepetaprost but does teach the compound to be for reducing intraocular pressure and treating glaucoma/ocular hypertension.
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed in an eyedrop at various concentrations including 10µg/ml (0.001%w/v) and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations in an eyedrop as suggested by Suto et al. and produce the claimed invention; it is prima facie obvious to administer sepetaprost as an eyedrop in its known concentrations with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to the recited claims and Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto to the reference individually which is not persuasive as addressed above.
Accordingly, the rejection stands.
Claims 10-13, 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 16954416 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
The copending claims are directed to the method of treating glaucoma/ocular hypertension with the simultaneous or concomitant administration of sepetaprost and timolol or its maleate salt.
The copending claims do not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost (in combination with timolol or its maleate salt) but does claim treating glaucoma/ocular hypertension with sepetaprost (in combination with timolol or its maleate salt).
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (along with its combination treatment with timolol) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) wherein other treatments like sepetaprost would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment as directed by Matsou with a reasonable expectation of success as the patented claims teaches that sepetaprost and its combination treatment is useful in the treatment of glaucoma with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are to the recited claims and Matsou which are the same as those presented to U.S. Pat. 12201602 and are addressed above.
Accordingly, the rejection stands.
Claims 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 16954416 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-13, 18-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
The teachings of the copending claims in view of Matsou et al. are addressed above.
The copending claims in view of Matsou et al. do not expressly recite the exact claimed values for sepetaprost but does teach the compound to be for reducing intraocular pressure and treating glaucoma/ocular hypertension.
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed in an eyedrop at various concentrations including 10µg/ml (0.001%w/v) and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations in an eyedrop as suggested by Suto et al. and produce the claimed invention; it is prima facie obvious to administer sepetaprost as an eyedrop in its known concentrations with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are those to the recited claims and Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto to the reference individually which is not persuasive as addressed above.
Accordingly, the rejection stands.
Claims 10-13, 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 19318278 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma).
The copending claims are directed to the method of treating glaucoma/ocular hypertension with the simultaneous or concomitant administration of sepetaprost and a beta-blocker or its pharmaceutical salt.
The copending claims do not expressly recite that the patient was not responsive (refractory) to another glaucoma/ocular hypertensive agent prior to treating the glaucoma/ocular hypertension with sepetaprost (in combination with a beta-blocker or its pharmaceutical salt) but does claim treating glaucoma/ocular hypertension with sepetaprost (in combination with a beta-blocker or its pharmaceutical salt).
Matsou et al. teaches that prostaglandin F2α analogs (PGA’s) were the first prostaglandin agonist used for glaucoma treatment - but a small yet significant percentage of patient will not respond to currently available PGA therapy, and even bimatoprost while superior efficacy than latanoprost (both currently available PGA’s, abstract, Page 777 Col. 1) have troublesome side effect that limits its use (Page 778 section 3 Current PGAs: lack of efficacy and side effects); wherein there is a strong incentive for the development of novel therapies with enhanced efficacy profiles, longer lasting hypertensive effects and improved safety profile which include EP receptor agonists like ONO-9054/sepetaprost which has dual receptor activity and more potent and sustainable IOP lowering effects than with latanoprost and travoprost with a favorable safety profile (Page 779 section 4 Future research aims- section 5 EP receptor agonists Col. 2 first paragraph, Page 780-781 section 5.5 ONO 9054 (de-127, sepetaprost)). Up to 15% of glaucoma patient may not respond to prostaglandins F2a but ONO 9054 is a promising agent as it targets both FP and EP3 receptors (Page 783 Col. 1 paragraph 3 and Col. 2 2nd paragraph).
Wherein it would be obvious to one of ordinary skill in the art to utilize sepetaprost (along with its combination treatment with timolol) when a glaucoma patient does not respond to prostaglandins F2a treatment as suggested by Matsou et al. and produce the claimed invention; as Matsou et al. establishes that up to 15% of glaucoma patients may not respond to conventional prostaglandins F2a therapy ((implicit that patients have been treated with conventional prostaglandin F2a therapy like latanoprost and did not respond to it) wherein other treatments like sepetaprost would be useful for treating these patients with its dual action with favorable safety profile and would be prima facie obvious to utilize the new treatment as directed by Matsou with a reasonable expectation of success as the patented claims teaches that sepetaprost and its combination treatment is useful in the treatment of glaucoma with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are to the recited claims and Matsou which are the same as those presented to U.S. Pat. 12201602 and are addressed above.
Accordingly, the rejection stands.
Claims 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 19318278 in view of Matsou et al. (Investigational drugs targeting prostaglandin receptors for the treatment of glaucoma) as applied to claims 10-13, 18-19 above, further in view of Suto et al. (A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers-Abstract).
The teachings of the copending claims in view of Matsou et al. are addressed above.
The copending claims in view of Matsou et al. do not expressly recite the exact claimed values for sepetaprost but does teach the compound to be for reducing intraocular pressure and treating glaucoma/ocular hypertension.
Suto et al. teaches that sepetaprost (ONO-9054) is known to be dosed in an eyedrop at various concentrations including 10µg/ml (0.001%w/v) and 20µg/ml (0.002%w/v) for lowering intraocular pressure.
Wherein it would be obvious to one of ordinary skill in the art to utilize known sepetaprost concentrations in an eyedrop as suggested by Suto et al. and produce the claimed invention; it is prima facie obvious to administer sepetaprost as an eyedrop in its known concentrations with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant's arguments are those to the recited claims and Matsou et al. which are addressed above. Applicant’s remaining arguments are to Suto to the reference individually which is not persuasive as addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 10-19 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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