DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of edonentan as the endothelin receptor antagonist, neovascular age-related macular degeneration as the condition, intravitreal injection as the means of administration, and a ocular implant as the composition form in the reply filed on 04/06/2026 is acknowledged. Upon review the endothelin receptor antagonist is expanded to include tezosentan, enrasentan, A-182086, clazosentan (also known as VML 588, Ro 61-1790, AXV-034343); the condition is expanded to include diabetic retinopathy and glaucoma, the means of administration is expanded to include topical administration to the eye with composition forms like eye drops.
Status of Application
Applicant has elected edonentan as the endothelin receptor antagonist, neovascular age-related macular degeneration as the condition, intravitreal injection as the means of administration, and a ocular implant as the composition form for the examination. Upon review the endothelin receptor antagonist is expanded to include tezosentan, enrasentan, A-182086, clazosentan (also known as VML 588, Ro 61-1790, AXV-034343); the condition is expanded to include diabetic retinopathy and glaucoma, the means of administration is expanded to include topical administration to the eye with composition forms like eye drops.
Claims 1, 3, 40-53 are pending.
Claims 1, 3, 40-53 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
The information disclosure statement filed 05/14/2024 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gurkan et al. (WO 2021/087399) .
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Rejection:
Gurkan et al. teaches treating glaucoma and diabetic retinopathy with the administration of edonentan to the eye (claims 1-6, Example 7, see full document specifically areas cited).
All the critical elements are taught by the cited reference and thus the claims are anticipated.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gurkan et al. (WO 2021/158663) .
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Rejection:
Gurkan et al. teaches treating glaucoma and diabetic retinopathy with the administration of edonentan to the eye (claims 11-21, see full document specifically areas cited).
All the critical elements are taught by the cited reference and thus the claims are anticipated.
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 1, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763).
Rejection:
Yorio et al. teaches treating ocular conditions including glaucoma and macular degeneration (i.e. age-related macular degeneration) and diabetic retinopathy (all known neovascular eye conditions), with one or more endothelin antagonists such as bosentan (claim 3, 4-tert-butyl-N-[6-(2-hydroxy-ethoxy-5-2methoxy-phenoxy-[2,2′]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate), sitaxsentan (claim 12), A192621 (claim 6), and PD145065 (claim 5). (abstract, [4, 15-16, 19, 26], claims 1, 3, 5, 12, 16-17). Yorio et al. teaches that ET antagonists (endothelin antagonists) are known to be used in the treatment of cardiovascular diseases [44] and can be used for treating these ocular conditions [14-15]. The ET antagonists can be administered topically and intraocularly injection like retrobulbar and intravitreally (claims 16-17 [14-16, 26]). The ET antagonist can be in various forms of ophthalmic compositions including solutions and dosage forms adapted to topical, intravitreal or intracameral use [89]. Can be formulated with various excipients and carriers including buffers, preservatives, viscosity agents [90-92]. Topical administration of ET antagonist will generally range between about 0.01-5%w/v preferably 0.25-1%w/v [93]. The exact dosage to the patient will vary and be determine by clinician skilled in the art as various factors affect the dosage amount including the efficacy of the ET antagonist, severity of condition, and health of the patient [88]. Dosages can be readily determined by one of ordinary skill in the art and can be readily formulated into pharmaceutical dosing entities [95]. ET antagonist in Tables 1-2 are representative and the invention includes any agent related in structure and pharmacology to these agents ([95, 102], see full document specifically areas cited).
Yorio et al. does not expressly teach the inclusion of edonentan (also known as BMS-207940) but does teach treating ocular conditions like macular degeneration and diabetic retinopathy and glaucoma (all neovascular) with endothelin antagonists like as bosentan, sitaxsentan, and PD145065; and administering it topically and intravitreally in ophthalmic dosage forms for topical and intravitreal use including drops. Yorio et al. also teaches the ET antagonist can in Tables 1-2 are representative and can includes any agent related in structure and pharmacology to these agents.
Gulati teaches that known endothelin antagonists bosentan, BMS-207940 (edonentan), tezosentan, sitaxsentan, enrasentan, VML 588/Ro 61-1790 (clazosentan), PD 145065, A-192621, and mixtures thereof (claim 18).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an endothelin antagonists like BMS-207940 (edonentan), tezosentan, enrasentan, or VML 588/Ro 61-1790 (clazosentan) as suggested by Gulati and produce the claimed invention; as simple substitution of one known endothelin antagonists for another is prima facie obvious and it is also prima facie obvious to incorporate another endothelin antagonists for its additive therapeutic effect with a reasonable expectation of success particular as Yorio et al. teaches the inclusion endothelin antagonists for the method of treatment and that other endothelin antagonists can be utilized for the method.
Claims 40-41, 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763) as applied to claims 1,3 above, further in view of www.brightfocus.org (Forms of Macular Degeneration).
Rejection:
The teachings of Yorio et al. in view of Gulati are addressed above. The prior art also teaches the ET antagonist to be administered by various means including intravitreally by injection (implicitly an implant, Example 10 is also an injection/implant with biodegradable ingredients) and topically like drops.
Yorio et al. in view of Gulati do not expressly recite the macular degeneration is the neovascular form but does recite treating macular degeneration (all forms).
www.brightfocus.org teaches that macular degeneration is the leading cause of vision in people of 60 (age-related) and presents in two forms: wet and dry, and the wet form presents with neovascularization.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the wet macular degeneration as suggested by www.brightfocus.org and produce the claimed invention; as it is prima facie obvious to treat the various forms of age related macular degeneration including the wet form of macular degeneration (neovascular) with a reasonable expectation of success. The therapeutic effect would intrinsically present with an improvement of symptoms of the condition include neovascularization (tissue/retinal perfusion, less neovascularization).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763) and www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47-50 above, further in view of www.maculardegeneration.net (Vision Tests: Visual Acuity Test and Amsler Grid).
Rejection:
The teachings of Yorio et al. in view of Gulati are addressed above.
Yorio et al. in view of Gulati do not expressly recite the testing and measurement of the macular degeneration progress.
www.maculardegeneration.net teaches that visual acuity tests and Amsler grid (visual field, contrast sensitivity) are known to be used to diagnosis the condition and to monitor your progress.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use visual acuity tests and Amsler grid (visual field, contrast sensitivity) as suggested by www.maculardegeneration.net and produce the claimed invention; as it is prima facie obvious to use conventional means to monitor the progress of the treatment wet/neovascular AMD with a reasonable expectation of success.
Claims 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763) and www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47-50 above, further in view of German et al. (Reliability of drop size from multi-dose eye drop bottles: is it cause for concern?-abstract only).
Rejection:
The teachings of Yorio et al. in view of Gulati and www.brightfocus.org are addressed above.
Yorio et al. in view of Gulati and www.brightfocus.org does not expressly recited the exact claimed dose values but does expressly teach administration of the ET antagonist to be about 0.01-5%w/v (about 0.01-5g/100ml=0.1-50mg/ml) and can be given various means including intravitreally by injection and topically like drops, and that exact dosage to the patient will vary and be determine by clinician skilled in the art as various factors affect the dosage amount including the efficacy of the ET antagonist, severity of condition, and health of the patient.
German et al. teaches that eye drops have a volume from 33.8-63.4microliters.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the dose of the ET antagonist as suggested by German et al. and produce the claimed invention; as while the prior art does not recited the exact claimed values they embrace the claimed values (about 0.01-5%w/v = about 0.01-5g/100ml=0.1-50mg/ml=0.1-50ug/ul with average eyedrop volume of 33.8-63.4microliters=about 3.38-3170 micrograms per drop) and the prior art teaches that exact dosage to the patient will vary and be determine by clinician skilled in the art as various factors affect the dosage amount including the efficacy of the ET antagonist, severity of condition, and health of the patient wherein it is prima facie obvious to one of skill in the art to optimize within the range and attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763) and www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47-50 above, further in view of Gurkan et al. (WO 2021/158663).
Rejection:
The teachings of Yorio et al. in view of Gulati and www.brightfocus.org are addressed above.
Yorio et al. in view of Gulati and www.brightfocus.org does not expressly the form of the edonentan but does teach the inclusion of edonentan.
Gurkan et al. teaches that edonentan can be in crystalline forms like form 4 (X-ray diffraction with at least 3 peaks at 5.6±0.2°, 11.4±0.2°, 17.7±0.2°, 19.3±0.2°, 21.1±0.2°, and 21.9±0.2°) and are useful for eye conditions (abstract, claim 1-5).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known crystalline form like form 4 as suggested by Gurkan et al. and produce the claimed invention; as it is prima facie obvious to utilize the known crystalline form of edonentan with a reasonable expectation of success absent evidence of criticality for the specific crystalline form.
Claims 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Yorio et al. (U.S. Pat. 2003/0176356) in view of Gulati (U.S. Pat. Pub. 2008/0207763) and www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47-50 above, further in view of Wu et al. (U.S. Pat. Pub. 2014/0086974).
Rejection:
The teachings of Yorio et al. in view of Gulati and www.brightfocus.org are addressed above.
Yorio et al. in view of Gulati and www.brightfocus.org does not expressly the polymer components of the intravitreal composition/implant but does teach the intravitreal implantation/administration of edonentan for treating ocular conditions including wet AMD.
Wu et al. teaches that intravitreal drug implants for treating the eye including for macular degeneration are known and contains a biodegradable polymer matrix that include RESOMER RG752S, RESOMER RG753S, RESOMER RG502H, RESOMER RG503H, or a combination thereof [132-137] ;and actives like antiproliferative compounds that are from about 1-about 50% (abstract, [15, 25, 72, 84-85, 125, 132-137]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the edonentan in the intravitreal implant as suggested by Wu et al. and produce the claimed invention; as it is prima facie obvious to incorporate the active in a known ophthalmic intravitreal implant as the prior art teaches intravitreal placement with a reasonable expectation of success, and to optimize within the known range and polymer combinations to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the specific polymers and concentration values.
Claims 1, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124).
Rejection:
Lecouteur et al. teaches treating age related disease including age-related macular degeneration with the administration of endothelin receptor antagonist including edonentan (claim 6, 12-14). The active can be administered topically and by injection [136, 141]. The composition can comprise the therapeutic in the range of about 0.1-2000mg [143], but the dosage regimen depends on a variety of factors including the age, weight, severity of the disease, route and frequency of administration, as well as the pharmacokinetic properties (e.g., adsorption, distribution,) of the individual treated, and thus may vary widely; wherein the treatments may be administered as often as necessary judged necessary by the treating physician. One of skill in the art will appreciate that the dosage regime or therapeutically effective amount of the compound to be administrated may need to be optimized for each individual ([142-143], see full document).
While Lecouteur et al. does not exemplify treating AMD with edonentan topically, Lecouteur et al. does expressly teach treating it wherein exemplification of the express teaching is prima facie obvious with a reasonable expectation of success.
Claims 40-41, 47 are rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) as applied to claims 1, 3 above, in view of www.brightfocus.org (Forms of Macular Degeneration).
Rejection:
The teachings of Lecouteur et al. are addressed above. The prior art also teaches the ET antagonist to be administered by various means including topical and injection.
Lecouteur et al. do not expressly recite the age-related macular degeneration is the specific neovascular form but does recite treating age-related macular degeneration (both forms).
www.brightfocus.org teaches that macular degeneration is the leading cause of vision in people of 60 (age-related, AMD) and presents in two forms: wet and dry, and the wet form presents with neovascularization.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the wet macular degeneration as suggested by www.brightfocus.org and produce the claimed invention; as it is prima facie obvious to treat the various forms of age related macular degeneration including the wet form of macular degeneration (neovascular) with a reasonable expectation of success. The therapeutic effect would intrinsically present with an improvement of symptoms of the condition include neovascularization (tissue/retinal perfusion, less neovascularization).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47 above, further in view of www.maculardegeneration.net (Vision Tests: Visual Acuity Test and Amsler Grid).
Rejection:
The teachings of Lecouteur et al. in view of www.brightfocus.org are addressed above.
Lecouteur et al. in view of www.brightfocus.org do not expressly recite the testing and measurement of the macular degeneration progress.
www.maculardegeneration.net teaches that visual acuity tests and Amsler grid (visual field, contrast sensitivity) are known to be used to diagnosis the condition and to monitor your progress.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use visual acuity tests and Amsler grid (visual field, contrast sensitivity) as suggested by www.maculardegeneration.net and produce the claimed invention; as it is prima facie obvious to use conventional means to monitor the progress of the treatment wet/neovascular AMD with a reasonable expectation of success.
Claims 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47 above, further in view of Marx et al. (PRIMARY PACKAGING - Ophthalmic Squeeze Dispenser (OSD): Does One Size Fit All?) and German et al. (Reliability of drop size from multi-dose eye drop bottles: is it cause for concern?-abstract only).
Rejection:
The teachings of Lecouteur et al. in view of www.brightfocus.org are addressed above.
Lecouteur et al. in view of www.brightfocus.org does not expressly teach the recited the exact claimed dose values but does expressly teach the composition comprise the therapeutic (i.e. edonentan) in the range of about 0.1-2000mg [143], but the dosage regimen depends on a variety of factors including the age, weight, severity of the disease, route and frequency of administration of the individual treated, and thus may vary widely; and judged by the treating physician. One of skill in the art will appreciate that the dosage regime or therapeutically effective amount of the compound to be administrated may need to be optimized for each individual.
Marx et al. teaches that standard eyedrop botte is 10ml (Page 5 last paragraph).
German et al. teaches that eye drops have a volume from 33.8-63.4microliters.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the dose of the edonentan as suggested by Marx et al. and German et al. and produce the claimed invention; as while the prior art does not recited the exact claimed values they are embrace as the standard volume of eyedrop containers are 10ml with the composition comprise the edonentan from about 0.1-2000mg (about 0.1mg/10ml-2000mg/10ml=0.01mg/ml-200mg/ml=0.01ug/ul-200ug/ul) and the average eyedrop volume of 33.8-63.4microliters=about 0.338 microgram -12.68milligram per drop) and the prior art teaches optimizing the dose for each individual as determined by clinician skilled in the art as various factors wherein it is prima facie obvious to one of skill in the art to optimize within the range and attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claims 48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47 above, further in view of Lang (Ocular drug delivery conventional ocular formulations).
Rejection:
The teachings of Lecouteur et al. in view of www.brightfocus.org are addressed above.
Lecouteur et al. in view of www.brightfocus.org do not expressly recite the injection to the eye or the specific excipients for the formulation.
Lang teaches that known conventional ocular formulations include solutions/drops and ocular injections (Table 1, Table 4), which contain various known excipients including buffers and preservatives (Table 2 and 3).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate buffers and preservatives in conventional means of ophthalmic administration like topical solutions/drops and ocular injections as suggested by Lang and produce the claimed invention; as it is prima facie obvious to utilize conventional ocular means for administration and their known conventional components/excipients with a reasonable expectation of success.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) as applied to claims 40-41, 47 above, further in view of Gurkan et al. (WO 2021/158663).
Rejection:
The teachings of Lecouteur et al. in view of www.brightfocus.org are addressed above.
Lecouteur et al. in view of www.brightfocus.org does not expressly the form of the edonentan but does teach the inclusion of edonentan.
Gurkan et al. teaches that edonentan can be in crystalline forms like form 4 (X-ray diffraction with at least 3 peaks at 5.6±0.2°, 11.4±0.2°, 17.7±0.2°, 19.3±0.2°, 21.1±0.2°, and 21.9±0.2°) and are useful for eye conditions (abstract, claim 1-5).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known crystalline form like form 4 as suggested by Gurkan et al. and produce the claimed invention; as it is prima facie obvious to utilize the known crystalline form of edonentan with a reasonable expectation of success absent evidence of criticality for the specific crystalline form.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) and Lang (Ocular drug delivery conventional ocular formulations) as applied to claims 48 and 50 above, further in view of Janoria et al. (Novel approaches to retinal drug delivery).
Rejection:
The teachings of over Lecouteur et al. in view of www.brightfocus.org and Lang are addressed above.
Lecouteur et al. in view of www.brightfocus.org and Lang do not expressly recite intravitreal injection but does teach ocular injection.
Janoria et al. teaches that known ocular injections include intravitreal injections/implants for conditions including AMD (section 1.1, section 3, Figure 1, section 3.1).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize intravitreal injections/implants as suggested by Janoria et al. and produce the claimed invention; as it is prima facie obvious to utilize known ocular injections for its known purpose with a reasonable expectation of success.
Claims 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Lecouteur et al. (WO 2019/109124) in view of www.brightfocus.org (Forms of Macular Degeneration) and Lang (Ocular drug delivery conventional ocular formulations) and Janoria et al. (Novel approaches to retinal drug delivery) as applied to claim 49 above, further in view of Wu et al. (U.S. Pat. Pub. 2014/0086974).
Rejection:
The teachings of Lecouteur et al. in view of www.brightfocus.org and Lang and Janoria et al. are addressed above.
Lecouteur et al. in view of www.brightfocus.org and Lang and Janoria et al. does not expressly the polymer components of the intravitreal composition/implant but does teach the intravitreal implantation/administration of edonentan for treating ocular conditions including wet AMD.
Wu et al. teaches that intravitreal drug implants for treating the eye including for macular degeneration are known and contains a biodegradable polymer matrix that include RESOMER RG752S, RESOMER RG753S, RESOMER RG502H, RESOMER RG503H, or a combination thereof [132-137] ;and actives like antiproliferative compounds that are from about 1-about 50% (abstract, [15, 25, 72, 84-85, 125, 132-137]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the edonentan in the intravitreal implant as suggested by Wu et al. and produce the claimed invention; as it is prima facie obvious to incorporate the active in a known ophthalmic intravitreal implant as the prior art teaches intravitreal placement with a reasonable expectation of success, and to optimize within the known range and polymer combinations to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the specific polymers and concentration values.
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 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11738007.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recited treating a glaucoma with the same active by injection to the eye wherein it falls within the breath instantly claimed and therein obvious.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-36 of copending Application No. 19397828 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recited treating a diabetic retinopathy with the same active by injection/intravitreal implant to the eye wherein it falls within the breath instantly claimed and therein obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-27, 29-35, 37-42, 44-48 of copending Application No. 18345514 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recited treating glaucoma with the same active by applying to the optical tissue wherein it falls within the breath instantly claimed and therein obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25-43 of copending Application No. 18976033 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recited treating a diabetic retinopathy with the same active by contacting optical tissue wherein it falls within the breath instantly claimed and therein obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 20-21, 25, 28, 30, 82-83 of copending Application No. 18528378 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recited treating glaucoma or diabetic retinopathy with the same active by applying to the optical tissue wherein it falls within the breath instantly claimed and therein obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3, 40-53 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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