DETAILED ACTION
Election/Restrictions
Applicant’s election for the species of Compound A
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without traverse in the reply filed on 07/22/2026 is acknowledged.
Status of Application
Applicant has elected Compound A as the species for the examination.
Claims 7-16 are pending.
Claims 7-16 are present for examination at this time.
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed 3/28/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it does not have translation of the cited reference(s). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed 3/28/2025 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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 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 7-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jordan et al. (U.S. Pat. Pub. 2007/0135481) in view of Loftsson (U.S. Pat. 5472954).
Rejection:
Jordan et al. teaches treating macular degeneration with an ophthalmic composition like as eye drops (topical), comprising drug compounds including
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(compound A, lipophilic compound, [28, 100, 208], claim 3), and a pharmaceutical carrier. The forms of macular degeneration for treatment include Stargardt disease and age related macular degeneration -both wet and dry forms, and other retinal diseases with etiology involving the accumulation of A2E and/or lipofuscin [3-4, 9, 50, 66, 145-146, 196, 198]. The amount of active is about 0.1-75% [206]. The ophthalmic compositions are isotonic and the pH is adjusted so there is no irritation of the eye. The pharmaceutical carriers include encapsulating materials, sugars, cellulose, and phosphate buffered solutions (also known as PBS, [104]). Jordan also teaches improving solubility with prodrug forms [111] and additional additives like stabilizers and penetration enhancers and solution promoters ([206, 208], see full document specifically areas cited).
Jordan et al. does not expressly teach the inclusion of beta-cyclodextrin sulfobutylether but does teach the inclusion of encapsulating materials, sugars, and stabilizers, along with prodrug forms to improve solubility of the drug.
Loftsson teaches that it is known to improve the solubility and stability of lipophilic actives in aqueous mediums with the inclusion of cyclodextrins from about 0.1-about 70%w/v and a water soluble polymer like cellulose (col. 7 line 19-22, Col.4 line 3-8 and 17-20 and 42-50, claim 26). The cyclodextrins include beta-cyclodextrin sulfobutylether (Col. 6 line 58-62) which form inclusion complexes (encapsulating material, col. 1 line 64-Col 2 line 7) therein improve the solubility and stability of lipophilic actives in aqueous mediums (col. 4 line 2-8, stabilizer and solution promotor). Loftsson teaches that it is applicable to ophthalmic compositions (Col.19 Line 16-31).
It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate cyclodextrin such as beta-cyclodextrin sulfobutylether in the ophthalmic composition, as suggested by Loftsson, and produce the instant invention as it is prima facie obvious to incorporate additives like beta-cyclodextrin sulfobutylether which are not only embraced by the prior art of Jordan et al. (is a stabilizer, solution promoter, and an encapsulating material), but they also improve both the solubility and stability of lipophilic actives which is desirable with a reasonable expectation of success absent evidence of criticality for the claimed beta-cyclodextrin sulfobutylether form of cyclodextrin.
While the prior art does not teach the exact claimed values for the amount of cyclodextrin, it does teach ranges that either embraces it or overlaps it; wherein it would be prima facie obvious for one of ordinary skill in the art at the time of the claimed invention 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/values by routine experimentation when the general conditions of a claim are disclosed in the prior art absent evidence for the criticality for the claimed values.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jordan et al. (U.S. Pat. Pub. 2007/0135481) in view of Loftsson (U.S. Pat. 5472954) as applied to claims 7-8 above, further in view of Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only).
Rejection:
The teachings of Jordan et al. in view of Loftsson are addressed above.
Jordan et al. in view of Loftsson does not expressly teach the beta-cyclodextrin sulfobutylether to be a sodium salt.
Ueda et al. teaches that the beta-cyclodextrin sulfobutylether sodium salt is known and known to be a solubilizing/stabilizing agent for poorly water soluble (lipophilic) drugs.
It would have been obvious to one of ordinary skill in the art at the time of the invention as Jordan et al. in view of Loftsson address the inclusion of beta-cyclodextrin sulfobutylether and Ueda et al., addresses that its sodium salt form is known and useful for the same solubilizing/stabilizing purpose, wherein its inclusion is prima facie obvious with a reasonable expectation of success absent evidence for the criticality for the particular salt form.
Claims 10-13, 15-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jordan et al. (U.S. Pat. Pub. 2007/0135481) in view of Loftsson (U.S. Pat. 5472954) and Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only) as applied to claim 9 above, further in view of FDA (BAM R59: Phosphate-Buffered Saline (PBS), pH 7.4).
Rejection:
Jordan in view of Loftsson and Ueda et al. are addressed above, including the administration of the claimed compound for the treatment of macular degeneration including Stargardt disease and age related macular degeneration -both wet and dry forms; and the optimization of the cyclodextrin within the taught ranges and arrive at the claimed values absent evidence for the criticality for the claimed values.
Jordan in view of Loftsson and Ueda et al. do not expressly teach the pH of the composition but does teach that the pH is adjusted so there is no irritation of the eye and the inclusion of phosphate buffered saline (PBS).
The FDA teaches that the Phosphate-Buffered Saline (PBS) has a pH 7.4.
Wherein it is prima facie obvious that the PBS of the prior art has a pH of 7.4 and being the carrier buffer for the composition would have a pH of the carrier (7.4) which is near neutral and not irritate the eye. Additionally, it would also be obvious to have a pH at neutral as it would not irritate the eye which is the desired level as taught by Jordan with a reasonable expectation of success.
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jordan et al. (U.S. Pat. Pub. 2007/0135481) in view of Loftsson (U.S. Pat. 5472954), Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only) and FDA (BAM R59: Phosphate-Buffered Saline (PBS), pH 7.4) as applied to claims 10-13, 15-16 above, further in view of Howes et al. (Dry AMD: From Theory to Treatment).
Rejection:
Jordan in view of Loftsson, Ueda et al, and FDA are addressed above.
Jordan in view of Loftsson, Ueda et al, and FDA do not expressly teach treating geographic atrophy secondary to dry AMD but does teach treating macular degeneration including dry AMD.
Howes et al. teaches that the end stage of dry AMD is termed geographic atrophy (first paragraph).
Wherein it is obvious to one of skill in the art to treat geographic atrophy as suggested by Howes et al. and produce the claimed invention; as it is prima facie obvious to treat all the forms of dry AMD including the end stage form of geographic atrophy with a reasonable expectation of success. level as taught by Jordan with a reasonable expectation of success.
Double Patenting
Claims 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 7973025 in view of Loftsson (U.S. Pat. 5472954).
Although the conflicting patented claim 2 is not identical, it are not patentably distinct from each other because the instant compound are disclosed therein.
The claims of the patent do not teach the specific utility of its use in macular degeneration recited in the instant claims.
However it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to arrive at this utility because the patent disclosure teaches this utility for treating macular degeneration and its various forms including wet/dry AMD and Stargardt with administration including eyedrops (e.g. Abstract, Col. 46 line 33-64); wherein there are certain instances when the disclosure of the earlier patent may be used in the obviousness type double patenting analysis. The specification can be used as a dictionary to learn the meaning of a term in the patent claim and portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent; as the patented compounds must have a utility.
As the patent discloses the utility for treating macular degeneration and its forms for this compound in the known modalities, the nonstatutory obviousness double patenting exists between the patent and the instant claims.
Patented claim 3 recites treating macular degeneration with administration of the instant claimed compound.
The patented claims do not recite the presence of beta-cyclodextrin sulfobutylether.
Loftsson teaches that it is known to improve the solubility and stability of lipophilic actives in aqueous mediums with the inclusion of cyclodextrins from about 0.1-about 70%w/v and a water soluble polymer like cellulose (col. 7 line 19-22, Col.4 line 3-8 and 17-20 and 42-50, claim 26). The cyclodextrins include beta-cyclodextrin sulfobutylether (Col. 6 line 58-62) which form inclusion complexes (encapsulating material, col. 1 line 64-Col 2 line 7) therein improve the solubility and stability of lipophilic actives in aqueous mediums (col. 4 line 2-8, stabilizer and solution promotor). Loftsson teaches that it is applicable to ophthalmic compositions (Col.19 Line 16-31).
It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate cyclodextrin such as beta-cyclodextrin sulfobutylether in the ophthalmic composition, as suggested by Loftsson, and produce the instant invention as it is prima facie obvious to incorporate additives like beta-cyclodextrin sulfobutylether as they improve both the solubility and stability of lipophilic actives which is desirable with a reasonable expectation of success absent evidence of criticality for the claimed beta-cyclodextrin sulfobutylether form of cyclodextrin.
While the prior art does not teach the exact claimed values for the amount of cyclodextrin, it does teach ranges that either embraces it or overlaps it; wherein it would be prima facie obvious for one of ordinary skill in the art at the time of the claimed invention 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/values by routine experimentation when the general conditions of a claim are disclosed in the prior art absent evidence for the criticality for the claimed values.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 7973025 in view of Loftsson (U.S. Pat. 5472954) as applied to claims 7-8 above, further in view of Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only).
The teachings of the patented claims in view of Loftsson are addressed above.
The patented claims in view of Loftsson does not expressly teach the beta-cyclodextrin sulfobutylether to be a sodium salt.
Ueda et al. teaches that the beta-cyclodextrin sulfobutylether sodium salt is known and known to be a solubilizing/stabilizing agent for poorly water soluble (lipophilic) drugs.
It would have been obvious to one of ordinary skill in the art at the time of the invention as the patented claims in view of Loftsson address the inclusion of beta-cyclodextrin sulfobutylether and Ueda et al., addresses that its sodium salt form is known and useful for the same solubilizing/stabilizing purpose, wherein its inclusion is prima facie obvious with a reasonable expectation of success absent evidence for the criticality for the particular salt form.
Claims 10-13, 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 7973025 in view of Loftsson (U.S. Pat. 5472954) and Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only) as applied to claim 9 above, further in view of FDA (BAM R59: Phosphate-Buffered Saline (PBS), pH 7.4).
The teachings of the patented claims in view of Loftsson and Ueda et al. are addressed above.
The patented claims in view of Loftsson and Ueda et al. do not expressly teach the pH of the composition but does teach that the pH is adjusted so there is no irritation of the eye and the inclusion of phosphate buffered saline (PBS).
The FDA teaches that the Phosphate-Buffered Saline (PBS) has a pH 7.4.
Wherein it is prima facie obvious that the PBS of the prior art has a pH of 7.4 and being the carrier buffer for the composition would have a pH of the carrier (7.4) which is near neutral and not irritate the eye. Additionally, it would also be obvious to have a pH at neutral as it would not irritate the eye which is the desired level as taught by Jordan with a reasonable expectation of success.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of U.S. Patent No. 7973025 in view of Loftsson (U.S. Pat. 5472954), Ueda et al. (Evaluation of a sulfobutyl ether beta-cyclodextrin as a solubilizing/stabilizing agent for several drugs-Abstract only), and FDA (BAM R59: Phosphate-Buffered Saline (PBS), pH 7.4) as applied to claims 10-13, 15-16 above, further in view of Howes et al. (Dry AMD: From Theory to Treatment).
The patented claims in view of Loftsson, Ueda et al, and FDA are addressed above.
The patented claims in view of Loftsson, Ueda et al, and FDA do not expressly teach treating geographic atrophy secondary to dry AMD but does teach treating macular degeneration including dry AMD.
Howes et al. teaches that the end stage of dry AMD is termed geographic atrophy (first paragraph).
Wherein it is obvious to one of skill in the art to treat geographic atrophy as suggested by Howes et al. and produce the claimed invention; as it is prima facie obvious to treat all the forms of dry AMD including the end stage form of geographic atrophy with a reasonable expectation of success. level as taught by Jordan with a reasonable expectation of success.
Conclusion
Claims 7-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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