DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
Status of Application
The response filed 06/11/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claim 2-3 have been amended.
Claims 1, 4, 7, 16 have been cancelled.
Claims 19-22 have been added.
Applicant had previously elected choroidal neovascularization as the species genera and with the further election of the specific condition of age related macular degeneration for the examination.
Claims 2-3, 5-6, 8-9, 17-22 are pending.
Claims 2-3, 5-6, 8-9, 17-22 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 .
All grounds not addressed in the action are withdrawn or moot as a result of amendment or abandonment of the copending application.
New grounds of rejection are set forth in the current office action as a result of amendment.
Current Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Dependent claims 19-22 recite that “the solubilizing agent is at least one from the group consisting of surfactants, solvents, and mixtures thereof” or that “the solubilizing agent comprises at least one of surfactants”
The claims depend from claims 2-3 where the solubilizing agent is to the specific closed Markush group of
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The solubilizing agent of the dependent claims are broader than the Markush group from which it depends from as it is to generic surfactants or solvents, wherein it is indefinite as there is broad limitation together with a narrow limitation wherein it is unclear what the metes and bounds of the patent protection desired. Additionally, claims 21-22 recite that the solubilizing agent comprises at least one of the surfactants which is not only broad/generic but to the open language of “comprising” which is in conflict with the Markush grouping that they depend from which is closed language. It does not allow on to ascertain the metes and bounds of the claims as written. For purposes of examination, the claims are treated to the surfactant or solvents within the Markush group in the independent claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claims 19-22 recite that “the solubilizing agent is at least one from the group consisting of surfactants, solvents, and mixtures thereof” or that “the solubilizing agent comprises at least one of surfactants”; but the claims depend from claims 2-3 where the solubilizing agent is to the specific closed Markush group of
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Therein the solubilizing agent of the dependent claims are broader than the Markush group from which it depends from as it is to generic surfactants or solvents; and claims 21-22 also recite that the solubilizing agent comprises at least one of the surfactants which is not only broad/generic but to the open language of “comprising” which is in conflict with the Markush grouping that they depend from which is closed language.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 2-3, 5-6, 17-22 1-6, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. (KR101821593) in view of Beringer et al. (Ophthalmic Preparation -Buffer and pH, Additives).
Rejection:
Moon et al. teaches treating eye conditions including age-related macular degeneration with a pyrazole based compound as an active ingredient that is Formula I
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3-phenyl-4-propyl-1-(pyridin-2-yl) -1H-pyrazol-5-ol (APX-B, or 3-phenyl-4-n-propyl-1-(pyridin-2-yl) -1H-pyrazol-5-ol) and its hydrochloride salt
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3-phenyl-4-propyl-1-(pyridin-2-yl)-1H-pyrazole-5-ol hydrochloride (APX-115). The active is from 0.01-10% of the pharmaceutical composition, and the composition can contain various excipients including buffers/pH regulators and solubilizers; and can be in various formulations like solution/eyedrops (claims 1-7, 9-10; [1, 3, 8, 11-18, 20-24, 29, 35-38, 41-42,44-48, 51, 56-70]). Moon et al. also exemplifies treating an animal model for age-related macular degeneration with APX-115 (Example 8 [87-89], see full document specifically areas cited).
While Moon et al. does not recite the exact claimed values for instant claim 2-3, they are embraced and it is prima facie obvious to optimize within the taught range for the amount of the active and attain the instant claimed values and a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Moon et al. does not expressly recite the pH of the composition for the treatment or the types of solubilizers, but does teach the treatment of age-related macular degeneration with the compound (i.e. APX-115) in formulations like eyedrop with solubilizers and buffers/pH regulators.
Beringer et al. teaches that ophthalmic formulations should ideally be formulated to a pH of 7.4 which is the equivalent to the tear fluid (Buffers and pH 1st paragraph), and that common additives like surfactants like polysorbate 80 are used to aid in solubilization and stabilize drugs (polysorbate 80 is a polyoxyethylene sorbitan fatty acid ester, see solubilizers, Additives 4th paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the pH of the composition applied to the eye be about 7.4 and for the solubilizers to be surfactants like polysorbate 80 as suggested by Beringer et al. and produce the claimed invention; as it is prima facie obvious to formulate the pH of the composition administered to be at the ideal pH with a reasonable expectation of success. It is also prima facie obvious to incorporate known solubilizers like polysorbates such as polysorbate 80 (a polyoxyethylene sorbitan fatty acid ester) for their known purpose with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments filed 06/11/2026are centered on the assertion that Moon does not teach that the active would be effective for treating posterior eye disease by simple instillation (topical to the eye) and that Moon teaches the preferred administration by injection with the assertion that instillation is merely listed as an example, the assertion that there not a reasonable expectation of success for topical instillation as there is no data in Moon to demonstrate posterior segment delivery by instillation, and that the teaching in Beringer et al. for an ideal pH of 7.4 in ophthalmic formulation is merely an ideal target does not teach the range of 3.5-8.5, the assertion that the eyedrop formulations in Table 8 (Examples 1, 3, 10, 11, 13, 14, 16, 34) have greater concentration of the active in the vitreous when the comparative formulation are significantly lower being outside the pH range of 3.5-8.5; that while Moon et al. cites the claimed compound to be in an eyedrop it does not disclose or suggest improvement in drug delivery to the posterior segment by controlling the pH; and that there is no motivation to combine the references.
This has been fully considered but are not persuasive.
Applicant’s assertion that Moon et al. does not teach the active to be effective for treating posterior eye disease like age related macular degeneration by simple instillation (i.e. topical eyedrops) is not persuasive as Moon does explicitly teaches treating posterior eye conditions like age-related macular degeneration with the claimed compound from 0.01-10% in the pharmaceutical composition like eyedrops. It is noted that the argument is also not commensurate in scope with the instant claims. As for the assertion that Moon teaches injection to be preferred, that is not persuasive as while injection is preferred, the teachings of Moon are not held solely to the preferred embodiment when the general teaching is for a specific finite grouping of modes of administration which include eyedrops which is also expressly claimed. The assertion that there is no data for the topical administration in Moon is an argument for exemplification/anticipation which is not the bar for obviousness. Moon teaches treatment of eye conditions like age-related macular degeneration with the claimed active in known means like eyedrops, wherein there is a teaching for a reasonable expectation of success. The assertion that there is not a reasonable expectation of success for topical administration of the active is confusing as Applicant as arguing for nonenablement of the instant claims, it is also an argument against the breath claimed which is topical administration of the active for any and all eye diseases as written.
The argument that Beringer et al. is teaching for an ideal pH of 7.4 in ophthalmic formulation is merely an ideal target which is not a teaching the range of 3.5-8.5, is not persuasive as Beringer establishes the ideal pH for ophthalmic compositions wherein it is prima facie obvious to formulate the pH of the eye composition to be about 7.4 which falls within the instant claimed range and to optimize the pH to attain the desired therapeutic profile with a reasonable expectation of success.
As for the assertion that Table 8 demonstrates that the eyedrop has greater concentration of the active in the vitreous in the pH range of 3.5-8.5 than the comparative formulation and that Moon et al. and Beringer et al. does not disclose or suggest a correlation between pH and the active to effectively reach the posterior of the eye to improve drug delivery to the posterior of the eye; this is fully considered but not persuasive. The formulations in Table 8 are not commensurate in scope with the instant claims and does not disclose which buffers or concentration of buffer used in the examples, and contrary to Applicant’s assertion - Moon et al. expressly teaches treating age-related macular degeneration with the administration of the active with eyedrops – wherein the active is taught to treat the posterior segment of the eye with eyedrop administration wherein it is effective to address/reach the posterior segment of the eye, along with the inclusion of buffers and solubilizers.
As for the argument that Moon et al. and Beringer et al. do not disclose or suggest a correlation between pH and the active to effectively reach the posterior of the eye, this is not persuasive as the Examiner has a different reason for combining than the Applicant and the fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
As for the assertion that there is no motivation to combine the references, this is not persuasive as Beringer et al. is presented merely to show the known ideal pH and known solubilizers for eye formulations wherein it would be prima facie obvious to formulate the pH of the eye composition to be at the ideal pH with known solubilizers like polysorbates with a reasonable expectation of success.
Accordingly, the rejection stands.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. (KR101821593) in view of Beringer et al. (Ophthalmic Preparation -Buffer and pH, Additives) as applied to claims 2-3, 5-6, 17-22 above, further in view of Rowe (Polyoxyethylene Sorbitan Fatty Acid Esters).
Rejection:
The teachings of Moon et al. in view of Beringer et al. are addressed above.
Moon et al. in view of Beringer et al. does not expressly teach the amount of solubilizer but does teach the inclusion of solubilizers/surfactants like polysorbates.
Rowe et al. teaches that polysorbates are known solubilizers/surfactants which are conventionally used in ranges like 1-15% of a formulation (Table IV, Section 6).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the solubilizer/surfactant like polysorbates from 1-15% as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to formulated the solubilizer like polysorbate in their known range with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to Moon et al. and Beringer et al. which are addressed above.
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 2-3, 5-6, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-8 of U.S. Patent No. 11174240 in view of Moon et al. (KR101821593) and of Beringer et al. (Ophthalmic Preparation -Buffer and pH, Additives).
The patented claims 4-5 are directed a method of treating diseases including age-related macular degenerations with the administration of a crystalline
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to a patient in need thereof. Patented claims 6-7 are directed to a pharmaceutical composition comprising crystalline
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with additives including water, mineral oil (solvent/solubilizer), calcium phosphate (a buffer), and mixtures thereof; and in forms like an eyedrop and injection/solution.
While the patented claims to the method of treatment do not recite the additives and the patented claims to the composition does not recited the condition to be treated or the amount of active in the composition; Moon et al. teaches that this compound can be from 0.01-10% in a composition comprising with solubilizers and buffers in forms like eyedrops and known to be useful for the treatment of age-related macular degeneration, and Beringer et al. teaches that ophthalmic formulations should ideally be formulated at a pH equivalent to the tear fluid of 7.4 (Buffers and pH 1st paragraph) to minimize irritation, and that common additives include mineral oil and surfactants like polysorbate 80 (a polyoxyethylene sorbitan fatty acid ester) which are used to aid in solubilization and stabilize drugs (solubilizers, Additives 4th paragraph).
Wherein it would be prima facie obvious to use the patented composition for treating conditions it is known to be useful for, and it is also prima facie obvious for the patented claims for the method with the drug to incorporate the drug in formulations with additives like solubilizers and pH regulators/buffers that are taught for administrating the drug for the recited treatment with a reasonable expectation of success; and to formulate the pH at the ideal 7.4 in combination with known additives like polysorbate (a polyoxyethylene sorbitan fatty acid ester) with a reasonable expectation of success. It would also be prima facie obvious to optimize within the taught range for the amount of the active and attain the instant claimed values and a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments are to Moon et al. and Beringer et al. which is addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-8 of U.S. Patent No. 11174240 in view of Moon et al. (KR101821593) and of Beringer et al. (Ophthalmic Preparation -Buffer and pH, Additives) as applied to claims 2-3, 5-6, 17-22 above, further in view of Rowe (Polyoxyethylene Sorbitan Fatty Acid Esters).
The teachings of the patented claims in view of Moon et al. and Beringer et al. are addressed above.
The patented claims in view of Moon et al. and Beringer et al. do not expressly teach the amount of solubilizer but does teach the inclusion of solubilizers/surfactants like polysorbates.
Rowe et al. teaches that polysorbates are known solubilizers/surfactants/wetting agents which are conventionally used in ranges like 1-15% of a formulation (Table IV, Section 6).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the solubilizer/surfactant like polysorbates from 1-15% as suggested by Rowe et al. and produce the claimed invention; as it is prima facie obvious to have the solubilizer/polysorbate in their known useful range with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are directed to the patented claims (in view of Moon et al. and Beringer et al.) which is addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 2-3, 5-6, 8-9, 17-22 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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