DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 6, 11-15, 20-30, 32, 45 and 81 are pending as of the preliminary claim amendments submitted 7/17/2024. Claims 2-5, 7-10, 16-19, 31, 33-44 and 46-80 are cancelled. Claims 1, 6, 11-15, 20-30, 32, 45 and 81 are examined herein.
In view of the pending claims, the following rejections are made, as detailed below.
Priority
This application is a CON of 17/879,627 filed 08/02/2022 PAT 11873279, which is a CON of PCT/US2021/016414 filed 02/03/2021, which claims benefit to provisional applications PRO 63/010,212 filed 04/15/2020 and PRO 62/971,002 filed 02/06/2020.
Information Disclosure Statement
The information disclosure statement submitted on 12/04/2023 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Claims 1, 6, 11, 26-27, 32, 45, 81 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.
Regarding claims 1, 6, 11 and 32, the claims recite “Form 4” in parentheses. The presence of limitations in parentheses renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claim are unclear.
For the purpose of applying prior art, claims 1, 6, 11 and 32 have been interpreted to read “an anhydrous crystalline form, Form 4” without the parentheses and a comma in between.
Regarding claims 45 and 81, the claims recite “Form 1”, “Form 2”, “Form 3” (claim 45) and “Form 2” (claim 81) in parentheses. The presence of limitations in parentheses renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claim are unclear.
For the purpose of applying prior art, claim 45 has been interpreted to read “an anhydrous crystalline form, Form 1”; read “a monohydrate crystalline form, Form 2” and “an anhydrous crystalline form, Form 3” respectively, without the parentheses and a comma in between. Claim 81 has been interpreted to read “a monohydrate crystalline form, Form 2” without the parentheses and a comma in between.
Regarding claim 26, the claim recites “wherein the composition further comprises a therapeutically effective amount of an intra-ocular pressure (IOP) reducing agent, or a pharmaceutically acceptable salt thereof, wherein the IOP reducing agent is selected from the group consisting of prostaglandins (such as latanoprost or travoprost), beta-blockers (such as timolol or betaxolol), alpha adrenergic agonists (such as brimonidine, apraclonidine), carbonic anhydrase inhibitors (such as dorzolamide or brinzolamide), Rho kinase inhibitors (such as netarsudil) and miotic or cholinergic agents (such as pilocarpine)”, with a lot of limitations recited in parentheses (as highlighted). The presence of limitations in parentheses renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claim are unclear.
For the purpose of applying prior art, claim 26 has been interpreted without all “such as” limitations that appear in parentheses – i.e., all limitations in parenthesis are struck off from the claims.
Regarding claim 27, the claim recites “wherein the composition further comprises a therapeutically effective amount of a neuroprotective agent, or a pharmaceutically acceptable salt thereof, wherein the neuroprotective agent is selected from the group consisting of anti-apoptotic agents (such as caspase-2 inhibitor) and neurotrophic factors (such as ciliary neurotrophic factor)” with limitations recited in parentheses (as highlighted). The presence of limitations in parentheses renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claim are unclear.
For the purpose of applying prior art, claim 27 has been interpreted without all “such as” limitations that appear in parentheses – i.e., all limitations in parenthesis are struck off from the claims.
Claim Rejections - 35 USC § 112
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 12-15 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.
Regarding claims 12-13, the claims depend from claim 11 and recite “wherein the anhydrous crystalline Form 4 has the following characteristic peaks expressed in terms of diffraction angles (2θ)”. “Form 4” is the most specific recitation of the crystal form and will inherently exhibit the recited X-ray powder diffraction peaks. This is not considered as further limiting the scope of claim 11, which is improper.
Regarding claim 14, the claim depends from claim 11 and recites “wherein the anhydrous crystalline Form 4 has a Tm of about 163 °C by differential scanning calorimetry (DSC) analysis”. “Form 4” is the most specific recitation of the crystal form and will inherently exhibit the recited differential scanning calorimetry (DSC) property. This is not considered as further limiting the scope of claim 11, which is improper.
Regarding claim 15, the claim depends from claim 11 and recites “wherein the anhydrous crystalline Form 4 has a solubility of about 138 µg/mL at about pH 7 in a phosphate buffer”. “Form 4” is the most specific recitation of the crystal form and will inherently exhibit the recited solubility property at the stated pH. This is not considered as further limiting the scope of claim 11, which is improper.
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.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process... may obtain a patent therefor..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of U.S. Patent No. 11,873,279 B2.
The instant claim and the claim 1 of the reference ‘279 patent are drawn to a solid form of a compound of Formula I, characterized by identical X-ray powder diffraction peaks. Both set of claims are drawn to almost identical claim language.
The instant claims are drawn to
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The claims of the reference ‘279 patent are drawn to
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This is a statutory double patenting rejection.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 6, 11-15 and 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,873,279 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to an anhydrous crystalline form, Form 4 of a compound of Formula I, for use in the treatment of an ocular condition.
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The instant claims are drawn to an anhydrous crystalline form, Form 4 of a compound of Formula I, having an X-ray powder diffraction pattern comprising at least three characterization peaks, in terms of 2θ, selected from peaks at 5.640.2°, 11.4+0.2°, 17.740.2°, 19.340.2°, 21.1+0.2°, and 21.940.2° and methods of treating an ocular disease, comprising contacting an optical tissue in a subject with a composition containing a therapeutically effective amount of the anhydrous crystalline form, Form 4.
The claims of the reference ‘279 patent are drawn to a solid form of a compound of Formula I: wherein said compound is an anhydrous crystalline form, having an X-ray powder diffraction pattern comprising at least three characterization peaks, in terms of diffraction angle (2θ), wherein the peaks are selected from 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°.
The crystalline form of the reference ‘279 patent anticipates the anhydrous crystalline form, Form 4 of a compound of Formula I of the instant claims. Looking into the patent description for the utility of the crystalline form of the compound of Formula I, the compound is taught to be useful in methods of treating an ocular disease selected from glaucoma, diabetic retinopathy (DR), retinal vein occlusion (RVO), and retinopathy of prematurity (ROP) (Col. 3, Lns. 6-10).
Claims 1-7 of the reference ‘279 patent anticipate the instant claims 6, 11-15 and 20-23, drawn to a composition and method of treatment of ocular diseases using the anhydrous crystalline form, Form 4.
Thus, claims 1-7 of the reference ‘279 patent and instant claims 6, 11-15 and 20-23 are not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1, 6 and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40 and 51 of co-pending Application No 18/494,545.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to an anhydrous crystalline form, Form 4 of a compound of Formula I, for use in the treatment of an ocular condition.
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The instant claims are drawn to an anhydrous crystalline form, Form 4 of a compound of Formula I, having an X-ray powder diffraction pattern comprising at least three characterization peaks, in terms of 2θ, selected from peaks at 5.640.2°, 11.4+0.2°, 17.740.2°, 19.340.2°, 21.1+0.2°, and 21.940.2° and methods of treating an ocular disease, comprising contacting an optical tissue in a subject with a composition containing a therapeutically effective amount of the anhydrous crystalline form, Form 4.
The claims of the co-pending Application No 18/494,545 are drawn to a method for preventing, treating, or ameliorating a neovascular age-related macular degeneration (an ocular condition) in a subject in need thereof, comprising contacting an optical tissue in a subject with a composition comprising a therapeutically effective amount of a compound of Formula I, wherein the compound of Formula I is an anhydrous crystalline form (Form 4), having an X- ray powder diffraction pattern comprising at least three characterization peaks, in terms of 2θ, selected from peaks at 5.6+0.2°, 11.4+0.2°, 17.740.2°, 19.340.2°, 21.1+0.2°, and 21.9+0.2°.
The anhydrous crystalline form, Form 4 of the compound of Formula I of the reference ‘545 application anticipates the compound/composition of instant claims 1 and 6. The method claims 40 and 51 of the reference ‘545 application, that teaches administration of the anhydrous crystalline form, Form 4 to an optical tissue in a subject in the treatment of ocular diseases renders the instant method claims 11-13, prima facie obvious.
Thus, claims 40 and 51 of co-pending application 18/494,545 and instant claims 1, 6 and 11-13 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The crystalline forms of a compound of Formula I - anhydrous crystalline form, Form 4; an anhydrous crystalline form, Form 1; a monohydrate crystalline form, Form 2; an anhydrous crystalline form, Form 3, has been found to be free of prior art. Except for the 35 U.S.C. 112(b), 35 U.S.C. 112(d) and statutory/nonstatutory double patenting rejections discussed above, all claims would be allowable.
Claims 24-25 and 28-30 are objected to as being dependent from a rejected base claim.
Conclusion
Claims 1, 6, 11-15, 20-23, 26-27, 32, 45 and 81 are rejected.
Claim 24-25 and 28-30 is objected to.
No claims are allowed.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627