DETAILED ACTION
Claims 1-2, 4, 7-8, 12-13, 17-24, 35-39 are pending. Claims 12-13, 23-24 and 38 are currently under examination.
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 .
Election/Restrictions
Applicant’s election of Group II (claims 4, 12-13, 23-24 and 38) in the reply filed on 02/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 7-8, 17-22, 35-37 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Applicant’s election of 127-130 degrees C and mixing hydrogenated 40 polyoxyl castor oil and octoxynol-40 in the reply filed on 02/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/11/2026.
Priority
The instant application is a national stage entry of PCT/IB2022/057851, filed 08/22/2022, which claims priority to IN202121037917, filed 08/20/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 05/28/2024, 12/30/2024, 01/02/2025, 05/19/2025 and 02/11/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Rejections - 35 USC § 112 (b)
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 13 is 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.
Claim 13 contains the limitation (deg.) in regards to the 2-theta. The use of parenthesis makes it unclear if the limitation if required or optional, thus leading to unclear metes and bounds of the instant claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,918,694 (IDS dated 05/28/2024) in view of US 2020/0237859 (IDS dated 02/11/2026).
Regarding claim 1, the limitation of a method of making a stable nanomicellar ophthalmic formulation comprising cyclosporine, hydrogenated 40 polyoxy castor oil, ocyoxynol-40 and an aqueous vehicle wherein the method comprises a) mixing the hydrogenated 40-polyoxyl castor oil and the octoxynyol-40 at a temperature to form a mixture A, adding cyclosporine at the mixture A at a temperature and mixing the resulting mixture with the aqueous vehicle at a temperature is met by the ‘694 patent teaches topical ophthalmic formulation containing cyclosporine (abstract) which is taught to be exceptionally stable and used in large scale manufacturing (column 1, lines 45-60). The formulation contains nanomicelles and is stable at high temperatures above 40 degrees C (column 2, lines 5-15). The polyoxy castor oil is taught to be HCO-40 and the polyoxyl lipid or fatty acid is octoxynol 40 (column 2, lines 45-30). The process of melting polyoxyl lipid, slowly adding cyclosporine and homogenizing the mixture and adding polyalkoxylated alcohol of step (2) in continued stirring until a uniform homogeneous solution is obtained and adding to water (column 9, lines 5-15) wherein the HCO-40 is melted and heated to about 60 degrees C (column 9, lines 40-50, example 4).
Regarding claim 23, the limitation of wherein the formulation comprises 0.09 wt% of the cyclosporine, about 1.0 wt% of the hydrogenated 40 polyoxyl castor oil and about 0.05 wt% of the octoxynol-40 is met by the ‘694 patent teaching the formulation comprises 0.093 wt% of the cyclosporine, about 1.0 wt% of the hydrogenated 40 polyoxyl castor oil and about 0.05 wt% of the octoxynol-40 (claim 1).
Regarding claim 24, the limitation of about 0.20-0.55 wt% sodium phosphate monobasic, about 0.23-0.465 wt% sodium phosphate dibasic, about 0.05 wt% sodium chloride, about 0.3 wt% povidone and sodium hydroxide and/or hydrochloric acid is met by the ‘694 publication teaching about 0.20-0.405 wt% sodium phosphate monobasic, about 0.23-0.465 wt% sodium phosphate dibasic, about 0.05 wt% sodium chloride, about 0.3 wt% povidone and sodium hydroxide and/or hydrochloric acid (claim 1).
The ’694 patent does not specifically teach 127-130 ° C (claim 12).
The ‘859 publication teaches aqueous suspensions of cyclosporin in a dispersing agent to treat ophthalmic disorders (abstract). Dissolving cyclosporin is taught wherein the solvent is solid at room temperature, these solvents are heated to a temperature sufficient to melt the solid and then the cyclosporine is dissolved in the liquid form of the solvent. Suitable temperatures for predation of the compristion are determined by routine experiment [0132]. Autoclaving of the composition is taught to be at 121 degrees C [0141] and teaches the dispersing to be a high temperature [0154]. Mixing parameters such as speed of mixing, shear, temperature, etc. are optimized for each compristion to yield the desired properties [0172].
The ‘694 patent specifically teaches the process of melting polyoxyl lipid, slowly adding cyclosporine and homogenizing the mixture and adding polyalkoxylated alcohol of step (2) in continued stirring until a uniform homogeneous solution renders the instant claims obvious as MPEP 2144.049 IV (C) renders the order of steps obvious. This is further supported by the final mixture to comprise a homogenous blend of the three claimed ingredients. Ex parte Rubin , 128 USPQ See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (; In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). MPEP 2144.049 IV (C)
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the temperature at which the micelles were formed as the ‘694 patent teaches heating, melting and mixing the components of the cyclosporine, the hydrogenated 40 polyoxyl castor oil and the octoxynol-40 wherein the heating is at about 60 degrees C and the ‘859 publication teaches melting excipients to mix with cyclosporine at high temperature wherein the temperature is taught to be an optimizable parameter. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the processing temperature of the ‘694 patent to obtain the desired micelle compristion as the ‘859 publication temperature is a known optimizable parameter. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘859 patent teaches that it was known to subject compositions including cyclosporine to temperatures of 121 degrees C, thus providing an expectation of success in using the claimed temperature range in compositions including cyclosporin. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,918,694 in view of US 2020/0237859 as applied to claims 12 and 23-24 above, and further in view of CEQUA cyclosporine ophthalmic solution FDA labeling information (IDS dated 02/11/2026).
As mentioned in the above 103 rejection, all the limitations of claims 12 and 23-24 are taught by the combination of the ’694 patent and the ’859 publication.
The combination of references does not specifically teach wherein the osmolality of the formation is about 150 toa bout 200 mOsmol/kg (claim 38).
The ‘694 patent teaches embodiments of the formulation with osmolality adjusted to be in the range of about 250-350 mOsmol/kg, however also states more broadly that “…tonicity agents may be used to adjust the osmolality of the compositions.” (page 8, column 15, lines 49-52), and that “…osmolality adjusted in accordance with well-known techniques to proper physiological values.” (page 8, column 15, lines 40-42), wherein a pharmaceutical additive can be added to a composition of the present disclosure to adjust the osmolality of the composition, such as sugars (page 8, column 15, lines 59-66). CEQUA cyclosporine ophthalmic solution FDA labeling information directly teaches a 0.09 wt % orthorhombic cyclosporine formulation with an osmolality of 160-190 mOsmol/kg and a pH of 6.5-7.2 containing all the same excipients (page 4, figure and first paragraph).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the osmolarity limitations of the instant claims to the invention of the ‘694 patent, given it was known in the art at the time of the invention to use this hypotonic osmolality range in the formulation of commercially available CEQUA cyclosporine ophthalmic solution per FDA labeling information and the ‘694 patent teaches osmolality to be an optimizable parameter through the tonicity agents used. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,918,694 in view of US 2020/0237859 as applied to claims 12 and 23-24 above, and further in view of US 2013/0023482 (IDS dated 02/11/2026).
As mentioned in the above 103 rejection, all the limitations of claims 12 and 23-24 are taught by the combination of the ’694 patent and the ’859 publication.
The combination of references does not specifically teach the specific cyclosporine form.
The ‘482 publication teaches the cyclosporine A (CsA) is known to exist in an amorphous form, liquid crystal form, tetragonal crystalline form (Form 1), an orthorhombic form (Form 3) (¶[0011]; Figure 1) and in dihydrate cyclosporine solvate forms (e.g., cyclosporine A • 2H₂O; ¶[0029]-[0030]), and that the forms can be isolated from one another for use (see claim 1 and 2 only using form 2). Thus, the choice of specific known crystalline cyclosporine A polymorphs (e.g., orthorhombic cyclosporine A form 1 and/or amorphous forms or mixtures thereof) that correspond to a specific characterized X-ray diffraction (XRD) peak 2-theta angles of cyclosporine (¶[0025] and claim 2; Figure 1) and the exclusion of other specific polymorphs or hydrates (e.g., cyclosporine A form 2 and tetragonal form 3 and/or cyclosporine A dihydrate) would be a matter of formulation choice to ensure the desired solubility, stability, and dissolution rate of the drug product. One would be motivated to choose the instant claimed polymorph forms with these peaks providing enhanced stability in an aqueous solution and improved bioavailability (i.e., lower crystallinity amorphous forms can significantly improve the poor water solubility and dissolution rate of cyclosporine to improve absorption- e.g., Neoral® versus Sandimmune®).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to choose the specific known amorphous form or polymorph form or mixture thereof of cyclosporine in the invention of the ‘943 patent, because these forms were known at the time of the invention to be used for the same purpose and are obvious to optimize for achieving stable micelles based on routine experimentation (see In re Aller, 220 F.2d 454 (CCPA 1955)).
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 12-13, 23-24 and 38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-20 of copending Application No. 18/683,943 (reference application) in view of US 2020/0237859. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘943 application teaches a method of making a nanomicelluar ophthalmic formulation comprising cyclosporine, hydrogenated 40 polyoxyl castor oil, octoxynol- 40, sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, povidone and sodium hydroxide in overlapping amounts comprising mixing at elevated temperatures cyclosporine and hydrogenated 40 polyoxylcastor oil, mixing with octoxynol-40 and adding water to result in a nanomicellar ophthalmic formulation. The instant application differs in that hydrogenated 40 polyoxyl castor oil and octoxyno-40 are mixed at a temperature of 127-130 degrees to form a mixture before addition of cyclosporine and water at 127-130 degrees C.
The ‘859 publication teaches aqueous suspensions of cyclosporin in a dispersing agent to treat ophthalmic disorders (abstract). Dissolving cyclosporin is taught wherein the solvent is solid at room temperature, these solvents are heated to a temperature sufficient to melt the solid and then the cyclosporine is dissolved in the liquid form of the solvent. Suitable temperatures for predation of the compristion are determined by routine experiment [0132]. Autoclaving of the composition is taught to be at 121 degrees C [0141] and teaches the dispersing to be a thigh temperature [0154]. Mixing parameters such as speed of mixing, shear, temperature, etc. are optimized for each compristion to yield the desired properties [0172].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the temperature at which the micelles were formed as the ‘943 application teaches heating, melting and mixing the components of the cyclosporine, the hydrogenated 40 polyoxyl castor oil and the octoxynol-40 wherein the heating is at about 55 degrees C and the ‘859 publication teaches melting excipients to mix with cyclosporine at high temperature wherein the temperature is taught to be an optimizable parameter. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the processing temperature of the ‘943 application to obtain the desired micelle compristion as the ‘859 publication temperature is a known optimizable parameter. Regarding the order of steps, the ‘943 application teaches the final mixture to comprise a blend of the three claimed ingredients. Ex parte Rubin , 128 USPQ See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (; In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). MPEP 2144.049 IV (C)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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