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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/792,377
This office action is in response to the original claims of 08/01/2024.
Claims 1-30 are examined on merit.
Priority
The effective filing date is 02/02/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
No IDS was found as of 06/09/2026
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.
Claims 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over
LOFTSSON THORSTEINN (WO-2021001366-A1, publication date is 07/01/2021)
In view of
Chang; Chin-Ming (US-6969706-B1).
In further view of
Anisel et.al. (PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS) 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Claims are drawn to ophthalmic composition of dexamethasone
LOFTSSON THORSTEINN in (page 19 lines 19-34 and page 20) teaches a microsuspension of ophthalmic composition with pH between 4 and 6(claims 1 and 16) comprising of
1 to 4% of dexamethasone, for example 1.5% to 3% of dexamethasone; (and teaching claims 1-2 and 16)
1 to 35% of y-cyclodextrin, for example 5 to 25% of γ-cyclodextrin; (teaching claims 1, 3 and 16)
2.2 to 2.8% of polymer, or 2.8 to 3.2%, for example 2.5% or 3.0% of polymer, poloxamer (teaching claims 6-9 and 18-21)
0 to 0.2% of stabilizing agent, for example 0.1 % of stabilizing agent, typically, disodium edetate; (teaching claims 1, 10-11 and 16)
0.15 to 0.45% of an additive to prevent the oxidation of the corticosteroid, for example between 0.2% and 0.4%, or between 0.2% and 0.3%, of an additive to prevent the oxidation of the corticosteroid, typically phenolic antioxidants or reducing agents, such as water-soluble natural antioxidants, and more preferably sodium thiosulfate;(teaching claims 1,12-14, 16 and 22)
0 to 1 % of electrolyte, for example 0.57% of electrolyte, typically sodium chloride; (claims 1 and 15-16) and
water; wherein the % are % by weight based on the volume of the composition.
Partially teaching claims 1 and 16
LOFTSSON THORSTEINN in page 25 (line further teaches use of the composition for retinal disease (claim 23)
diabetic macular edema; (claim 26)
inflammation following ocular surgery, typically following cataract surgery (claims 29-30)
Chang et.al teaches an ophthalmic composition with, from 0.6 to1.8% prednisolone acetate, from 10% to 25% hydroxypropyl-γ-cyclodextrin, from 0% to 0.25% hydroxypropylmethylcellulose, from 3 to 10 ppm PHMB, from 0% to 0.1 % EDTA disodium (claims 1, 10-11 and 16), 0.05%- 0.6 % sorbic acids (preservative,teaching claims 1, 4-5, and 16 ), with pH from 4.5-5.5 (column 8 lines 5-21) teaching pH of claims 1 and 16.
2. Ascertaining the differences between the prior art and the claims at issue.
Although LOFTSSON THORSTEINN teaches the ophthalmic composition with dexamethasone, Loftsson does not each the use of sorbic acid in the composition.
Although Chang teaches the ophthalmic composition with sorbic acid, Chang does not each the use of dexamethasone in the composition.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing ophthalmic composition and looking into extending shelf-life of the ophthalmic composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use the ophthalmic composition of dexamethasone in (Loftsson et.al. page 19 lines 19-34 and page 20) with sorbic acid to increase the shelf-life of the formulation, because sorbic acid is used as preservative in the composition of ophthalmic composition in Chang et.al (column 8 lines 5-21). Adding sorbic acid to an ophthalmic composition of dexamethasone (Loftsson et.al. page 19 lines 19-34 and page 20) is expected to increase its shelf-life. Therefore, it would be obvious for a person skilled in the art to combine the teaching of Loftsson (WO-2021001366-A1, publication date is 07/01/2021) with Chang et.al. to develop a composition of dexamethasone of claims 1 and 16.
Moreover, Loftsson teaches the composition to be used in treating retinal diseases including diabetic macular edema; (claim 26) and inflammation following ocular surgery, typically following cataract surgery (claims 29-30) (Loftosson, page 25). Therefore, it would be obvious for a person skilled in the art to develop a method of treating diabetic macular edema; (claim 226) and inflammation following ocular surgery, typically following cataract surgery (claims 29-30). Furthermore, it would be obvious for a person skilled in the art to treat any retinal diseases, such as age-related macular degeneration (claim 24), diabetes retinopathy (claim 25), retinopathy of prematurity (claim 27), and pathologic choroidal neo vascularization (claim 28) with corticosteroid, such as dexamethasone in an ophthalmic compositions.
Claims 1-13 and 16-22 are directed to concentration of different compounds in the ophthalmic composition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages which examiner interpret as of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
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 1-30 are rejected on the ground of nonstatutory double patenting as being obvious over claims 1-14, 19, 21-23 and 26-27 of U.S. Patent No. 12,097,209 B2
In view of
Chang; Chin-Ming (US-6969706-B1).
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Claims are drawn to ophthalmic composition of dexamethasone and its use for treating retinal diseases.
Reference claims 1-12, 19, and 21-23 teaches an ophthalmic composition with pH between 4 and 6(reference claims 14 and 23 same as instant claims 1 and 16)
1 to 4% of dexamethasone, for example 1.5% to 3% of dexamethasone; reference claims 1-2 and 19 same as instant claims 1-2 and 16)
5 to 25% of γ-cyclodextrin, for example 5 to 25% of γ-cyclodextrin; (reference claims1,3 and 19 same as instant claim 3)
2.2 to 2.8% of polymer, poloxamer (reference claim 1, 4-6 same instant claims 6-8 and 18-20)
0 to 0.2% of stabilizing agent, for example 0.1 % of stabilizing agent, typically, disodium edetate; reference claims 1, 7 and 19 same as instant claims 1, 10-11 and 16)
0.1 to 0.5% sodium thiosulfate; reference claims 1, 7, 11-12,19 and 21-22 same instant claims 1, 14, 16 and 22)
0 to 1 % of electrolyte, sodium chloride; (reference claims 1, 10, 11-12,19 and 21-22 teaching claims 1, 14, 16 and 22 same as instant claims 1 and 15-16) and
water; wherein the % are % by weight based on the volume of the composition.
Partially teaching claims 1 and 16
Reference claims 16-17 and 26-27 method of treating retinal disease same as reference claim 23
diabetic macular edema; reference claims16-17 and 26-27 same as instant c claim 26)
Chang et.al teaches an ophthalmic composition with, from 0.6 to1.8% prednisolone acetate, from 10% to 25% hydroxypropyl-γ-cyclodextrin, from 0% to 0.25% hydroxypropylmethylcellulose, from 3 to 10 ppm PHMB, from 0% to 0.1 % EDTA disodium (claims 1, 10-11 and 16), 0.05%- 0.6 % sorbic acids (preservative,teaching claims 1, 4-5, and 16 ), with pH from 4.5-5.5 (column 8 lines 5-21) teaching pH of claims 1 and 16.
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference claims teaches the ophthalmic composition with dexamethasone, Reference claims does not each the use of sorbic acid in the composition.
Although Chang teaches the ophthalmic composition with sorbic acid, Chang does not each the use of dexamethasone in the composition.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing ophthalmic composition and looking into extending shelf-life of the ophthalmic composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to use the ophthalmic composition of dexamethasone in reference claims 1-14, 19, 21-23 with sorbic acid to increase the shelf-life of the formulation, because sorbic acid is used as preservative in the composition of ophthalmic composition in Chang et.al (column 8 lines 5-21) Adding sorbic acid to an ophthalmic composition of dexamethasone (reference claims 1-14, 19, 21-23) is expected to increase its shelf-life of the ophthalmic composition. Therefore, it would be obvious for a person skilled in that to combine the teaching of reference claims 1-14, 19, 21-23 publication with Chang et.al. to develop a composition of dexamethasone of claims 1 and 16.
Moreover, reference claims 16-17 and 26-27 teaches the composition to be used in treating retinal diseases including diabetic macular edema; (claim 26) Therefore, it would be obvious for a person skilled in the art to develop a method of treating diabetic macular edema (claim 26). Furthermore, it would be obvious for a person skilled in the art to treat any retinal diseases, such as, age related macular degeneration (claim 24), diabetes retinopathy (claim 25), retinopathy of prematrurity (claim 27), pathologic choroidal neo vascularization (claim 28) and inflammation following ocular surgery, following cataract surgery (claims 29-30) with corticosteroid, such as dexamethasone in an ophthalmic compositions.
Claims 1-13 and 16-22 are directed to concentration of different compounds in the ophthalmic composition. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages which examiner interpret as of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here 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 experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Conclusion
No claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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