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 .
DETAILED ACTION
Status of Claims
Claims 1-20 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6, 10-13, and 17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2023/0026451 (hereafter, HUGHES; cited in the IDS filed on 6/10/2025).
HUGHES teaches a method of reducing intraocular pressure (IOP) or treating glaucoma in a patient, comprising the step of placing a biodegradable intraocular implant in an eye of the patient, the implant comprising a prostamide and a biodegradable polymer matrix that releases drug at a rate effective to sustain release of an amount of the prostamide from the implant to provide an amount of the prostamide effective to prevent or reduce a symptom of the ocular condition of the eye, wherein said prostamide is bimatoprost (prostaglandin F2α) and administering is done by at least one of intravitreal injection, subconjuctival injection, sub-tenon injection, retrobulbar injection, and suprachoroidal injection (abstract, [0030], [0032], [0057], [0082], and [0083]). The administration method does not include supraciliary injection.
HUGHES further teaches that the biodegradable polymer includes methylcellulose (pharmaceutically acceptable excipient) ([0033]).
HUGHES discloses that an implant may comprise bimatoprost, and the matrix of the implant degrades at a rate effective to sustain release of a therapeutically effective amount of bimatoprost for about one month (30 days) after being placed in an eye and in another example, the implant may comprise bimatoprost, and the matrix releases drug at a rate effective to sustain release of a therapeutically effective amount of bimatoprost for more than forty days, such as for about six months ([0057]).
HUGHES specifically discloses that the IOP of a dog treated with the high-release bimatoprost intracameral implant described in Example 1 was reduced to approximately −60% from baseline and such reduction was sustained for at least 5 months ([0011] and Fig. 5). Also, HUGHES discloses that the IOP of a dog treated with the low-release bimatoprost intracameral implant described in Example 2 was reduced to approximately −40% from baseline and such reduction was sustained for at least 42 days (Fig. 7 and [0013]).
As to the limitation, “the IOP is reduced by at least 20% for a period of 30-60 days following the suprachoroidal injection” in claim 11, the limitation is an intended result of the active method step and as such are non-limiting since the language does not result in manipulative difference in steps of claim 1. HUGHES teach the same method step as instantly claimed (i.e. administering the pharmaceutical composition comprising the same active ingredient by suprachoroidal injection as claimed), thus such intended result necessarily occurs. It should be noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims are anticipated by HUGHES.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0190359 (hereafter, Venkatraman; cited in the IDS filed on (6/10/2025) and US 2013/0216606 (hereafter, Venkatraman’606) in view of US 2023/0026451 (hereafter, HUGHES; cited in the IDS filed on 6/10/2025) in further view of Wan et al. (Pharmaceutics, 13, 288, 2021).
Venkatraman teaches a stable liposomal formulation for ocular delivery containing a liposome that includes at least one lipid bilayer containing a phosphatidylcholine, and a prostaglandin F2α encapsulated in the liposome and a method for treating an ocular disorder such as ocular hypertension or glaucoma with the formulation (abstract and claims 1 and 9-10). Venkatraman further teaches that prostaglandin F2α is latanoprost, bimatoprost, travoprost, or carboprost (claim 3). Venkatraman also teaches that the phosphatidylcholine is palmitoyl oleoyl phosphatidyl choline (POPC) (claim 2).
Venkatraman specifically discloses latanoprost-loaded POPC liposomes wherein latanoprost (2 mg/ml stock solution in acetonitrile) was added to the lipid solvent mixture at a drug:lipid mole ratio of 0.175:1 and a latanoprost liposomal formulation (100 µl) having an initial drug/lipid mole ratio of 0.175:1 was introduced by subconjunctival injection into both eyes of three animals (Examples 2 and 4). Venkatraman further discloses that over a 28-day period, approximately 65% of the latanoprost was released from the latanoprost-loaded POPC liposomes in a time-dependent manner ([0028]). Venkatraman further discloses that administering the liposomal formulation results in a reduction in IOP of at least 30% (e.g., 30%, 40%, and 50%) compared to the pretreatment IOP and the IOP remains reduced for as long as 4-6 months following a single injection ([0022]).
Venkatraman’606 teaches a liposomal formulation for ocular delivery containing a liposome that includes at least one lipid bilayer containing a phosphatidylcholine and a prostaglandin F2α encapsulated in the liposome, wherein the phosphatidylcholine is egg phosphatidylcholines (EPC) and a method for treating an ocular disorder such as ocular hypertension or glaucoma with the formulation (abstract and claims 1 and 33-34). Venkatraman’606 further teaches that prostaglandin F2α is latanoprost, bimatoprost, travoprost, or carboprost ([0052] and claim 12).
Venkatraman’606 specifically discloses latanoprost-loaded EPC liposomes wherein latanoprost (2 mg/ml stock solution in acetonitrile) was added to the lipid solvent mixture at a drug:lipid mole ratio of 0.154:1 and the final latanoprost concentration in EggPC liposomes after extrusion is estimated to be greater than 1 mg/ml ([0079] and [0105]). Venkatraman’606 further discloses the latanoprost liposomal formulation (0.1 ml) was introduced by subconjunctival injection into each eye ([0096]). Venkatraman’606 also discloses that at 30 days IOP reduces by 3.0 ± 0.17 mmHg in group B treated with the subconjunctival latanoprost-loaded liposome from the baseline IOP 13.6 ± 0.3 mmHg (at least 20 % reduction) ([0182] and Fig 12).
Venkatraman or Venkatraman’606 does not specifically teach suprachoroidal injection.
However, it was known in the art that a sustained release formulation comprising prostaglandin F2α such as bimatoprost can be administered by suprachoroidal injection as well as subconjuctival injection in the treatment of ocular hypertension or glaucoma as evidenced by HUGHES (abstract, [0030], [0032], [0057], [0082], and [0083]). The administration method does not include supraciliary injection.
In addition, Wan et al. disclose that there remain significant unmet clinical needs in other ocular disorders, such as glaucoma, that are currently treated topically with eye drops and/or surgery (p1, last para-p2, para 1). Wan et al. further disclose that glaucoma patients face challenges including compliance with proper administration of topical eye drops of beta blockers (e.g., timolol), alpha agonists (e.g., brimonidine), Rho kinase inhibitors (e.g., netarsudil), and prostaglandin analogs (e.g., latanoprost) (p2, para 1). Wan et al. teach and suggest that drug delivery to the suprachoroidal space (SCS) has unique potential advantages in that (1) it specifically targets affected chorioretinal tissues with posterior and circumferential spread of the drug administered, (2) it may provide sustained drug kinetic release profiles, depending on the physio-chemical formulation properties, and (3) it may spare the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects to potentiate safety (p2, para 3). In addition, Wan et al. disclose preclinical and clinical investigations of small molecules in polymeric formulations administered into the suprachoroidal space for treating various ocular conditions including glaucoma (p8, Table 2). Wan et al. suggest that this SC administration may further play a significant role in ocular drug delivery of additional novel therapeutic agents for a wide range of ocular diseases, spanning from glaucoma and ocular melanoma to various common chorioretinal diseases, such as age-related macular degeneration and diabetic retinopathy (p3, para 1-2, and Fig. 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the liposomal formulation of Venkatraman or Venkatraman’606 via suprachoroidal injection for treating ocular hypertension or glaucoma because suprachoroidal injection was taught be suitable administration route for treating the same conditions as evidenced by HUGHES and Wan et al. The skilled artisan would have been motivated to do so on the reasonable expectation that administering the same formulation via suprachoroidal injection would result in similar outcomes in the treatment of the same ocular condition as administering it via subconjunctival injection while providing sustained drug kinetic release profiles and minimizing risks associated with off-target effects to potentiate safety as taught by Wan et al.
As to the limitation, “the IOP is reduced by at least 20% for a period of 30-60 days following the suprachoroidal injection” in claim 11, the limitation is intended results of the active method step and as such are non-limiting since the language does not result in manipulative difference in steps of claim 1. The references in combination teach, suggest and motivate the same method step as instantly claimed (i.e. administering the pharmaceutical composition comprising the same active ingredient via the same route as claimed), thus such intended result necessarily occurs when the composition of Venkatraman or Venkatraman’606 is administered into an eye of a subject via the suprachoroidal injection as taught and modified by HUGHES. In the alternative, Venkatraman already discloses that administering the liposomal formulation by subconjunctival injection results in a reduction in IOP of at least 30% (e.g., 30%, 40%, and 50%) compared to the pretreatment IOP and the IOP remains reduced for as long as 4-6 months following a single injection ([0022]). Thus, one of ordinary skill in the art would have reasonably expected similar effects following the suprachoroidal injection.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
Claims 1-2, 6-9, 12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gabelt et al. (Journal of Ocular Pharmacology and therapeutics, 25 (1):1-8, 2009after, cited in the IDS filed on 6/10/2025) in view of US 2023/0026451 (hereafter, HUGHES; cited in the IDS filed on 6/10/2025) in further view of Wan et al. (Pharmaceutics, 13, 288, 2021).
Gabelt et al. teach a formulation comprising a prostaglandin F2α such as latanoprost, bimatoprost, or travoprost for reducing intraocular pressure (IOP) and antiglaucoma therapy (abstract). Gabelt et al. disclose that stock solutions of the study agents such as latanoprost, bimatoprost, and travoprost were prepared in 100 % dimethyl sulfoxide and treatment solutions were formulated in 20% DMSO/PBS and was given as two 5 µl drops (10 µl) administered to the central cornea of the supine (p2, col 1, para 2-3). Gabelt et al. specifically discloses the clinical doses of latanoprost (1.5 µg), bimatoprost (9 µg) and travoprost (1.2 µg) were equally effective in significantly lowering IOP by approximately 25% from hours 12-20 following the fourth treatment (p2, col 2, para 3). Thus, the prior art discloses the solution comprises 1.5 µg latanoprost in 10 µl of 20% DMSO/PBS, which is converted to 0.015% w/v (0.015 g/100 ml). The concentrations of DMSO and latanoprost fall within the range recited in claim 8-9 and 19-20.
Gabelt et al. do not specifically teach suprachoroidal injection.
However, it was known in the art that a formulation comprising prostaglandin F2α such as bimatoprost can be administered to the suprachoroidal space by suprachoroidal injection as well as to the conjunctiva, the subconjunctival space, or the intracorneal space in the treatment of ocular hypertension or glaucoma as evidenced by HUGHES (abstract, [0027], [0030], [0032], [0057], [0082], and [0083]). The administration method does not include supraciliary injection.
In addition, Wan et al. disclose that there remain significant unmet clinical needs in other ocular disorders, such as glaucoma, that are currently treated topically with eye drops and/or surgery (p1, last para-p2, para 1). Wan et al. further disclose that glaucoma patients face challenges including compliance with proper administration of topical eye drops of beta blockers (e.g., timolol), alpha agonists (e.g., brimonidine), Rho kinase inhibitors (e.g., netarsudil), and prostaglandin analogs (e.g., latanoprost) (p2, para 1). Wan et al. teach and suggest that drug delivery to the suprachoroidal space (SCS) has unique potential advantages in that (1) it specifically targets affected chorioretinal tissues with posterior and circumferential spread of the drug administered, (2) it may provide sustained drug kinetic release profiles, depending on the physio-chemical formulation properties, and (3) it may spare the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects to potentiate safety (p2, para 3). Wan et al. disclose preclinical and clinical investigations of small molecules in polymeric formulations administered into the suprachoroidal space for treating various ocular conditions including glaucoma (p8, Table 2). Wan et al. suggest that this SC administration may further play a significant role in ocular drug delivery of additional novel therapeutic agents for a wide range of ocular diseases, spanning from glaucoma and ocular melanoma to various common chorioretinal diseases, such as age-related macular degeneration and diabetic retinopathy (p3, para 1-2, and Fig. 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the formulation of Gabelt et al. to the suprachoroidal space via suprachoroidal injection for treating ocular hypertension or glaucoma because administrating the same prostaglandin F2α via suprachoroidal injection was taught be suitable administration route for treating the same conditions as evidenced by HUGHES and Wan et al. The skilled artisan would have been motivated to do so on the reasonable expectation that administering the same formulation via suprachoroidal injection would result in similar outcomes in the treatment of the same ocular condition as administering it to central corneal in the absence to the contrary while providing sustained drug kinetic release profiles and minimizing risks associated with off-target effects to potentiate safety as taught by Wan et al.
Double Patenting Rejections
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 1-6 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US patent 9,956,195 in view of US 2023/0026451 (hereafter, HUGHES) and Wan et al. (Pharmaceutics, 13, 288, 2021).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘195 patent are drawn to a method of treating ocular hypertension or glaucoma comprising administering a stable liposomal formulation for ocular delivery comprising a liposome formed of palmitoyl oleoyl phosphatidyl choline (POPC), and latanoprost encapsulated in the liposome, wherein the dependent claims further recites the formulation is administered via subconjunctival injection.
The claims of the patent do not specifically recite suprachoroidal injection. However, it was known in the art that a sustained release formulation comprising prostaglandin F2α such as bimatoprost can be administered by suprachoroidal injection as well as subconjuctival injection in the treatment of ocular hypertension or glaucoma as evidenced by HUGHES (abstract, [0030], [0032], [0057], [0082], and [0083]). In addition, Wan et al. disclose that there remain significant unmet clinical needs in other ocular disorders, such as glaucoma, that are currently treated topically with eye drops and/or surgery (p1, last para-p2, para 1). Wan et al. further disclose that glaucoma patients face challenges including compliance with proper administration of topical eye drops of beta blockers (e.g., timolol), alpha agonists (e.g., brimonidine), Rho kinase inhibitors (e.g., netarsudil), and prostaglandin analogs (e.g., latanoprost) (p2, para 1). Wan et al. teach and suggest that drug delivery to the suprachoroidal space (SCS) has unique potential advantages in that (1) it specifically targets affected chorioretinal tissues with posterior and circumferential spread of the drug administered, (2) it may provide sustained drug kinetic release profiles, depending on the physio-chemical formulation properties, and (3) it may spare the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects to potentiate safety (p2, para 3). Wan et al. disclose preclinical and clinical investigations of small molecules in polymeric formulations administered into the suprachoroidal space for treating various ocular conditions including glaucoma (p8, Table 2). Wan et al. suggest that this SC administration may further play a significant role in ocular drug delivery of additional novel therapeutic agents for a wide range of ocular diseases, spanning from glaucoma and ocular melanoma to various common chorioretinal diseases, such as age-related macular degeneration and diabetic retinopathy (p3, para 1-2, and Fig. 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the liposomal formulation of the patent via suprachoroidal injection for treating ocular hypertension or glaucoma because suprachoroidal injection was taught be suitable administration route for treating the same conditions as evidenced by HUGHES and Wan et al. The skilled artisan would have been motivated to do so on the reasonable expectation that administering the same formulation via suprachoroidal injection would result in similar outcomes in the treatment of the same ocular condition as administering it via subconjunctival injection in the absence to the contrary while providing sustained drug kinetic release profiles and minimizing risks associated with off-target effects to potentiate safety as taught by Wan et al.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
