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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/IB2021/058488 filed 09/17/2021, which claims the benefit of the priority of United Kingdom Patent Application No. GB2014740.1 filed 09/18/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 03/17/2023, 04/19/2023 and 10/25/2024 have been considered by the examiner.
Claim Status
Claims 1-14, 16-17, 20-22, and 24 are pending. Claims 15, 18-19, 23, and 25-28 are canceled. Claims 1-14, 16-17, 20-22, and 24 are being examined on the merits in this office action.
Claim Objections
Claims 1 and 17 is objected to because of the following informalities:
Claim 1 should be amended to recite: “….in a subject suffering from a disorder associated…”
Claim 17 recites “…once or twice a daily…”. The claim should be amended to recite “…once or twice a day…”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-7, 12-14, 16-17, 20-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2013/0303436A1 – hereinafter “Wilson”) as evidenced by Dikopf et al. (Expert Opin Pharmacother. 2017 Jun; 18 (9): 885–898) in view of Hernandez et al. (Diabetes 2016;65:172–187).
Wilson teaches a method of treating a disease or condition comprising administering a therapeutically effective amount of the composition comprising GLP-1 alone or in combination with one or more active agents, wherein the disease or condition is an ophthalmic disease or condition such as glaucoma and further exemplifies glaucoma as the condition being treated (claim 1, 3, 5; [0009-0013, 0255-0256]) and further teaches that Glaucoma patients typically have an intraocular pressure in excess of 21 mm Hg [0259]. Wilson teaches that glucagon-like peptide-1 (GLP-1) polypeptide and/or naturally occurring or artificial variants or analogues of GLP-1, including but not limited to GLP-1 (7-36) amide and GLP-1 (7-37) [0036, 0308].
Wilson does not explicitly teach that IOP is being reduced, and does not teach the dose as recited in claim 16.
However, Wilson teaches the patient population (i.e. subjects with a condition associated with IOP such as glaucoma) and teaches the active ingredient (i.e. GLP-1 receptor agonist). Further, as evidenced by Dikopf, current treatments of glaucoma aim to reduce IOP and that the treatments lower IOP (See Abstract). Thus, Examiner concludes that the reduction of IOP is an expected result of treating the disease/condition glaucoma.
Regarding the dose, Hernandez teaches topical administration of GLP-1 as eye drops to prevents retinal neurodegeneration (abstract). Hernandez teaches that topical administration of liraglutide was administered at a dose of 80 µ, lixisenatide (20 mg/kg/day; 5 mL/eye twice) (n = 6), and exenatide (40 mg/kg/day; 5 mL/eye twice) were also tested in order to assess their effectiveness in preventing retinal neurodegeneration (page 174, right col. 2nd paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Wilson and administer GLP-1 receptor agonist to reduce IOP since it is known in the art as evidenced by Dikopf, that treating glaucoma reduces IOP. Further, Examiner notes the limitation of “reducing IOP” constitutes an intended result of an active method step or a process step actively recited. It would have been obvious to one of ordinary skill in the art to topically administer GLP-1 at the recited dose since it was more effective (page 180, right col., last paragraph).
One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the method of Wilson to reduce IOP since treatment of the instant condition glaucoma reduces IOP. Further, since Wilson teaches the use of the instant GLP-1 receptor agonist to treat conditions such as glaucoma associated with high IOP, the limitation “reducing IOP” constitutes an intended result of the method step. Further as evidenced by Dikopf, treating glaucoma results in a decrease of IOP. The disclosures render obvious claim 1.
Regarding claim 2, Wilson teaches that Glaucoma patients typically have an intraocular pressure in excess of 21 mm Hg [0259].
Regarding claims 3-4, Wilson teaches a method of treating a disease or condition comprising administering a therapeutically effective amount of the composition comprising GLP-1 alone or in combination with one or more active agents, wherein the disease or condition is an ophthalmic disease or condition such as glaucoma and further exemplifies glaucoma as the condition being treated (claim 1, 3, 5; [0009-0013, 0255-0256]). However, Wilson does not explicitly teach the types of glaucoma recited in claim 3. However, as evidenced by Dikopf topical treatment of glaucoma such as open angle glaucoma, which is the most common type of glaucoma (Introduction section; Page 9 2nd paragraph). One of ordinary skill in the art would be motivated to use the method of Wilson on the different types of glaucoma such as open angle glaucoma which is the most common type glaucoma.
Regarding claim 5, Wilson teaches that glucagon-like peptide-1 (GLP-1) polypeptide and/or naturally occurring or artificial variants or analogues of GLP-1, including but not limited to GLP-1 (7-36) amide and GLP-1 (7-37) [0036, 0308].
Regarding claims 6-7, Wilson teaches that an example of a naturally occurring DPP IV-resistant GLP-1 analogue is exendin-4 [0007].
Regarding claims 12-14, Wilson teaches that GLP-1 can be administered intravenously, orally, topically, intranasally, intramuscularly, subcutaneously, or transdermally [0315-0316]. Further, Hernandez teaches topical administration of native GLP-1 and several GLP-1R agonists (liraglutide, lixisenatide, and exenatide (Abstract).
Regarding claim 16, Hernandez teaches that topical administration of liraglutide was administered at a dose including 80 µg, in order to assess their effectiveness in preventing retinal neurodegeneration (page 174, right col. 2nd paragraph). It would have been obvious to one of ordinary skill in the art to topically administer GLP-1 at the recited dose since it was more effective (page 180, right col., last paragraph).
Regarding claim 17, Wilson teaches that GLP-1 can be administered once per day, twice per day [0301].
Regarding claim 20, Wilson teaches that GLP-1 can be administered in combination with one or more active agents such as adrenergic beta-2 agonist, adrenergic beta-1 antagonist [0372-0374].
Regarding claim 21, Hernandez teaches that glucagon-like peptide 1 (GLP-1) exerts neuroprotective effects in the central nervous system and the retina (Abstract). It would have been obvious to modify Wilson and use GLP-1 to provide neuroprotective effects since Hernandez teaches that topically administered native GLP-1 and several GLP-1R agonists (liraglutide, lixisenatide, and exenatide provided neuroprotective effects (Abstract).
Regarding claim 22, Wilson teaches that the subject is a human [0134, 0313].
Regarding claim 24, Wilson teaches the GLP-1 is in composition mixed with a suitable pharmaceutical carrier (vehicle) or excipient such as milk, sugar, certain types of clay, gelatin, lactic acid, stearic acid or salts thereof, including magnesium or calcium stearate, talc, vegetable fats or oils, gums and glycols [0319-0320].
Claims 1-13, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Canonge et al. (US20190134030A1– hereinafter “Canonge”) as evidenced by Dikopf et al. (Expert Opin Pharmacother. 2017 Jun; 18 (9): 885–898) in view of Heijl et al. (Arch Ophthalmol. 2002;120; (10): 1268-1279).
Canonge teaches a method of eye treatment comprising administering a compound selected from the group consisting of mammal GLP-1, particularly human GLP-1, liraglutide, exenatide, lixisenatide, its salts and mixtures thereof [0070-0075], that the composition for topical administration to the eye [0076], that the composition is for treatment of eye disorders such as glaucoma (claim 4, 12, 18-19 [0003, 0059, 0094]).
Canonge does not explicitly teach that IOP is being reduced, but Canonge teaches the patient population (i.e. subjects with a condition associated with IOP such as glaucoma) and teaches the active ingredient (i.e. GLP-1 receptor agonist). Further, as evidenced by Dikopf, current treatments of glaucoma aim to reduce IOP and that the treatments lower IOP (See Abstract).
Canonge does not teach wherein the method comprises determining baseline IOP of the subject.
However, it is known in the art that the treatment of glaucoma comprises establishing a baseline IOP and comparing the IOP values after treatment as taught by Heijl.
Heijl teaches the treatment of glaucoma, wherein the treatment leads to reduction of IOP (Title; Abstract). Heijl teaches determining a baseline IOP and teaches monitoring the change in IOP from the baseline after treatment (See page 1271, left col., last paragraph, and whole of right paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Canonge and determine the baseline IOP of the subject prior to treatment so as to compare the effect of the therapy as taught by Heijl. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in establishing a baseline IOP before treatment so as to compare the effect of immediate therapy to lower the IOP. Disclosures render obvious claim 1.
Regarding claim 2, Heijl teaches that elevated IOP is known to be in glaucoma subjects (Abstract; Page 1276, left col. Last paragraph). Further, Dikopf teaches that Primary-open angle glaucoma (POAG), the most common type of glaucoma and includes elevated intraocular pressure (IOP) (Page 2, 2nd paragraph). It would have been obvious to treat IOP in glaucoma subjects wherein the IOP is elevated since it is known that subjects with glaucoma have an elevated IOP.
Regarding claims 3-4, Heijl teaches types of glaucoma including open angle glaucoma (Abstract). Further, Dikopf teaches several types of glaucoma including open angle glaucoma (Page 14, line 3). It would have been obvious to treat IOP in open angle glaucoma subjects since it is known that subjects with glaucoma have an elevated IOP (Page 2, 2nd paragraph).
Regarding claims 5-7, Canonge teaches a method of eye treatment comprising administering a compound selected from the group consisting of mammal GLP-1, particularly human GLP-1, liraglutide, exenatide, lixisenatide, its salts and mixtures thereof [0070-0075].
Regarding claims 8-11, Canonge teaches administering the instant GLP-1 receptor agonist to the instant patient population. Further, Heijl teaches the treatment of glaucoma, wherein the treatment leads to reduction of IOP (Title; Abstract). Heijl teaches determining a baseline IOP and teaches monitoring the change in IOP from the baseline after treatment (See page 1271, left col., last paragraph, and whole of right paragraph). Heijl teaches that treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Canonge and determine the baseline IOP of the subject prior to treatment so as to compare the effect of the therapy as taught by Heijl. In addition, with regards to the recitation of “wherein the GLP-1 receptor agonist reduces IOP in the subject by at least 5%”, Examiner notes that the limitation recites an intended result. The claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the method step of claim 1 and is given little patentable weight.
Regarding claims 12-13, Canonge teaches a method of eye treatment comprising administering a compound selected from the group consisting of mammal GLP-1, particularly human GLP-1, liraglutide, exenatide, lixisenatide, its salts and mixtures thereof [0070-0075], that the composition for topical administration to the eye [0023, 0076].
Regarding claim 21, Cononge teaches GLP-1 exerts neuroprotective effects in both the central and peripheral nervous systems [0071].
Regarding claim 24, Canonge teaches compositions in combination with excipients [0069-0079].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654