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
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/11/26.
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.
Claim(s) 1-5, 12, 13, 15, AND 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US 2010/0256597) hereinafter Prausnitz in view of Oberkircher et al. (US 2021/0298951) hereinafter Oberkircher.
Regarding claim 1, Prausnitz teaches a method of delivering a therapeutic agent to the optic nerve head (ONH) of a subject, the method comprising:
creating a sclerostomy posterior to the limbus of the subject (refer to paragraph [0039]);
tunneling the catheter through the suprachoroidal space (SCS) toward the ONH;
disposing the needle tip (114) adjacent, or into, the ONH; and
injecting the therapeutic agent adjacent or into the ONH (Refer to paragraph [0029 and 0031]).
Prausnitz fails to explicitly teach feeding a catheter with a distal needle tip tangentially into the sclerostomy.
Oberkircher teaches creating a sclerostomy and feeding a catheter (20) with a distal needle tip (30) tangentially into the sclerostomy (refer to paragraph [0177]), and delivering a therapeutic agent (Refer to paragraph [0173]) to the sclera (this would result in the delivery to the ON, per Prautsnitz teachings).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to tangentially introduce a catheter with a needle tip to the suprachoirdal space in the method of Prausnitz as taught by Oberkircher to reduce the risk of trauma to the choroid (See paragraph [0177] of Oberkircher).
Regarding claim 2, modified Prausnitz teaches the sclerostomy is created from 1 to 5 mm posterior to the limbus (Refer to paragraph [0098] “microneedles were then inserted 5-7 mm posterior from the limbus).
Regarding claim 3, modified Prausnitz teaches the sclerostomy is created by inserting a hollow microneedle through the sclera (Refer to paragraph [0011]).
Regarding claim 4, modified Prausnitz teaches claim 3, wherein the length of the hollow microneedle is from 500 µm to 1.5 mm (Refer to paragraph [0062] “the microneedle has a length or effective length that does not exceed 2000 microns and a width (or diameter) that does not exceed 500 microns”)
Regarding claim 5, modified Prausnitz teaches wherein the hollow microneedle insertion angle is 50 to 60 degrees (Refer to paragraph [0068], the microneedle extends from the base at an angle from about 60 to about 90 degrees”).
Regarding claim 12, modified Prausnitz teaches the therapeutic agent is injected as a liquid formulation, a solid implant that elutes the therapeutic agent, or microparticles that elute the therapeutic agent (Refer to paragraph [0084]).
Regarding claim 13, modified Prausnitz teaches the subject has an optic neuropathy (glaucoma is a progressive optic neuropathy, refer to paragraph [0009, 0034]).
Regarding claim 15, modified Prausnitz teaches the subject has glaucoma (Refer to paragraph [0009, 0034]) or non-arteritic anterior ischemic optic neuropathy (NAION).
Regarding claim 16, modified Prausnitz teaches the therapeutic agent is a neurotrophic factor (Neucrosis factor, refer to paragraph [0082]).
Second interpretation:
Claim(s) 1,3, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2021/0298951) hereinafter Oberkircher in view of Prausnitz et al. (US 2010/0256597) hereinafter Prausnitz.
Regarding claim 1, Oberkircher teaches a method of delivering a therapeutic agent to the optic nerve head (ONH) of a subject, the method comprising:
creating a sclerostomy posterior to the limbus of the subject (refer to paragraph [0177);
creating a sclerostomy and feeding a catheter (20/420) with a distal needle tip (30/430) tangentially into the sclerostomy (refer to paragraph [0177]),
tunneling the catheter through the suprachoroidal space (SCS) toward the ONH;
disposing the needle tip (20) adjacent, or into, the ONH; and
injecting the therapeutic agent adjacent or into the ONH (Refer to paragraph [173]).
Oberkircher fails to explicitly teach delivering the therapeutic agent to optic nerve. Prautsnitz teaches that it is believed that upon entering the suprachoroidal space the fluid drug formulation flows circumferentially from the insertion site toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye (see paragraph [0031]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the method of Oberkircher to tangentially inject a therapeutic agent to the sclera, resulting in an injection of therapeutic agent adjacent or into the ONH as taught by PRautsnitz, this procedure would reduce the risk of trauma to the choroid (See paragraph [0177] of Oberkircher).
Regarding claim 3, Oberkircher teaches the sclerostomy is created by inserting a hollow microneedle through the sclera (Refer to paragraph [0011]).
Regarding claim 6, Oberkircher teaches passing the catheter (430) through the lumen of the hollow microneedle (420, See figure 21).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US 2010/0256597) hereinafter Prausnitz in view of Oberkircher et al. (US 2021/0298951) hereinafter Oberkircher, as applied to claim 3, above and further in view of Lynch et al. (US 20030055372) hereinafter Lynch.
Regarding claim 7, (dep. claim 3) modified Prausnitz fails to explicitly teach wherein prior to the feeding, a viscoelastic agent is injected into the SCS while the hollow microneedle is inserted through the sclera
Lynch teaches delivering a viscoelastic agent in the sclera to facilitate tunneling and lubricate the area (refer to paragraph [0112]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a viscoelastic agent prior to feeding as taught by Lynch to facilitate tunneling.
Claim(s) 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US 2010/0256597) hereinafter Prausnitz in view of Oberkircher et al. (US 2021/0298951) hereinafter Oberkircher, as applied to claim 3 above and further in view of Krueger et al. (US 20100189817) hereinafter Krueger.
Regarding claims 10, and 14, modified Prausnitz fails to explicitly teach the needle tip in the peripapillary SCS adjacent the ONH and the optic neuropathy is a glaucomatous optic neuropathy, ischemic optic neuropathy, autoimmune disease-associated optic neuropathy, optic disc drusen, toxic optic neuropathy, metabolic optic neuropathy, compressive optic neuropathy, Infiltrative optic neuropathy, traumatic optic neuropathy, or optic neuritis.
Krueger teaches administering a therapeutic agent in the peripapillary sclera, to treat an optic neuropathy such as glaucomatous optic neuropathy (refer to claim 1, and oaragraog [0030]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to inject a therapeutic agent in the peripapillary sclera, to treat glaucomatous optic nerve damage, with the method of modified Prausnitz, as taught by Krueger, for a targeted administration of drug to the patient.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US 2010/0256597) hereinafter Prausnitz in view of Oberkircher et al. (US 2021/0298951) hereinafter Oberkircher, as applied to claim 3 above and further in view of Cash et al. (WO 00/12006) hereinafter Cash.
Regarding claim 11, modified Prausnitz fails to explicitly teach the disposing comprises disposing the needle tip into the ONH, and wherein the therapeutic agent is injected into the ONH.
Cash teaches injecting the ONH with an agent to treat a tumor (refer to page 16, lines 5-10). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to inject the ONH using the method of modified Prausnitz, as taught by Cash, to treat a tumor.
Allowable Subject Matter
Claims 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The subject matter of the independent claims could either not be found or was not suggested in the prior art.
Regarding claim 8, the subject matter not found was the step of feeding the catheter tangential to the sclera at an angle from 25 to 35 degrees, in combination with the other elements in the claim.
Regarding claim 9, the subject matter not found was the step of the catheter including a sheath, and during feeding and tunneling the catheter and distal needle being covered with the sheath, and during injection the needle tip is unsheathed.
Thus, for at least the foregoing reasons, the prior art of record neither anticipates nor rendered obvious the present invention as set forth in the independent claim.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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