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 with traverse of 7/10/2025 in the reply filed on 7/10/2025 is acknowledged. The traversal is on the ground(s) that “because the invention of Group II is basically the same as that of Group I, and any prior art searched for one group is applicable to the other group. Hence, there would not be a serious search and/or examination burden.” This is not found persuasive because search burden is not a criteria for restriction under PCT Rule 13.1. The criteria for restriction is unity of invention. The groups lack unity of invention for the reasons set forth in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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 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 151-152, 154, 156, 171, and 185-186 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2019/050863 A1 to Radiance (document already in record). Radiance teaches a method of reducing intraocular pressure (Para (0059) "In some embodiments, the method is effective for reducing intraocular pressure (IOP)") in an eye being treated or having been treated with (i) glaucoma drainage surgery wherein an implant is implanted trans-sclerally to form a bleb in a subconjunctival space or between the conjunctiva and Tenon's capsule and aqueous humor can drain into the drainage bleb (Para (0058) " the beta radiation is effective for maintaining function of the bleb to allow the MIGS implant to drain aqueous humor from the anterior chamber of the eye"), and said method comprising applying a therapeutic amount of beta radiation from a radioisotope to a target area of the eye (Figure 10 and Para [0081) FIG. 10 shows a schematic view of the planning treatment volume of the bleb, wherein a therapeutic dose is applied throughout the width and depth of the target", the bleb is a target area of the eye), wherein the target area is associated with the bleb, the implant, or both the bleb and implant (Figure 10 and Para [0081)" FIG. 10 shows a schematic view of the planning treatment volume of the bleb, wherein a therapeutic dose is applied throughout the width and depth of the target"); wherein the therapeutic amount of beta radiation helps maintain a functioning drainage bleb (Para [0058) "the beta radiation is effective for maintaining function of the bleb to allow the MIGS implant to drain aqueous humor from the anterior chamber of the eye"), but does not disclose comprising (ii) cataract surgery. However, Radiance discloses the need for investigation of combining cataract surgery with beat radiation treatment (Para (0035) "The randomized controlled clinical trial results revealed a notable increased incidence of cataracts associated with beta therapy; and the Kirwan authors called for an "urgent study ... of combined surgery (trabeculectomy with beta radiation plus cataract extraction)"). It would have been obvious to one of skill in the art to identify a method comprising cataract surgery to manage cataracts by routine experimentation. Radiance further teaches a radioisotope that emits beta radiation (Para (0058) "a radioisotope that emits beta radiation") for use in a method, the method comprising: a. performing a glaucoma drainage surgery on an eye of a patient wherein an implant is implanted trans-sclerally to form a bleb in a subconjunctival space or between the conjunctiva and Tenon's capsule (Para [0058) "wherein the target is at least a portion of a bleb in the subconjunctival space of the eye or in a space between the conjunctiva and Tenon's capsule formed by a M!GS implant"), the glaucoma drainage surgery allows aqueous humor to drain into the bleb (Para (0058) "the beta radiation is effective for maintaining function of the bleb to allow the MIGS implant to drain aqueous humor from the anterior chamber of the eye"); and c, applying a therapeutic dose of the beta radiation from the radioisotope to a target area of the eye (Figure 10 and Para (0081)" F!G. 10 shows a schematic view of the planning treatment volume of the bleb, wherein a therapeutic dose is applied throughout the width and depth of the target", the bleb is a target area of the eye), wherein the target area is associated with the bleb, the implant, or both the bleb and implant (Figure 10 and Para (0081) "F!G. 10 shows a schematic view of the planning treatment volume of the bleb, wherein a therapeutic dose is applied throughout the width and depth of the target"); wherein the method is effective for lowering intraocular pressure (IOP) (Para [0059) "In some embodiments, the method is effective for reducing intraocular pressure (IOP)"), but does not disclose a method of treating both glaucoma and cataracts and performing cataract surgery. However, Radiance discloses the need for investigation of combining cataract surgery with beat radiation treatment (Para (0035] "The randomized controlled clinical trial results revealed a notable increased incidence of cataracts associated with beta therapy; and the Kirwan authors called for an "urgent study ... of combined surgery (trabeculectomy with beta radiation plus cataract extraction)"). Radiance further teaches the radioisotope according to claim 1 wherein the radioisotope comprises Strontium-90 (Sr-90), Phosphorus-32 (P 2), Ruthenium 106 (Ru-106), Yttrium 90 (Y-90), or a combination thereof (Para (0042) "In any of the methods or compositions here, the radioisotope or source of beta radiation may comprise Strontium-90 (Sr-90), Phosphorus-32 (P-32), Ruthenium 108 (Ru-106), Yttrium 90 (Y-90), or a combination thereof'), and further teaches a radiation dose of may be provided in a dose of 600 cGy to 1000 cGy (Para [00159).
This is a method of treating glaucoma and cataracts, said method comprising: a. performing a glaucoma drainage surgery in an eye, wherein an implant is implanted trans-sclerally to form a bleb in a subconjunctival space or between the conjunctiva and Tenon’s capsule and aqueous humor can drain into the drainage bleb; b. performing cataract surgery on the eye; and c. applying a therapeutic dose of the beta radiation from a radioisotope to a target area of the eye, wherein the target area is associated with the bleb, the implant, or both the bleb and implant; wherein the method is effective for one or a combination of: reducing intraocular pressure (IOP), maintaining a functioning drainage bleb; inhibiting or reducing fibrogenesis and inflammation in the bleb, around the drainage implant, or around the drainage channel; and reducing conjunctival inflammation in the eye, wherein the radioisotope comprises Strontium-90 (Sr-90), Phosphorus-32 (P-32), Ruthenium 106 (Ru-106), Yttrium 90 (Y-90), or a combination thereof; wherein the glaucoma drainage surgery is MIGS and the implant is a MIGS implant; and wherein the therapeutic dose is from 450-1050 cGy. Regarding the recitation “the method is effective for reducing IOP and subsequent stabilization of said IOP,” this is a property of the claimed method. As the method taught by Radiance is the same as the present method, the method taught by Radiance must have the same property as the claimed method, that is, be effective for reducing IOP and subsequent stabilization of said IOP.
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.
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 151-152, 154, 156, 160-163, 171, and 185-186 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/050863 A1 to Radiance (document already in record). The relevant portions of Radiance are given above.
Radiance fails to teach the order of beta radiation application required by claims 160-163.
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to optimize the order of beta radiation application to improve the efficacy of the method for treating glaucoma and cataracts, and in this way, find wherein the beta radiation is applied to the target after performing the glaucoma drainage surgery, wherein beta radiation is applied to the target before performing the glaucoma drainage surgery. wherein a beta radiation is applied to the target while performing the glaucoma drainage surgery, wherein beta radiation is applied to the target before and after performing the glaucoma drainage surgery, through routine experimentation. “’[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)” MPEP § 2144.05, II.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
October 18, 2025