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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the syringe with a floating seal and a shunt coupled to the needle must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 59 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Specification reasonably describes a shunt placement system comprising an implantation syringe barrel with a floating seal, needle base, and needle. The Specification also reasonably describes and implantable shunt. However, the Specification does not describe in how the shunt is releasably coupled to the needle of the implantation syringe barrel.
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.
Claims 1, 2, 4, 35, 37, are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0354245 to Horvath in view of US 2023/0181358 to Khaderi et al.
In the specification and figures, Horvath discloses the method substantially as claimed by Applicant. With regard to claims 1, 2, 4, 35, 37, Horvath discloses an ab externo method for placing a shunt in the eye comprising inserting a needle into an eye, delivering a flowable material through the needle to form a bleb 212 that may be formed in a subconjunctival or suprachoroidal space, (see FIG 12, ¶0293, 0296-0297), positioning an inflow end of an implant 230 (which may be impregnated with a drug) in an anterior chamber of an eye, and an outflow end in the bleb, and releasing a needle 222 with a pusher rod 232 from implant 230 (see FIGS 12-15, ¶0388).
Horvath does not disclose using the same needle for fluid delivery and shunt implantation. However, Khaderi discloses a method of shunt implantation with the use of a fluid expander that is injected prior, during, or after shunt deployment in order to create or augment a drainage space, suggesting that the same needle comprises both fluid media and a shunt (see ¶0164). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to add a fluid as suggested by Khaderi to the shunt implantation method and device disclosed by Horvath, in order to create or augment a drainage space within the eye, as taught by Khaderi.
Claims 1, 5-8, 11, 36, 37, 39, 47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0361484 to Ianchulev in view of US 2023/0181358 to Khaderi et al.
In the specification and figures, Ianchulev discloses the method substantially as claimed by Applicant. With regard to claims 1, 5-8, 11, 36, 37, 39, 47 Ianchulev discloses an ab interno method for placing a shunt in an eye comprising inserting a needle 210 into the eye, positioning an end of an implant 105 (which may comprise a drug) into the anterior chamber, a second end into a suprachoroidal space, releasing the implant from the lumen of delivery device via an actuator, thereby creating a flow path (see ¶0006, 0068-0069, 0082, 0164).
Ianchulev does not disclose the step of dilating a space before implant delivery. However, Khaderi discloses a method of shunt implantation along with the use of a fluid expander that is injected prior, during, or after stent deployment in order to create or augment a drainage space (see ¶0164). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to add a step of bleb dilation as taught by Khaderi to the shunt implantation method disclosed by Ianchulev, in order to create or augment a drainage space within the eye, as taught by Khaderi.
Claim 59, as best understood by the Examiner, is rejected under 35 U.S.C. 103 as being unpatentable over US 8,142,403 to Carlyon in view of US 9,301,875 to Tu et al.
In the specification and figures,9Carlyon discloses a system for placing media in a patient in a sequential fashion. With regard to claim 59 Carlyon discloses a syringe barrel 112, floating seal 150, needle base 130, a needle 142 that engages the base, a needle distal end 142a and opening with a needle body passageway, wherein the needle base advances the needle through the floating seal to to allow sequential delivery of discrete products in a single device (see Carlyon FIGS 5, 5A and column 4, line 59 to column 5, line 40). Tu discloses a syringe 116 with a needle 118 and distal space 122 for holding a stent device 30, but not a floating seal (see Tu FIG 31 and accompanying text). While Carlyon discloses sequential delivery of fluids, the construction of the Carlyon reference would allow for needle shunt delivery. It would have been obvious to a person with ordinary skill in the art at the time of filing to use a syringe with a floating seal in order to deliver a first liquid and a second substance to a desired location in a patient.
Allowable Subject Matter
Claims 18, 24, and 31 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.
Claims 40 and 49 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: With regard to claims 18, 24, 31, 40, the prior art fails to teach a positioning step wherein the needle is placed away from the anterior chamber angle in combination with the other steps and limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 24 November 2025