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 .
Election/Restrictions
Applicant’s election without traverse of Species A (claims 1-10) in the reply filed on 10/9/25 is acknowledged. Claims 11-20 are withdrawn from consideration.
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.
Claim(s) 1, 3-5, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burns et al. (US 20190083307).
Regarding claim 1, Burns et al. discloses a prosthetic tear duct system (device illustrated in fig. 1, in the specific embodiment where there is a one-way valve as described in par. 0052-0053, more than one retention protrusion in the form of flexible barbs as described in par. 0025, and a tubular lumen as described in par. 0064), comprising: a body 10 comprising first end portion and a second end portion (opposite ends of body 10), the body defining a longitudinal lumen 12 extending between the first and second end portions; one or more anchor members movably coupled to the body, each anchor member being selectively reconfigurable from a retracted position to a deployed position, wherein tip end portions of the one or more anchor members extend radially outward from an outer surface of the body when the one or more anchor members are in the deployed positions, and wherein, when the one or more anchor members are in the retracted positions, the one or more anchor members are each radially retracted in comparison to the deployed positions (flexible barbs, par. 0025; due to being flexible and being shaped as barbs, these elements are fully capable of being manipulated between the positions as claimed); and a one-way valve within the longitudinal lumen (par. 0052-0053).
Regarding claim 3, Burns et al. discloses the one-way valve is configured to allow passage of fluid through the longitudinal lumen in a first direction from the first end portion to the second end portion and to prevent fluid from passing through the longitudinal lumen in a second direction from the second end portion to the first end portion (par. 0052-0053, the valve is a one-way valve).
Regarding claim 4, Burns et al. discloses the one or more anchor members comprise a plurality of anchor barbs that are individually selectively reconfigurable from the retracted position to the deployed position (par. 0025 envisions one or more barbs; the barbs are flexible, and therefore fully capable of manipulation as claimed).
Regarding claim 5, Burns et al. discloses plurality of anchor barbs are individually selectively reconfigurable from the deployed position to the retracted position (par. 0025 envisions one or more barbs; the barbs are flexible, and therefore fully capable of manipulation as claimed).
Regarding claim 8, Burns et al. discloses the body is a cylindrical tube, an oval tube, a conical tube, a curved tube, or a polygon prism (tubular passageway, par. 0064).
Regarding claim 10, Burns et al. discloses the first end portion of the body of the prosthetic tear duct apparatus comprises a flange 14.
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) 2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Avery et al. (US 5725493).
Regarding claim 2, Burns et al. discloses the system as claimed, including a one-way valve, but fails to specify any specific type of one-way valve, such as the claimed options of a shut-off valve, a ball-and-spring-valve, a compression stop valve, a compression stop valve, swing check valve, tilting disc check valve, reed valve, diaphragm check valve, or a duckbill valve. However, Avery et al. illustrates a couple of known types of one-way valves are known for use in ocular applications, including a duckbill valve 268 and a ball-and-spring-valve (270, 272, 254; see fig. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize either a duckbill valve or a ball-and-spring valve, as taught by Avery et al., as the one-way valve of Burns et al., since such a modification is a simple substitution of one known element (one of the valve types of Avery et al.) for another (generic one-way valve of Burns et al) to achieve a predictable result (one-way valve functionality required by Burns et al.).
Regarding claim 7, Burns et al. discloses the system as claimed, except for specifically disclosing a valve-housing unit comprising the one-way valve within the longitudinal lumen. However, Avery et al. teaches a ball-and-spring valve (270, 272, 254), which is a type of one-way valve, in fig. 10, which utilizes a valve housing 254 as part of the valving mechanism. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a ball-and-spring valve with a valve housing, as taught by Avery et al., as the one-way valve of Burns et al., since such a modification is a simple substitution of one known element (type of one-way valve of Avery et al.) for another (generic one-way valve of Burns et al) to achieve a predictable result (one-way valve functionality required by Burns et al.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Han (WO 2021101080).
Regarding claim 6, Burns et al. discloses the system as claimed, except for a tool configured for manual reconfiguration of the plurality of anchor barbs between the deployed positions and the retracted positions. However, Han teaches utilizing a tool (injector) which manipulates the anchor barbs between positions (pg. 6, 3rd full paragraph of the English translation). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a tool as taught by Han in the system of Burns et al. in order to provide sufficient structure to orient the barbs in a position to allow implantation and orient the barbs into a different position for retention, as taught by Han (pg. 6, 3rd full paragraph of the English translation).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al. in view of Toharski et al. (US 20120157938).
Regarding claim 9, Burns et al. discloses the system as claimed, including disclosing that alternative lumen shapes are acceptable (par. 0064), except for specifically disclosing the longitudinal lumen has an hourglass shape. However, Toharski et al. teaches, in a similar device, utilizing a lumen with an hourglass shape 9see fig. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize an hourglass shaped lumen, as taught by Toharski et al., as opposed to a tubular shaped lumen of Burns et al., since such a modification is a simple substitution of one known element (hourglass lumen) for another (generic tubular lumen of any shape) to achieve a predictable result (providing a lumen through the device).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783