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 .
Response to Amendment
The claims have been amended on July 30, 2026, following the restriction requirement from June 1, 2026. Claim 36 which was the sole claim in group 2 has been canceled as a result the restriction is now moot.
Claims 1-18 and 56-57 are currently pending. Claims 19 and 36 were cancelled. Claims 56-57 are newly added. Claims 20-35 and 37-55 were canceled prior to examination.
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.
(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.
Claim(s) 1-2, 4-7, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schieber US 2017/0360609 A9 (hereafter referred to as Schieber-2017).
With regards to claim 1, Schieber-2017 discloses an ocular implant (abstract), comprising: a tubular body extending in a curved configuration and configured to lower an intraocular pressure of an eye when implanted within Schlemm's canal of the eye, wherein a longitudinal axis of the tubular body forms an arc, wherein the tubular body comprises: a distal portion and a proximal portion, a plurality of openings disposed in between the distal portion and the proximal portion, and a plurality of tissue supporting frames and spines connecting the tissue supporting frames, wherein each of the openings is surrounded by at least one of the tissue supporting frames )[0087-0089] which discloses the ocular implant is placed in Schlemm’s canal to reduce ocular pressure and has frames and spines and opening and is curved, fig 2 and 23);
and a leading tip (or core 12166, fig 23) coupled to the distal portion of the tubular body, wherein the leading tip is configured to guide the tubular body into Schlemm's canal ((because the core fits inside the tubular body it is couple to it and [0166] notes the core guides the tubular body into Schlemm’s canal).
With regards to claim 2, Schieber-2017 discloses wherein the leading tip comprises a tip distal segment and a tip proximal segment, wherein the leading tip is tapered such that a diameter or width of the leading tip along the tip proximal segment is greater than the diameter or width of the leading tip along the tip distal segment ([0162] which notes the core is tapered).
With regards to claim 4, Schieber-2017 discloses wherein the leading tip has a tip distal end, and wherein the tip distal end is rounded with no sharp edges to ensure that the tip distal end does not damage tissue within the eye when the leading tip is advanced into Schlemm's canal (fig 23 shows and rounded tip for the core 12166 and [0162] notes the core tappers, [0166 notes the core is used to guide the implant into Schlemm’s canal).
With regards to claim 5, Schieber-2017 discloses wherein the leading tip is detachably coupled to the tubular body such that the leading tip is removable after at least part of the tubular body is implanted within Schlemm's canal ([0166] notes the core is removed from the tubular body once in place).
With regards to claim 6, Schieber-2017 discloses wherein the tubular body comprises an aperture defined at the distal portion, and wherein at least part of the leading tip extends through the aperture to allow the leading tip to be detachably coupled to the tubular body (fig 23, which shows and aperture through which the core extends though and is able to be detachably coupled, [0166]).
With regards to claim 7, Schieber-2017 discloses wherein the tissue supporting frames and the spines of the tubular body define a lumen extending therethrough ([0086-0088)], and wherein the leading tip is configured to be retracted through the lumen after the leading tip is detached from the tubular body ([0166]).
With regards to claim 18, Schieber-2017 discloses wherein the leading tip is flexible such that the leading tip conforms to a curvature of Schlemm's canal when advanced into Schlemm's canal (fig 23, which shows the core follows the cure of the body).
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.
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) 3, 15-17, and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Schieber US 2017/0360609 A9 (hereafter referred to as Schieber-2017).
With regards to claim 3, Schieber-2017 fails to disclose wherein a diameter or width of the leading tip along the tip proximal segment is between about 250 pm to about 300 pm, and wherein a diameter or width of the leading tip along the tip distal segment is between about 100 pm to about 200 pm.
However, Schieber’s tubular structure is entering the same space Schlemm’s canal has applicant’s therefore it would have been obvious to one of ordinary skill in the art before the effective filling date to have made the core (i.e. leading tip) structure to not only be small enough to fit inside the same specific anatomical location but also to fit within the tubular body which it resides in. (MPEP 2144.05 II. A.)
With regards to claim 15, Schieber-2017 fails to disclose wherein the tubular body has a body length, wherein the leading tip has a tip length, and wherein a ratio of the tip length to the body length is between 1:1.1 and 1:1.6.
However Schieber’s tubular structure plus core is entering the same space Schlemm’s canal has applicant’s therefore it would have been obvious to one of ordinary skill in the art before the effective filling date to have made the core (i.e. leading tip) structure to a at least the same length if not a little short than the tubular body in order to help guide the structure in place. (MPEP 2144.05 II. A.)
With regards to claim 16, Schieber-2017 fails to disclose wherein the leading tip has a maximum diameter or maximum width, and wherein a length-to-diameter aspect ratio of the tip length to the maximum diameter or maximum width of the leading tip is between 20:1 and 30:1.
However, Schieber’s tubular structure is entering the same space Schlemm’s canal has applicant’s therefore it would have been obvious to one of ordinary skill in the art before the effective filling date to have made the adjusted the length to diameter of the core (i.e. leading tip) structure to not only be small enough to fit inside the same specific anatomical location but also to fit within the tubular body which it resides in. (MPEP 2144.05 II. A.)
With regards to claim 17, Schieber-2017 fails to disclose wherein the leading tip is dyed a color to allow the leading tip to be seen when advancing into Schlemm's canal, and wherein the color is at least one of red, green, blue, yellow, orange, and purple.
Adding a color to improve contrast and to allow for better part distinction is well known as such it would have been obvious to one of ordinary skill in the art before the effective filing date to have adjusted the color or improved visual differentiation between parts so they could be easier to distinguish between.
With regards to claim 56, Schieber-2017 fails to disclose wherein the leading tip has a tip length, and wherein the tip length is between 2.0 mm and 5.0 mm.
With regards to claim 57, Schieber-2017 fails to disclose wherein the leading tip has a tip width or diameter, wherein the tip width or diameter is between 100 pm and 300 pm.
However, Schieber’s tubular structure and core is entering the same space Schlemm’s canal has applicant’s therefore it would have been obvious to one of ordinary skill in the art before the effective filling date to have made the core (i.e. leading tip) structure to not only be small enough to fit inside the same specific anatomical location but also to fit within the tubular body which it resides in. (MPEP 2144.05 II. A.)
Claim(s) 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schieber US 2017/0360609 A9 (hereafter referred to as Schieber-2017) in view of Schieber US 2018/0369017 (hereafter referred to as Schieber-2018).
With regards to claim 8, 10, 12, and 14 Schieber-2017 fails to disclose wherein the leading tip is made of one or more non-bioabsorbable polymers per claim 8; wherein the leading tip is made of one or more bioabsorbable polymers per claim 10; wherein the leading tip is made of a biocompatible metallic material coated with a polymeric material per claim 12; and wherein the leading tip is an unbraided monofilament per claim 14
Schieber-2018 discloses an ocular implant of the same shape as Schieber-2017 for placing into Schlemm’s canal thereby in a related filed of endeavor. Schieber-2018 discloses the implant as a whole may have a coating and that it maybe non bioabsorbable, bioabsorabable, metallic, or unbraided monofilament such a single polymer [0194].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used a material such as one taught by Schieber-2018 in the device of Schieber-2017 since they have a similar structure and placed in the same anatomical location.
With regards to claim 9, Schieber-2017 as modified by Schieber-2018 discloses wherein the leading tip is made of at least one of polypropylene, polyethylene, polyamide, polyethylene terephthalate, polybutester, and co-polymers, blends, or composites thereof (Schieber-2018 [0194]).
With regards to claim 11, Schieber-2017 as modified by Schieber-2018 discloses wherein the leading tip is made of at least one of polylactide, polyglycolide, polycaprolactone, poly(trimethylene carbonate),polydioxanone, polyethylene glycol, polypropylene glycol, and co-polymers, blends, or composites thereof (Schieber-2018 [0194]).
With regards to claim 13, Schieber-2017 as modified by Schieber-2018 discloses the biocompatible metallic material is at least one of stainless steel and a nickel-titanium alloy (Schieber-2018 [0195]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The other references cited on the 892 that are not used for the rejection also capture the specific structure of the tubular body and may be relevant should additional structure of the tubular body be claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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