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 .
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.
Response to Amendment
The amendment filed 06/11/2026 has been entered. Claims 1-20 remain pending in the
application. Claims 17-20 remain withdrawn from consideration.
Response to Arguments
Applicant’s arguments filed 06/11/2026 with respect to claims 1, 3, 8, and 15 have been fully considered and are not persuasive.
Regarding Applicant’s argument that the references do not show a device capable of “loading, storing, transporting, and implanting ophthalmic tissue without the need to touch of physically manipulate the tissue, mitigating the risk of tissue damage”, the Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., touchless delivery) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the device of Chiang works by a different , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, Applicant’s critique solely of Chiang and it’s lack of touchless delivery and a first conduit that is not tapered is considered to be arguments against the reference individually, when this reference is a secondary reference. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that because Walter requires an additional step using mechanical rotation to get to the endothelium side facing down and the stomal side oriented up, the reference does not read on the claims, the Examiner disagrees. Walter discloses having the implant in this folded configuration, specifically discloses an ophthalmic tissue graft comprising an endothelium layer and a stromal layer (see column 8, lines 4-12), and the ophthalmic tissue graft is in a folded configuration with the stromal layer facing outward to contact the chamber inner surface and the endothelium layer facing inward in a direction away from a sloping portion of the beveled first end (see column 1, lines 47-53, the limitation in a direction away from a sloping portion of the beveled first end being interpreted as since the endothelium layer is inwards, it’s “away” from the inside of the delivery instrument and therefore also would be “away” from “a sloping portion of the beveled first end”). Furthermore, Applicant’s critique solely of Walter and it’s lack of touchless delivery and a first conduit that is not tapered is considered to be arguments against the reference individually, when this reference is a secondary reference. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For clarification, Szurmann is the primary reference, wherein all of the components of Chiang and Walter are not necessarily relied upon for the rejection. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Finally, Applicant’s critique solely of Szurmann and its lack of tri-fold configuration and chamber size is considered to be arguments against the reference individually, when this reference is a secondary reference. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument stating that Szurmann does not disclose a first conduit that is not tapered is disagreed upon, and the first conduit in the below rejection is not tapered. Applicant asserts that Szurmann does not disclose a pressure actuated element, and only discloses a device that can connect to a syringe. The Examiner disagrees. The syringe applies pressure to the device, therefore making the body of the device a pressure actuated element that supports the fluid that would be moved by said syringe.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-2, 7-11, 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170340428 A1 (hereafter --Szurmann--), in view of US 8673002 B2 (hereafter --Walter--), and further view of US 20200060808 A1 (hereafter --Chiang--).
Regarding Claim 1, Szurmann discloses a delivery apparatus for performing endothelial keratoplasty comprising:
(a) a first conduit having a beveled first end with a first opening (see annotated conduit, beveled end, and first opening in Figure 12 below), wherein the first conduit comprises:
(i) a sidewall that does not taper, and
(ii) an inner diameter (see annotated first conduit in Figure 12 below, the conduit not tapering and having an inner diameter as it has an inner round surface);
(b) a second conduit having a second end with a second opening; and
(c) a chamber that extends between the first conduit and the second conduit along a first axis (see annotated chamber and first/second conduit in Figure 12 below), wherein:
(i) the chamber has an interior thickness, the interior thickness extends along a second axis perpendicular to the first axis,
and wherein (ii) the chamber has an interior width, wherein the interior width extends along a third axis perpendicular to the first axis and the second axis (see annotated interior thickness Figure 12 below, the width being the width in the direction perpendicular to the thickness inside of the chamber).
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Szurmann fails to disclose the interior thickness of the chamber is between 0.4 millimeters and 0.8 millimeters and the interior width is between 2 millimeters and 4 millimeters, and wherein the interior width is greater than the first conduit outer diameter.
Walter discloses an ophthalmic delivery device for delivering an ophthalmic tissue graft wherein device comprises chamber that holds a graft (see Abstract, see also Figures 20A-20C, see annotated conduit and graft in Figure 1A below). Walter teaches the chamber can have a width between 3-6 mm (see column 7, lines 52-61).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the chamber width from between 3 mm and 6 mm. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have to have modified the chamber width from between 3 mm and 6 mm to between 2 millimeters and 4 millimeters as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0012]).
Further regarding the interior thickness, Chiang discloses a first conduit having a beveled first end with a first opening (see annotated conduit, beveled end, and first opening in Figure 15A below), a chamber along a first axis (see annotated chamber and first conduit in Figure 15A below), wherein: (i) the chamber has an interior thickness, the interior thickness extends along a second axis perpendicular to the first axis, and wherein (ii) the chamber has an interior width, the interior width extends along a third axis (see annotated interior thickness and width in Figures 15A-15C below). Chiang discloses a chamber wherein the interior thickness is less than the interior width, and wherein the interior width is greater than the first conduit outer diameter (see annotated conduit and chamber in Figures 15A-15C).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have to have modified the chamber shape to have the interior thickness is less than the interior width, as Chiang teaches that it is a known chamber shape in the art to defines a sufficient interior space and exterior protection to allow the graft to be stored in Optisol (a fluid solution) and in a trifold configuration (see paragraph [0020]). Furthermore, as this shape of chamber is known within the art and the modified width of the chamber is between 2 millimeters and 4 millimeters as claimed, it would have been obvious that the thickness of the chamber would be significantly less than the width range. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the chamber interior thickness of modified Szurmann be between 0.4 millimeters and 0.8 millimeters, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0012]).
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Although Szurmann fails to disclose the limitations regarding the tissue graft, Walter teaches that it’s well known in the art to have an ophthalmic tissue graft comprising an endothelium layer and a stromal layer (see column 8, lines 4-12), and the ophthalmic tissue graft is in a folded configuration with the stromal layer facing outward to contact the chamber inner surface and the endothelium layer facing inward in a direction away from a sloping portion of the beveled first end (see column 1, lines 47-53, the limitation in a direction away from a sloping portion of the beveled first end being interpreted as since the endothelium layer is inwards, it’s “away” from the inside of the delivery instrument and therefore also would be “away” from “a sloping portion of the beveled first end”). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the ophthalmic tissue graft of modified Szurmann be in a folded configuration, with the endothelium layer facing inward and the stromal layer facing outward to contact the conduit inner surface and the ophthalmic tissue graft endothelium layer is in contact with the corneal storage medium, as by doing so would allow placing of the donor stromal surface into contact with the recipient stromal bed for self-adhesion (see column 1, lines 58-63).
Regarding Claim 2, Szurmann as modified discloses the delivery apparatus of claim 1.
Szurmann as modified fails to disclose wherein: (a) the first conduit comprises an inner diameter between 1.1 millimeters and 2.2 millimeters; and (b) the second conduit comprises an inner diameter between 1.1 millimeters and 2.2 millimeters.
Walter discloses an ophthalmic delivery device for delivering an ophthalmic tissue graft wherein device comprises chamber that holds a graft (see Abstract, see also Figures 20A-20C, see annotated conduit and graft in Figure 1A below). Walter teaches the chamber can have a cross sectional width between less than 3 mm (see column 7, lines 52-61).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have to have modified the first conduit diameter to be less than 3 mm, as by doing so would make the device suitable for entering a scleral access incision sized at less than about 4 mm (for example, about 3 mm) (see column 2, lines 19-24), and to have to have modified the second conduit diameter to be less than 3 mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have to have modified the first conduit and second conduit diameters to be from less than 3 mm to between 1.1 millimeters and 2.2 millimeters as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see paragraph [0012]).
Regarding Claim 7, Szurmann as modified discloses the delivery apparatus of claim 1, wherein (a) the chamber houses an ophthalmic tissue graft (see annotated chamber and see graft 4 within the chamber in Figure 12 above).
Szurmann as modified fails discloses the ophthalmic tissue graft endothelium layer is in contact with a corneal storage medium.
Walter discloses an ophthalmic delivery device for delivering an ophthalmic tissue graft (see Abstract, see also Figures 20A-20C). Walter teaches that it’s well known in the art to have an ophthalmic tissue graft comprising an endothelium layer and a stromal layer (see column 8, lines 4-12), and the ophthalmic tissue graft is in a folded configuration with the endothelium layer facing inward and the stromal layer facing outward to contact the conduit inner surface (see column 1, lines 47-53); and (b) the ophthalmic tissue graft endothelium layer is in contact with the corneal storage medium (see column 1, lines 57-63).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the ophthalmic tissue graft endothelium layer be in contact with the corneal storage medium, as by doing so would further assist with pushing the donor tissue out of the beveled first end (see column 3, lines 46-47, see also column 8, lines 52-54).
Regarding Claim 8, Szurmann discloses a delivery apparatus for performing endothelial keratoplasty comprising: (a) a first conduit comprising (i) a beveled first end with a first opening (see annotated first conduit, first opening, and beveled first end in Figure below), (ii) a sidewall that does not taper (see annotated first conduit in Figure 12 below), and (iii) a circular or elliptical cross section (see annotated first conduit in Figure 12 below); (b) a second conduit having a second end with a second opening (see annotated second conduit and second opening in Figure 12 below); and (c) a chamber (5) that extends between the first conduit and the second conduit (see annotated chamber in Figure 12 below), the chamber is sized to accommodate cornea tissue (see graft 4 in Figure 12 below).
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Szurmann fails to disclose the chamber comprises a flattened, hollow body that has an interior width that is wider than the an inner diameter of the first conduit and wider than an inner diameter of the second conduit, and wherein (ii) the chamber is sized to accommodate cornea tissue with an endothelial cell layer on a first side while the cornea tissue is in a trifolded configuration with the endothelial cell layer facing inward away from an interior surface of the chamber and orientated in an endothelium-in configuration relative to the orientation of the beveled first end with the endothelium layer facing away from a sloping portion of the first end.
Walter teaches that it’s well known in the art to have an ophthalmic tissue graft comprising an endothelium layer and a stromal layer (see column 8, lines 4-12), and the ophthalmic tissue graft is in a trifolded configuration with the endothelial cell layer facing inward away from an interior surface of the chamber and orientated in an endothelium-in configuration relative to the orientation of the beveled first end with the endothelium layer facing away from a sloping portion of the first end (see column 1, lines 47-53, the limitation in a direction away from a sloping portion of the beveled first end being interpreted as since the endothelium layer is inwards, it’s “away” from the inside of the delivery instrument and therefore also would be “away” from “a sloping portion of the first end”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the ophthalmic tissue graft be in a folded configuration, with the endothelium layer facing inward and the stromal layer facing outward to contact the conduit inner surface, as by doing so would allow placing of the donor stromal surface into contact with the recipient stromal bed for self-adhesion (see column 1, lines 58-63).
Szurmann further fails to disclose the chamber having a flattened, hollow body that has an interior width that is wider than the inner diameter of the first conduit and wider than an inner diameter of the second conduit.
Chiang discloses an eye graft delivery device with a first conduit and a chamber for use in a DMEK procedure, in which the graft is in a tri-folded configuration (see Abstract, see also paragraph [0046], see also annotated conduit and chamber in Figures 15A-15C). Chiang teaches the chamber comprising a flattened, hollow body that is wider than the first conduit (see annotated conduit and chamber in Figures 15A-15C).
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Therefore, the substitution of one known element (a round chamber as taught by Szurmann) for another (a flattened and wider chamber as taught by Chiang) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the chamber shape of Chiang for the chamber shape of Szurmann would have yielded predictable results, namely, a chamber that is flattened, hollow, and wider than the inner diameters of the conduits. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the chamber to comprise a flattened, hollow body that is wider than the first conduit, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Additionally, the Instant Application does not disclose the chamber being wider than the second conduit solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Szurmann as modified’s device would perform equally and function as intended with the chamber not being wider than the second conduit. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the chamber to comprise a flattened, hollow body that is wider than the second conduit, as an obvious matter of design choice within the skill of the art.
Regarding Claim 9, Szurmann as modified discloses the delivery apparatus of claim 8, wherein the second opening is coupled to, and in fluid motion with, a fluid manipulation device (see annotated second opening and syringe, being the fluid manipulation device).
Regarding Claim 10, Szurmann as modified discloses the delivery apparatus of claim 9, further comprising a delivery device carrier (2), wherein the delivery device carrier comprises: (a) a container having an opening; (b) a cap configured to seal the opening of the container (see paragraph [0046]); and (c) at least a portion of the delivery device is disposed within the container (see annotated device and container in Figure 12 above, see also paragraph [0012]).
Regarding Claim 11, Szurmann as modified discloses the delivery apparatus of claim 10, wherein the delivery device and the container are each at least partially filled with a corneal storage medium (see annotated corneal storage medium in Figure 12 above, see also paragraph [0042], [0043] and [0048]).
Regarding Claim 13, Szurmann as modified discloses the delivery apparatus of claim 8, further comprising a pressure actuated valve coupled to the second end (see annotated second end and pressure actuated valve in Figure 12 above).
Regarding Claim 14, Szurmann as modified discloses the delivery apparatus of claim 13, further comprising a syringe coupled to the pressure actuated value (see annotated syringe and pressure actuated valve in Figure 12 above).
Regarding Claim 16, Szurmann as modified discloses the delivery apparatus of claim 14, wherein:(a) the pressure actuated value is coupled to the second end through a resilient member (9) (see annotated resilient member in Figure 12 above, see paragraph [0017] denoting closure member 9 is made of an elastic member); and wherein (b) the resilient member comprises a channel extending from a first aperture to a second aperture (see annotated channel, first aperture, and second aperture in Figure 12 above); and wherein: (c) the resilient member is coupled to the second portion of the pressure-actuated valve by extending the second portion partially through the resilient member first aperture (see annotated second portion and first aperture in Figure 12 above); and wherein (d) the resilient member is coupled to the second end by extending the second end partially through the resilient member second aperture (see annotated second end in Figure 12 above).
Claims 3-5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170340428 A1 (hereafter --Szurmann--), in view of US 8673002 B2 (hereafter --Walter--), and further view of US 20200060808 A1 (hereafter --Chiang--), in even further view of US 20210154004 A1 (hereafter --Dockhorn--).
Regarding Claim 3, Szurmann as modified discloses the delivery apparatus of claim 1, further comprising a pressure actuated valve (valve being define as “any of numerous mechanical devices by which the flow of liquid, gas, or loose material in bulk may be started, stopped, or regulated by a movable part that opens, shuts, or partially obstructs one or more ports or passageways” (see Merriam Webster online definition 1a), the movable part being the syringe that “starts” the movement of the liquid by pushing the liquid and therefore obstructing the passageway that it is pushing the liquid through when it enters), wherein the pressure actuated valve comprises:
(a) a first portion configured for coupling to a syringe at an inlet (see annotated syringe and first portion in Figure 12 above, the inlet being the aperture at the first portion);
(b) a valve main body (see annotated valve main body in Figure 12 above);
(c) a second portion in fluid communication with the injector second end at an outlet (see annotated second portion in Figure 12 below, the outlet being the aperture at the second portion).
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Szurmann as modified fails to disclose a deformable stopper disposed in the main body, wherein the stopper comprises (i) a first state in which the deformable stopper is not deformed and covers the entire outlet or the entire inlet, and(ii) a second state in which the deformable stopper is deformed and does not cover the entire inlet and does not cover the entire outlet.
Dockhorn discloses a delivery apparatus for delivery of IOLs into a patient (see Abstract). Dockhorn teaches a deformable stopper disposed in the main body (see paragraph [0055]), wherein the stopper comprises (i) a first state in which the deformable stopper is not deformed and covers the entire outlet [or the entire inlet] (see annotated deformable stopper and outlet in Figure 14 below, see also paragraph [0104]).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, for the device to have a deformable stopper disposed in the main body, wherein the stopper comprises a first state in which the deformable stopper is not deformed and covers the entire outlet or the entire inlet, as by doing so would enable the device to set and maintain a certain position of the distal end of the syringe, at which position a stop can be made and certain preparatory steps can be carried out (see paragraph [0106]) as well as the stop being deformable would enable the syringe to reach a reserve feed area in order to be able, if necessary, to fully eject a lens from the injector which has not yet been fully ejected in a previous position (see paragraph [0111]).
The limitation “a second state in which the deformable stopper is deformed and does not cover the entire inlet and does not cover the entire outlet” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the stopper being against an outlet and the stopper being made of deformable material as disclosed by the prior art, the apparatus would be capable of the stopper not completely covering the outlet when deformed, as the stopper is capable of changing shape under manual pressure (see paragraph [0111]).
Regarding Claim 4, Szurmann as modified discloses the delivery apparatus of claim 3, further comprising: (a) an elongated resilient member (see annotated resilient member in Figure 12 above, see paragraph [0017] denoting closure member 9 is made of an elastic member) having a channel extending from a first aperture to a second aperture (see annotated channel, first aperture, and second aperture in Figure 12 above), wherein (i) the resilient member is coupled to the second portion of the pressure- actuated valve by extending the second portion partially through the resilient member first aperture (see annotated second portion and first aperture in Figure 12 above), and wherein (ii) the resilient member is coupled to the delivery apparatus second end by extending the second end partially through the resilient member second aperture (see annotated second end in Figure 12 above).
Regarding Claim 5, Szurmann as modified discloses the delivery apparatus of claim 4, further comprising a syringe filled with a balanced salt solution coupled to the first portion of the pressure actuated valve (see paragraph [0052]).
Regarding Claim 15, Szurmann as modified discloses the delivery apparatus of claim 13, wherein the pressure actuated value comprises: (a) a first portion with an inlet configured for coupling to a syringe (see annotated first portion in Figure 12 below); (b) a valve main body (see annotated valve main body in Figure 12 below); (c) a second portion with an outlet coupled to the second end of the second conduit (see annotated second portion in Figure 12 below, the outlet being the aperture at the second portion); and (c) a second portion coupled to the second end of the second conduit (see annotated second portion in Figure 12 above).
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Szurmann as modified fails to disclose a deformable stopper disposed in the main body, wherein the stopper comprises (i) a first state in which the deformable stopper is not deformed and covers the entire outlet or the entire inlet, and(ii) a second state in which the deformable stopper is deformed and does not cover the entire inlet and does not cover the entire outlet.
Dockhorn discloses a delivery apparatus for delivery of IOLs into a patient (see Abstract). Dockhorn teaches a deformable stopper disposed in the main body (see paragraph [0055]), wherein the stopper comprises (i) a first state in which the deformable stopper is not deformed and covers the entire outlet [or the entire inlet] (see annotated deformable stopper and outlet in Figure 14 below, see also paragraph [0104]).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, for the device to have a deformable stopper disposed in the main body, wherein the stopper comprises a first state in which the deformable stopper is not deformed and covers the entire outlet or the entire inlet, as by doing so would enable the device to set and maintain a certain position of the distal end of the syringe, at which position a stop can be made and certain preparatory steps can be carried out (see paragraph [0106]) as well as the stop being deformable would enable the syringe to reach a reserve feed area in order to be able, if necessary, to fully eject a lens from the injector which has not yet been fully ejected in a previous position (see paragraph [0111]).
The limitation “a second state in which the deformable stopper is deformed and does not cover the entire inlet and does not cover the entire outlet” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the stopper being against an outlet and the stopper being made of deformable material as disclosed by the prior art, the apparatus would be capable of the stopper not completely covering the outlet when deformed, as the stopper is capable of changing shape under manual pressure (see paragraph [0111]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170340428 A1 (hereafter --Szurmann--), in view of US 8673002 B2 (hereafter --Walter--) and US 20200060808 A1 (hereafter --Chiang--), as applied to claim 5 above, in further view of US 20130165860 A1 (hereafter --Doud--).
Regarding Claim 6, Szurmann discloses the ophthalmic tissue delivery apparatus of claim 5.
Szurmann fails to disclose wherein the elongated hollow body further comprises a bulb disposed on an outer surface of the second conduit.
Doud discloses an ophthalmic tissue delivery apparatus for performing endothelial keratoplasty comprising:(a) an injector that comprises (i) an elongated hollow body (see paragraph [0140]), (ii) an inner surface that defines a conduit (see paragraph [0140]), (iii) a beveled first end having a first opening (see annotated beveled first end in Figure 8A below), and (iv) a second end having a second opening (see paragraph [0112] denoting that there is an opening in the injector 201 to receive the fluid from the chamber 250); (b) a pressure actuated valve (250) that comprises (i) a first portion configured for coupling to a syringe (see annotated first portion in Figure 8A below), (ii) a valve main body (see annotated valve main body in Figure 8A below), (iii) a deformable stopper disposed in the main body (see annotated stopper in Figure 8A below), and (iv) a second portion in fluid communication with the injector second end (see annotated second portion in Figure 8A below). Doud teaches wherein the elongated hollow body of the conduit further comprises a bulb disposed on an outer surface of the elongated hollow body (see annotated bulb in Figure 30B below).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the elongated hollow body of Szurmann further comprise a bulb disposed on an outer surface of the second conduit, as by doing so would provide one or more channels extending along the elongate hollow body to pass the fluid of the implantable device through the septum (see paragraph [0138]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170340428 A1 (hereafter --Szurmann--), in view of US 8673002 B2 (hereafter --Walter--) and US 20200060808 A1 (hereafter –Chiang--), as applied to claim 8 above, in even further view of US 20130165860 A1 (hereafter --Doud--).
Regarding Claim 12, Szurmann as modified discloses the ophthalmic tissue delivery apparatus according to claim 8, wherein:(a) the beveled first end comprises a leading portion and a trailing portion (see annotated leading and trailing portion in Figure 12 above); and (c) the trailing portion comprises a non-cutting surface (see paragraph [0051] denoting the end is used for insertion into an incision).
Szurmann as modified fails to disclose the leading portion comprises a cutting surface for cutting and penetrating eye tissue.
Doud teaches wherein the beveled first end comprises a leading portion and a trailing portion (see annotated trailing and leading portion in Figure 6 below), the leading portion comprises a cutting surface for cutting and penetrating eye tissue (see annotated cutting surface in Figure 6 below, see paragraph [0129]); and the trailing portion comprises a non-cutting surface (see annotated non-cutting surface in Figure 6 below).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first conduit beveled end of Szurmann further comprise of comprises a leading portion and a trailing portion, the leading portion comprises a cutting surface for cutting and penetrating eye tissue; and the trailing portion comprises a non-cutting surface, as by doing so would enable the injector beveled end to penetrate tissue and to inject therapeutic fluid through the opening of the injector as taught by Doud (see paragraph [0129]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220015944 A1: Barker discloses an ophthalmic tissue delivery apparatus for performing endothelial keratoplasty comprising:(a) an injector that comprises (i) an elongated hollow body (see annotated delivery apparatus and injector in Figure 4 below), (ii) an inner surface that defines a conduit (see annotated inner surface in Figure 4 below), the conduit containing ophthalmic tissue (see paragraph [0048]), (iii) a beveled first end having a first opening (see annotated first opening and beveled end in Figure 4 below, see also paragraph [0051]), (iv) a second end having a second opening (see paragraphs [0053] and [0060] denoting that there’s a fluid channel 220 that is held with an end portion of the cannula, see also Figure 9 showing that 220 is on the opposite end of the first opening), and (v) wherein the elongated hollow body does not include any openings along its length; (b) a fluid delivery device (220) that comprises a fluid reservoir (220) filled with a delivery fluid (see paragraph [0053]) and an actuator (see paragraph [0053] denoting that fluid can be delivered through 220 from a pressurized fluid source, such as a syringe, infusion pump, of hanging fluid bag, the source being the actuator) (c) a pressure actuated valve (250) that comprises (i) a first portion with an inlet, wherein the first portion is coupled to the fluid delivery device (see paragraph [0062] denoting that the valve 250 is connected to component 220, see paragraph [0060] denoting that the fluid delivery device is connected with channel 220, see Figure 9 showing 240 connected to 250, in which that connection is the “inlet”) (ii) a valve main body having an internal volume (see paragraph [0062] denoting that the junction between components 230 and 240 is the valve, which has an internal volume), (iii) a second portion having an outlet see Figure 9 showing 230 connected to 250, in which that connection is the “outlet”, and 230 is connected to 40) that is coupled to and in fluid communication with the injector second end (see paragraphs [0053] and [0062] denoting that valve or gasket is in fluid communication with 220 and see paragraph [0053] denoting that gasket/valve is distal to the channel 220 and the cannula to ensure that fluid does not go into body 110b, see Figure 6 for where 110 is relative to 40) (iv) a deformable stopper (260) disposed in the main body, wherein the stopper covers the entire outlet or the entire inlet (see paragraph [0062]).
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THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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