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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/26/2026 has been entered.
Response to Amendment
The amendment filed 02/26/2026 has been entered. Claims 1-3, 5-11, 13, 14-15, and 16-22 remain pending. Claims 16-19 remain withdrawn from consideration. Claims 3, 14, and 15 are objected to. Claims 4 and 12 have been cancelled.
Response to Arguments
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive.
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 is a distinguishable feature) 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).
Regarding Applicant’s argument that Barker does not disclose a device with the same dimensions claimed by Applicant, the Examiner respectfully disagrees. Barker discloses that the cannula (distal tip) 40 (beveled first end/first opening of the injector in Figure 4 below), facilitates the entry of the graft into the eye by inserting the tip into the incision of the eye (see paragraph [0051]), and then even further discloses that the entry incision in the eye can be less than about 4 mm in length (see paragraph [0020]), that the cannula cavity has a width that is between 3-6 mm, and that the outside diameter of the donor cornea can be about 2.5 mm to about 3 mm, all of which are ranges that overlap with the claimed ranges of 1.1 to 3.2 millimeters, 2.2 to 4.0 millimeters, and less than 4 millimeters, all ranges in which have to do with the dimensions of the distal tip (injector) that is disclosed to be inserted into the incision in which the range overlaps with the claimed ranges. Due to this, the distal tip is also within the range of the incision of the eye, and 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 injector size from between 3 mm and 6 mm have the to disclose an inner diameter between 1.1 millimeters and 3.2 millimeters; (b) the injector comprises an outer diameter between 2.2 millimeters and 4.0 millimeters; and (c) the beveled first end has a bevel outer diameter that less is than 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]). Since the Applicant has not placed criticality one the claimed range, and since the device of the prior art discloses an inner diameter with an overlapping range and claims that the incision that the injector enters into can be less than 4 mm (making it obvious that the outer diameter of the injector would therefore have to be less than 4 mm to fit in said incision), the rejections are sustained.
Regarding Applicant’s argument that Doud does not disclose a pressure actuated valve, the Examiner respectfully disagrees. The Figure denoted that 700 was the component that the valve was referring to, the use of 250 in the text was a typo. This as well as Figure 8A has been fixed for clarity. The reference discloses a valve as shown by paragraphs [0241] and [0242]). Regardless, since Doud is not a primary reference and the limitation of a pressure actuated valve is covered by the primary reference, this is not relevant to advance prosecution.
Applicant's arguments regarding claim 6 filed 02/26/2026 have been fully considered but they are moot in the newly applied rejection below.
Claim Objections
Claims 14 and 15 is objected to because of the following informalities:
Regarding Claim 14, t Appropriate correction is required.
Regarding Claim 15, t Appropriate correction is required.
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.
Claims 1 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20220015944 A1 (hereafter --Barker--).
Regarding Claim 1, 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]) in a rolled configuration (see paragraph [0067]),
(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 (250) disposed in the main body, wherein the stopper comprises
(A) a first state in which the deformable stopper is not deformed and covers the entire outlet or entire inlet and wherein the ophthalmic tissue is contained entirely within the conduit (see paragraph [0062] denoting that the valve only allows fluid in one direction, in which when fluid is not flowing through the valve 250 it is “not deformed” and covers the “inlet/outlet,” the stopper being the component that stops fluid from flowing in both directions).
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The limitation “(B) a second state in which the deformable stopper is deformed and does not cover the entire inlet and does not cover the entire outlet (see paragraph [0062] denoting that the valve (250) is a one-way valve, in which the one-way valve 250 is deformable to allow fluid flow in only one direction, the stopper being the component that stops fluid from flowing in both directions), wherein in the second state (I) the elongated hollow body (40) first opening is in fluid communication with fluid delivery device (220) (see paragraph [0060]), (II) the delivery fluid is present in the conduit and in contact with the ophthalmic tissue (see paragraphs [0053] and [0060]), and (III) the ophthalmic tissue is positioned at least partially outside the first opening (see paragraphs [0095] and [0096] describing the ophthalmic tissue exiting from the first opening of the cannula 40 (elongated hollow body) ” 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. Since the fluid can be pushed through the channel 220 and into the cannula (through the valve as the valve is in between 40 and 220) to then push the graft out the cannula and into the eye (see paragraphs [0053], [0060], and [0095]), the device is capable of the above limitation.
Regarding Claim 20, Barker discloses the ophthalmic tissue delivery apparatus of claim 1, wherein the conduit comprises an inner surface that extends along the length of the elongated hollow body, wherein the inner surface is smooth and continuous (see annotated inner surface in Figure 4 above).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over US 20220015944 A1 (hereafter --Barker--).
Regarding Claim 2, Barker discloses the ophthalmic tissue delivery apparatus of claim 1.
Barker further discloses that the cannula (distal tip) 40 (beveled first end/first opening of the injector in Figure 4 below), facilitates the entry of the graft into the eye by inserting the tip into the incision of the eye (see paragraph [0051]), and then even further discloses that the entry incision in the eye can be less than about 4 mm in length (see paragraph [0020]), that the cannula cavity has a width that is between 3-6 mm, and that the outside diameter of the donor cornea can be about 2.5 mm to about 3 mm, all of which are ranges that overlap with the claimed ranges of 1.1 to 3.2 millimeters, 2.2 to 4.0 millimeters, and less than 4 millimeters, all ranges in which have to do with the dimensions of the distal tip (injector) that is disclosed to be inserted into the incision in which the range overlaps with the claimed ranges. Due to this, the distal tip is also within the range of the incision of the eye, and 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 injector size from between 3 mm and 6 mm have the to disclose an inner diameter between 1.1 millimeters and 3.2 millimeters; (b) the injector comprises an outer diameter between 2.2 millimeters and 4.0 millimeters; and (c) the beveled first end has a bevel outer diameter that less is than 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]).
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 20220015944 A1 (hereafter --Barker--), in view of US 20130165860 A1 (hereafter --Doud--).
Regarding Claim 5, Barker discloses the ophthalmic tissue delivery apparatus of claim 1.
Barker fails to disclose wherein the elongated hollow body further comprises a bulb disposed on an outer surface of the elongated hollow body.
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 (700 that is within chamber 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 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 Barker further comprise a bulb disposed on an outer surface of the elongated hollow body, 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]).
Claims 6-8, 11, 13, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20220015944 A1 (hereafter --Barker--), in view of US 20150342726 A1 (hereafter --Deacon--).
Regarding Claim 6, Barker discloses an ophthalmic tissue apparatus for performing endothelial keratoplasty comprising:
(a) an elongated hollow body wherein the elongated hollow body comprises
(i) an inner surface (see annotated elongated body and inner surface in Figure 4 below), wherein (A) the inner surface defines a conduit (see annotated inner surface in Figure 4 below), and (C) the conduit contain ophthalmic tissue in rolled configuration with overlapping ophthalmic tissue edges (see paragraphs [0047], [0070] denoting “the donor tissue disc 60 may be shaped so that one edge 60a rolls under the opposing edge 60b”, and [0077])
(iii) a beveled first end having a first opening (see annotated beveled first end and first opening in Figure 4 below, see also paragraph [0095]);
(iv) a second end having a second opening; and
(b) a fluid manipulation device (220) coupled to the elongated hollow body second end (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), wherein
(i) the fluid manipulation device comprising a pressure actuated valve and a syringe (see paragraph [0053] denoting that 220 can be connected to a syringe, see paragraph [0062] denoting that 220 can be connected to a valve),
(iii) the pressure actuated valve comprises a closed position and an open position (see paragraph [0062]), wherein (C) the fluid is present in conduit and applies a fluid pressure to the ophthalmic tissue, and (D) the ophthalmic tissue extends partially through the first opening (see paragraphs [0053] and [0060]), see also paragraphs [0095] and [0096] describing the ophthalmic tissue exiting from the first opening of the cannula 40 (elongated hollow body)).
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Barker further discloses that the cannula (distal tip) 40 (beveled first end/first opening of the injector in Figure 4 above), facilitates the entry of the graft into the eye by inserting the tip into the incision of the eye (see paragraph [0051]), and then even further discloses that the entry incision in the eye can be less than about 4 mm in length (see paragraph [0020]), that the cannula cavity has a width that is between 3-6 mm, and that the outside diameter of the donor cornea can be about 2.5 mm to about 3 mm, all of which are ranges that overlap with the claimed ranges of 1.1 to 3.2 millimeters and less than 4 millimeters, all ranges in which have to do with the dimensions of the distal tip (injector) that is disclosed to be inserted into the incision in which the range overlaps with the claimed ranges. Due to this, the distal tip is also within the range of the incision of the eye, and 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 injector size from between 3 mm and 6 mm have the to disclose an inner diameter between 1.1 millimeters and 3.2 millimeters and the beveled first end have a bevel outer diameter that is less is than 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 in regards to claim 6: Barker fails to disclose wherein the syringe comprises (A) a barrel containing a fluid, and (B) a plunger at least partially housed within the barrel such that depressing the plunger applies pressure to the fluid, (iv) the plunger is movable from a first position to a depressed position (v) when the plunger is in the first position, the pressure actuated valve is in the closed position and the barrel is not in fluid communication with the elongated hollow body, and (vi) when the plunger is in the depressed position (A) the actuated valve is the open position, (B) the barrel is in fluid communicated with the elongated hollow body first body opening.
Deacon discloses an ophthalmic tissue delivery apparatus for performing endothelial keratoplasty comprising: (a) an injector that comprises (i) an elongated hollow body (see annotated injector and elongated hollow body in Figures 11-12 below), and a pressure actuated valve (340, 342). Deacon teaches wherein the syringe comprises (A) a barrel containing a fluid, and (B) a plunger at least partially housed within the barrel such that depressing the plunger applies pressure to the fluid (see paragraph [0066]), (iv) the plunger is movable from a first position (see Figure 11 below) to a depressed position (see Figure 12 below, see also paragraph [0066]) (v) when the plunger is in the first position, the pressure actuated valve is in the closed position and the barrel is not in fluid communication with the elongated hollow body (see paragraph [0066] and Figure 11 showing that the fluid “F” is within the barrel and not flowing into the delivery device, as the one way valve is closed and plunger is not compressed), and (vi) when the plunger is in the depressed position (A) the actuated valve is the open position, (B) the barrel is in fluid communicated with the elongated hollow body first body opening (see paragraph [0066] denoting that the syringe plunger 32 may be depressed, thereby driving fluid F past the one-way valve 342 and into the master cylinder 314 by way of the valve 340).
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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 syringe of Barker to have (i) a barrel containing a fluid, and (ii) a plunger partially housed within the barrel such that depressing the plunger applies pressure to the fluid, (iv) the plunger is movable from a first position to a depressed position (v) when the plunger is in the first position, the pressure actuated valve is in the closed position and the barrel is not in fluid communication with the elongated hollow body, and (vi) when the plunger is in the depressed position (A) the actuated valve is the open position, (B) the barrel is in fluid communicated with the elongated hollow body first body opening, as by doing so would allow fluid to be pushed from the syringe and into the cylinder of the fluid delivery device (see paragraph [0066]).
Regarding Claim 7, Barker as modified discloses the ophthalmic tissue delivery apparatus according to claim 6 further comprising an injector carrier (200), wherein the injector carrier comprises:
(a) a container having an opening;
(b) a cap (210) configured to seal the opening of the container (see paragraph [0055] and Figure 3); and
(c) at least a portion of the ophthalmic tissue apparatus is disposed within the container (see paragraph [0088]).
Regarding Claim 8, Barker as modified discloses the ophthalmic tissue delivery apparatus according to claim 7, wherein the conduit and the container are each at least partially filled with a corneal storage medium (see paragraph [0055]).
Regarding Claim 11, Barker as modified discloses the ophthalmic tissue delivery apparatus according to claim 6 wherein the pressure actuated valve is coupled to the elongated hollow body second end on a first valve end (end of the valve or “junction” between 240 and 230 that is connected to portion 230 is the second portion coupled to the injector second end is the “first valve end”, see Figure 9). and the pressure actuated valve is coupled to the syringe at a second valve end (portion of junction attached to 240, which is then attached to 190 and a syringe through 220 as described in paragraph [0053] is the “second valve end”, see also Figure 9).
Regarding Claim 13, Barker as modified discloses the ophthalmic tissue delivery apparatus according to claim 11, wherein the pressure actuated value comprises:
(a) a first portion (portion of junction attached to 240, which is then attached to 190 through 220 as described in paragraph [0053], see also Figure 9) configured for coupling to a syringe;
(b) a valve main body (portion in between 230 and 240 is the main body, see Figure 9) ;
(c) a deformable stopper (250 disposed in the main body (see paragraph [0062] denoting that the valve (250) is a one-way valve, in which the one-way valve 250 is deformable to allow fluid flow in only one direction, the stopper being the component that stops fluid from flowing in both directions); and
(d) a second portion coupled to the injector second end (portion that is connected to portion 230 is the second portion coupled to the injector second end, see Figure 9).
Regarding Claim 21, Barker as modified discloses the ophthalmic tissue delivery apparatus of claim 6.
The limitation “wherein the ophthalmic tissue delivery apparatus is configured such that actuation of a plunger of the syringe causes the pressure actuated valve to open and permit fluid flow through the injector” 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. Since the fluid can be pushed through the channel 220 and into the cannula (through the valve as the valve is in between 40 and 220) to then push the graft out the cannula and into the eye (see paragraphs [0053], [0060], and [0095]), the device is capable of the above limitation.
Regarding Claim 22, Barker as modified discloses the ophthalmic tissue delivery apparatus of claim 6. The limitation “wherein depressing the plunger dispenses an ophthalmic tissue graft loaded in the conduit through the beveled first end into an eye of a patient” 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. Since the fluid can be pushed through the channel 220 and into the cannula (through the valve as the valve is in between 40 and 220) to then push the graft out the cannula and into the eye (see paragraphs [0053], [0060], and [0095]), the device is capable of the above limitation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 20220015944 A1 (hereafter --Barker--), in view of US 20150342726 A1 (hereafter --Deacon--), in even further view of US 20130165860 A1 (hereafter --Doud--).
Regarding Claim 10, Barker as modified Deacon discloses the ophthalmic tissue delivery apparatus according to claim 6.
Barker as modified Deacon fails to disclose what tool is used to create the incision in the eye, as well as fails to disclose wherein the beveled first end 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.
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 injector beveled end of Barker 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]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 20220015944 A1 (hereafter --Barker--), in view of US 20130165860 A1 (hereafter --Doud--), in even further view of US 8673002 B2 (hereafter --Walter--).
Regarding Claim 9, Barker as modified discloses the ophthalmic tissue delivery apparatus according to claim 8.
Barker as modified fails to disclose (a) the conduit houses an ophthalmic tissue graft comprising an endothelium layer and a stromal layer, 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; and (b) the ophthalmic tissue graft endothelium layer is in contact with the 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 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).
Allowable Subject Matter
Claims 3, 14, and 15 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.
The claims are allowable if rewritten in independent form for the following reasons:
The prior art fails to disclose or suggest, in combination with other limitations recited in the claims, wherein 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, and wherein the resilient member is coupled to the injector second end by extending the injector second end partially through the resilient member second aperture.
US 20220015944 A1 (hereafter –Barker--):
Regarding claim 3, 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]), and (A) when the fluid delivery device actuator extends into the fluid reservoir the volume of the fluid reservoir is reduced thereby pushing the delivery fluid out of the fluid delivery device and into the pressure actuated valve first portion through the valve inlet, (B) when the delivery fluid enters the valve main body from the pressure actuated valve first portion inlet, the deformable stopper deforms and does not cover the entire inlet or outlet, thereby allowing the delivery fluid to pass through the second portion into the injector second end, and (C) wherein when the delivery fluid enters the injector conduit through the injector second opening, the ophthalmic tissue is expelled from the injector first opening (see paragraphs [0060], [0053], and [0095] denoting that the fluid can be pushed through the channel 220 and into the cannula (through the valve as the valve is in between 40 and 220) to then push the graft out the cannula and into the eye), and an elongated resilient member (50) having a channel extending from a first aperture to a second aperture (see paragraph [0048] denoting that component 50 is flexible).
Regarding claims 14 and 15, Barker discloses an ophthalmic tissue apparatus for performing endothelial keratoplasty comprising:(a) an elongated hollow body; (b) an inner surface of the elongated hollow body (see annotated elongated body and inner surface in Figure 4 above), wherein (i) the inner surface defines a conduit (see annotated inner surface in Figure 4 above), and wherein (ii) the conduit comprises an inner diameter between 1.1 millimeters and 3.2 millimeters (see paragraph [0071]); (c) an outer diameter of the elongated hollow body, wherein the outer diameter is less than 4 millimeters (see paragraph [0071] overlapping ranges); (d) a beveled first end having a first opening (see annotated beveled first end and first opening in Figure 4 above, see also paragraph [0095]); (e) a second end having a second opening, wherein the second end is coupled to, and in fluid communication with, a fluid manipulation device (220) (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 (f) the fluid manipulation device comprising a pressure actuated valve and a syringe (see paragraph [0053] denoting that 220 can be connected to a syringe, see paragraph [0062] denoting that 220 can be connected to a valve).
Barker fails to disclose (a) the pressure actuated value is coupled to the elongated hollow body second end through a resilient member; and wherein (b) the resilient member comprises a channel extending from a first aperture to a second aperture; 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; and wherein (d) the resilient member is coupled to the ophthalmic tissue apparatus second end by extending the ophthalmic tissue apparatus second end partially through the resilient member second aperture, the elongated hollow body further comprises a bulb disposed on an outer surface of the elongated hollow body; and the ophthalmic tissue apparatus second end extends through the resilient member second aperture such that bulb is within the resilient member channel.
US 20090270982 A1 (hereafter --Torres--):
Regarding claim 3, Torres discloses an ophthalmic tissue delivery apparatus for performing endothelial keratoplasty comprising:(a) an injector that comprises (i) an elongated hollow body (see elongated hollow body in Figure 3 below), (ii) an inner surface that defines a conduit (see annotated inner surface in Figure 3 below, see also paragraph [0059] denoting that this surface holds the tissue graft and fluid), (iii) a beveled first end having a first opening, and (iv) a second end having a second opening (see annotated second and first ends in Figure 3 below); (b) a valve (see annotated valve in Figure 2 below) that comprises a first portion configured for coupling to a syringe (see annotated first portion in Figure 2 below, see annotated syringe and valve 128 in Figure 2 below), a valve main body (see annotated valve main body in Figure 2 below), and a second portion in fluid communication with the injector second end (see annotated second portion being connected to the injector second end as shown in Figure 2 below).
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Regarding claims 14 and 15, Torres discloses an ophthalmic tissue apparatus for performing endothelial keratoplasty comprising: (a) an elongated hollow body (see annotated elongated hollow body in Figure 3 below); (b) an inner surface of the elongated hollow body, wherein (i) the inner surface defines a conduit (see annotated inner surface in Figure 3 below, see also paragraph [0073]), and wherein: (d) a beveled first end having a first opening (see annotated first end and opening in Figure 3 below); (e) a second end having a second opening (see annotated second end in Figure 3 below), wherein the second end is coupled to, and in fluid communication with, a fluid manipulation device (see paragraph [0065], see Figures 2 and 3 below). Torres further discloses that the distal tip portion 146 (beveled first end/first opening of the injector in Figure 3 below), facilitates the entry of the graft into the eye by inserting the tip into the incision of the eye (see paragraphs [0060], [0073], [0084]), and then even further discloses that the entry incision in the eye can be between 2.8 mm and 3.2 mm (see paragraph [0042]), a range that overlaps with the claimed ranges of 1.1 to 3.2 millimeters and less than 4 millimeters, all ranges in which have to do with the dimensions of the distal tip (injector) that is disclosed to be inserted into the incision in which the range overlaps with the claimed ranges. Due to this, the distal tip is also within the range of the incision of the eye, and 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 injector size from between 2.8 mm and 3.2 mm have the to disclose an inner diameter between 1.1 millimeters and 3.2 millimeters and the beveled first end have a bevel outer diameter that less is than 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]).
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Torres does teach a resilient member, but Torres fails to disclose the new claim 1 limitation wherein the elongated hollow body does not include any openings along its length, as well as the new limitation a deformable stopper disposed in the main body, wherein the stopper covers the entire outlet or the entire inlet, and a pressure actuated valve, and there would be no reason to modify Torres with elongated hollow body does not include any openings along its length and with a deformable stopper disposed in the main body, wherein the stopper covers the entire outlet or the entire inlet, as it does not have a pressure actuated valve.
US 20130165860 A1 (hereafter --Doud--):
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 end in Figure 30B below), and (iv) a second end having a second opening (see annotated injector second end in Figure 30B below); (b) a pressure actuated valve (700) that comprises a first portion configured for coupling to a syringe (see annotated first portion in Figure 30B below), a valve main body (see annotated valve main body in Figure 30B below), and a second portion in fluid communication with the injector second end (see annotated second portion in Figure 30B below). Doud teaches a valve that is pressure actuated (see annotated pressure actuated valve in Figure 30B below, see also paragraph [0246] denoting that the valve 700 can have a piece that opens under pressure and enables flow through the opening), and a deformable stopper disposed in the main body of the valve (see paragraph [0246] flow resistance structure, or “stopper”, 722 may be a duckbill valve or a flap with a spring, which are deformable).
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Doud fails to disclose the pressure actuated value is coupled to the elongated hollow body second end through a resilient member; and wherein (b) the resilient member comprises a channel extending from a first aperture to a second aperture; 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; and wherein (d) the resilient member is coupled to the elongated hollow body second end by extending the elongated hollow body second end partially through the resilient member second aperture and the elongated hollow body second end extends through the resilient member second aperture such that bulb is within the resilient member channel.
Conclusion
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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