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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to ophthalmic tissue delivery apparatus, classified in A61F2/148.
II. Claim 17, drawn to method for storing ophthalmic tissue , classified in A61F2/0095.
III. Claims 18-20, drawn to a method for performing endothelial keratoplasty, classified in A61F2/142.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the apparatus of Group I can be used to store tissue with other methods than the method of Group II, for example, the apparatus can store the tissue without the step transporting the injector and carrier to another site.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the apparatus of Group I can be used perform a keratoplasty with other methods than the method of Group III, such as a method without the step of ensuring the beveled end occupies the entire incision or without ensuring the bevel faces upward away from the patient.
Inventions II and III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed describe processes that have a materially different function, as Group II is describing a method in which the tissue is loaded and transferred to the operation site, and Group III is describing a method of performing the operation using the apparatus. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Even though the search strategies for Groups I, II, and III may overlap, a search for a surgical deployment method using the device and a method of loading tissue involves different text queries than a search for the delivery device itself. Additionally, different search queries, different search strategies and different areas of search are required for each different group as claimed.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Samantha Regala on 02/03/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-5 and 7 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);
(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, 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 is between .4 millimeters and .8 millimeters and the interior width is between 2 millimeters and 4 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 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 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]).
Szurmann further fails to disclose wherein the interior thickness is between 0.4 millimeters and 0.8 millimeters.
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 (see annotated chamber in Figure 15A 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 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 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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Regarding Claim 2, Szurmann as modified discloses the delivery apparatus of claim 1.
Szurmann as modified fails to discloses 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 3, Szurmann as modified discloses the delivery apparatus of claim 1, further comprising a pressure actuated valve, wherein the pressure actuated valve comprises:(a) a first portion configured for coupling to a syringe (see annotated syringe and first portion in Figure 12 above); (b) a valve main body (see annotated valve main body in Figure 12 above); (c) a deformable stopper disposed in the main body, and (d) a second portion in fluid communication with the injector second end (see annotated stopper and second portion in Figure 12 above).
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 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 wherein (a) the chamber 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 a chamber inner surface; and(b) 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 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).
Claims 8-11 and 13-16 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--), in view of US 20200060808 A1 (hereafter –Chiang--).
Regarding Claim 8, 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 first conduit, first opening, and beveled first end in Figure 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 is wider than the first conduit and wider than 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.
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).
Szurmann further fails to disclose the chamber comprising a flattened, hollow body that is wider than the first conduit and wider than 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 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 and wider than the second 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).
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 15, Szurmann as modified discloses the delivery apparatus of claim 13, wherein the pressure actuated value comprises: (a) a first portion 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 deformable stopper disposed in the main body (see annotated stopper in Figure 12 above); and (d) a second portion coupled to the second end of the second conduit (see annotated second portion 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).
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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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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774