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 view of the amendments to the claims filed 04/30/2025 in which claim 13 was amended, claims 1-15 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2020/054497 filed 02/20/2020 which claims priority to EP/19158258.4 filed on 02/02/2019.
Claims 1-15 receive priority to the prior-filed application, filed on 02/02/2019.
Response to Arguments
Claim Objections
The previous objections to the claims have been withdrawn in view of the amendments to the claims filed 02/13/2026.
Claim Rejections under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) have been withdrawn in view of the amendments to the claims filed 02/13/2026.
Claim Rejections under 35 U.S.C. 103
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Regarding claim 1, the applicant asserts on pg. 7-10 that the examiner refers to Fig. 1 of Chiang and submits that Fig. 15A-C and 8B illustrate the described embodiments of Chiang that are the best point of comparison with the claimed invention.
In response to the applicant’s argument, the examiner respectfully notes that in addition to referring to Ex. Fig. 1, the examiner refers to Fig. 18A-E of Chiang; therefore, the applicant’s arguments regarding other embodiments of Chiang do not overcome the rejection. Fig. 18A-E and the cited para. of Chiang provide enough disclosure of the relied upon embodiment, but the examiner provides Ex. Fig. 1 only to increase clarity.
Regarding claim 1, the applicant asserts on pg. 10-11, that the device of their invention has no need to use a special handle such as that described in Chiang, and that the device of their invention can advantageously be used universally for all types of DMEK surgeries.
In response to the applicant’s argument, the examiner respectfully notes that while the instant invention may be suitable for the situations the applicant describes, Chiang teaches or suggests all of the claimed limitations such that the claims are not patentable in view of Chiang.
Regarding claim 1, the applicant asserts on pg. 12 that the prior art to Chiang in combination with any of Tran, Ide, Bianchi, Shaknovich, and Schmidt, due to their distinctions from the instant invention, do not teach or suggest the limitations of the claimed invention.
In response to the applicant’s argument, the examiner respectfully disagrees. As explained above, the applicant’s arguments regarding other embodiments of Chiang do not overcome the rejection of the independent claim. Chiang alone teaches or suggests all of the limitations of the claimed invention.
The rejections of the claims are maintained.
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Ex. Fig. 1 of Chiang Fig. 18A-E
Claims 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2018/208729 A1 to Chiang.
Regarding claim 1, Chiang discloses a device for secure support storage and/or transport of a tissue graft for ophthalmological interventions (para. 0012-0013; Fig. 18A-E), comprising: a first opening (Ex. Fig. 1, first opening), a main body (Ex. Fig. 1, main body), a taper area (Ex. Fig. 1, taper area), and a second opening (Fig. 18A, second opening 702), characterized in that the first opening has a round shape (Ex. Fig. 1) and a funnel-like design configured to connect with a tube or a syringe (para. 0052-0053; Ex. Fig. 1) and the main body is transparent (para. 0054) and has a rectangle shape (Ex. Fig. 1) and the taper area is transparent (para. 0054) and has an elliptical, round, or biconvex shape (Ex. Fig. 1 showing taper area in a tapered rounded, elliptical shape), and wherein the main body comprises at least two flat and parallel opposite sides (Ex. Fig. 1); and wherein the taper area connects the main body with the second opening (Ex. Fig. 1).
Regarding the limitation “and is suitable for microscopic examination”, Chiang does not explicitly disclose this limitation, but it follows naturally that the structure recited in Chiang is suitable for microscopic examination. As stated in MPEP 2112.01 “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”. The examiner notes that Chiang discloses the main body being transparent (para. 0054) and having a main body comprising a rectangular portion (Ex. Fig. 1). The applicant’s specification notes that the transparency and rounded, rectangular shape of the main body permits microscopic examination (pg. 8 ln. 6-8); therefore, Chiang teaches the claimed invention.
Regarding claim 2, the cited prior art suggests the invention of claim 1. Chiang further discloses: wherein the second opening has an elliptical, round, biconvex or rounded rectangle shape (Ex. Fig. 1, second opening 702).
Regarding claim 3, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the outer wall of the second opening has a different shape than the inner wall.
Chiang discloses in a second embodiment an outer wall of a second opening that has a different shape than an inner wall to facilitate fluid transfer and easy movement of the graft in and out of the second opening (Fig. 8B, second opening 302 comprising groove 316; para. 0045).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the relied upon embodiment of Chiang to comprise a groove such that the outer wall of the second opening has a different shape than the inner wall in view of the second embodiment of Chiang, because Chiang teaches that the groove facilitates fluid transfer between the interior of the tip and its surrounding fluids during transport and that the groove is designed to allow for easy movement of the tri-folded graft into and out of the second opening (para. 0045).
Regarding claim 4, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose wherein the outer wall of the taper area has a different shape than the inner wall.
Chiang discloses in a second embodiment an outer wall of a taper area that has a different shape than an inner wall to facilitate fluid transfer and easy movement of the graft in and out of the second opening (Fig. 8B, second opening 302 comprising groove 316).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the relied upon embodiment of Chiang to comprise a groove such that the outer wall of the taper area has a different shape than the inner wall in view of the second embodiment of Chiang, because Chiang teaches that the groove facilitates fluid transfer between the interior of the tip and its surrounding fluids during transport and that the groove is designed to allow for easy movement of the tri-folded graft into and out of the second opening (para. 0045).
Regarding claim 7, the cited prior art suggests the invention of claim 1. Chiang further discloses: a cap for the first opening and/or a cap for the second opening (para. 0046-0048; Fig. 9A-11C, caps for use with the first and second openings of devices of the present invention).
Claims 5, 8, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang as applied above, and further in view of US/2018/0106704 A1 to Tran.
Regarding claim 5, the cited prior art suggests the invention of claim 1. Chiang further discloses: wherein the device consists of plastic (para. 0054), wherein said plastic is transparent (para. 0054).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the device consists of glass or wherein said plastic has a refractive index (ri) in the range of ri = 1.30 to ri = 1.71, which is similar to the ri = 1.33 to 1.34 (at 20 °C and 600 nm) of balanced salt solution (BSS), such as Hank's BSS, Earle's BSS, Tyrode's salt solution, Alsever's salt solution, phosphate-buffered saline (PBS), Tris-buffered saline (TBS), Puck's salt solution, Gey's salt solution, Ringer's salt solution, Simm's salt solution and related buffered saline solutions.
Tran teaches a tissue graft storage device formed from a biocompatible glass (para. 0035).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Chiang to consist of glass as taught by Tran, because Chiang discloses that their device can be formed from any other material that is biocompatible and known to or conceivable to one of skill in the art (para. 0054).
Regarding claim 8, the cited prior art suggests the invention of claim 1. Chiang further discloses: an assembly for loading, storage, and transport of a tissue graft or implant (para. 0012-0013; para. 0037; Fig. 18A-E), comprising:
the device according to claim 1 (as explained in the rejection of claim 1 above),
a tube (Fig. 17A-B, handle 620 as a tube with an open lumen; para. 0013), and
at least one cap (para. 0047-0048; Fig. 9A-11C, caps for use with the first and second openings of devices of the present invention).
The prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose a syringe.
Tran teaches an assembly for transporting a tissue graft comprising at least one syringe such that actuation of the syringe fluidly connected to a tube delivers the graft from the device (Fig. 4, syringe 340 fluid connected to tube 345 and device 320; para. 0066).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of Chiang to further comprise a syringe to provide fluid through the tube as taught by Tran, because Tran teaches that the actuation of a syringe fluidly connected to a tube delivers the graft from the device (para. 0066).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Chiang further discloses: a method for preparing a tissue graft or implant using the device according to claim 1 (as explained in the rejection of claim 1 above), comprising the steps:
a) providing a tissue graft or implant (para. 0012-0015),
b) loading the tissue graft or implant into the device (para. 0012-0015),
c) sealing the device by at least one cap (para. 0047-0048; Fig. 9A-11C, caps for use with the first and second openings of devices of the present invention),
d) evaluation and quality control of the tissue graft or implant inside the device (para. 0054),
e) transport of the device with the tissue graft or implant (para. 0012-0015),
f) optional evaluation and quality control of the tissue graft or implant inside the device (para. 0054),
g) washing of the tissue graft or implant inside the device (para. 0012-0015; para. 0054).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose staining of the tissue graft inside the device.
Tran teaches staining of a tissue graft inside a device to lower the risk of unnecessary damage to the graft (para. 0065; para. 0072; para. 0085; Fig. 11).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method for preparing a tissue graft of Chiang to comprise staining of the tissue graft inside the device as taught by Tran, because Tran teaches that staining provides visibility to the graft after injection into donor eyes to determine successful opening (para. 0082) and that staining the graft outside of the device requires replacing the graft in the device, potentially causing unnecessary damage to the graft (para. 0072).
Regarding claim 14, the cited prior art suggests the method of claim 13; however, the current combination of the prior art differs from the instantly claimed invention in that the current combination fails to disclose wherein the device is transported within a device holder.
Tran teaches transporting the device within a device holder to decrease fluid loss (para. 0057; Fig. 1B showing corneal tissue carrier 120 sealed within viewing chamber 110).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of the current combination of Chiang and Tran to further comprise transporting the device within a device holder as taught by Tran, because Chiang’s disclosure of their device clearly contemplates the movement of fluid from within the device to outside of the device through the cap (para. 0046), and Tran teaches that transporting the device within a device holder decreases fluid loss (para. 0057), allowing for the movement of fluid from within the device to outside of the device without leaking or causing the graft within the device to dry.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang and Tran as applied above, and further in view of EP/2111821 A1 to Ide.
Regarding claim 6, the cited prior art suggests the invention of claim 5.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the inner surface of the device comprises a hydrophobic coating, selected from coatings comprising acrylate, organo-siloxane, silane, epoxy, a polymer, Molybdenum disulfide, Molybdenum disulfide/graphite, Tungsten disulfide or graphite, preferably selected from coatings comprising a polymer, organo-siloxane, silane, acrylate or epoxy; or
a hydrophilic coating, selected from coatings comprising any hydrophilic polymer/hydrogel, preferably selected from coatings comprising poly(ethylene glycol), poly(acrylate), poly(methacrylate) or a UV/photo-active polymer; and/or
a surface patterning, being a micro- or nanostructured surface pattern or a combination thereof (e.g. nano-microstructuring) in the range of 100 nm to 20000 nm, preferably between 300 nm to 5000 nm and more preferably between 500 nm to 2500 nm.
Ide teaches an injector for an graft that comprises a hydrophobic or hydrophilic coating on the inner surface to increase the slidability of the graft (para. 0022; para. 0037; para. 0093; para. 0102 ln. 49-50).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the inner surface of the device of Chiang and Tran to comprise a hydrophobic or hydrophilic coating as taught by Ide, because Ide teaches that such a coating increases the slidability of the graft, such that the graft can be easily pushed out of the injector and sudden damage to the graft can be effectively prevented (para. 0037; para. 0093).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang and Tran as applied above, and further in view of US/2017/0165108 A1 to Bianchi.
Regarding claim 9, the cited prior art suggests the invention of claim 8; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a transport device.
Bianchi teaches a transport device to initially store an implant and to allow for controlled interface with a syringe (Fig. 6, transport device 105; para. 0053-0054).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of Chiang and Tran to teach the transport device as taught by Bianchi to initially store an implant prior to implantation and to allow for controlled interface with a syringe (para. 0053-0054).
Regarding claim 10, the cited prior art suggests the invention of claim 9. Bianchi further discloses: wherein the transport device is a device holder (Fig. 6; para. 0053-0054) comprising:
a round neck (Fig. 6, guide sleeve 120 as a round neck; Fig. 4b; para. 0056) with a holder (Fig. 4b showing concave portion of guide sleeve 120 as a holder),
finger tips (Fig. 3b, tabs 405 of guide sleeve 101, which is part of the transport device 105; para. 0056; para. 0066-0067) which are attached on an oval shaped platform with a cavity (Fig. 6 body of transport device 105 which has a rounded, oval-like shape and a recess to receive a device); and
a tilted stripe (Fig. 4B, tab 123; para. 0068), which is suitable to be positioned inside a container (intended use; transport device 105 fully suitable to be positioned in a container).
Regarding claim 11, the cited prior art suggests the invention of claim 10, the combination further discloses: wherein the fingertips and the oval shaped platform with a cavity do not optically interfere with the main body and the taper area of the device (as explained below).
Bianchi’s transport device provides an opening that does not obscure an implant holder (Fig. 6, implant holder 125 in transport device 105). As the platform and fingertips do not entirely cover or alter the device holder and device, it would be understood that these elements would not optically interfere with the main body and taper area of the device.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang, and further in view of US/2018/0106704 A1 to Tran and WO/9908744 A1 to Shaknovich.
Regarding claim 12, the cited prior art suggests the invention of claim 1.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose a washing assembly for washing and staining a tissue graft or implant comprising a macroporous material with interconnected pores and a porosity between 20-2000 µm, and at least one syringe.
Tran teaches a washing assembly for washing and staining a tissue graft or implant (para. 0065; para. 0072; para. 0085; para. 0099; Fig. 11) comprising:
a macroporous material with interconnected pores and a porosity between 20-2000 µm (para. 0049, caps 228a-b comprised of macroporous materials with openings of 0.02-2 mm = 20-2000 µm; fluid passage is allowed through the cap; therefore, the pores must be interconnected),
a device for secure support storage and/or transport of a tissue graft (Fig. 1A, storage device 120), and
at least one syringe (para. 0099; Fig. 4, syringe 340), wherein staining provides visibility to the graft after injection into the donor eyes (para. 0082).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Chiang to further comprise the washing and staining assembly as taught by Tran, because Tran teaches that staining provides visibility to the graft after injection into donor eyes to determine successful opening (para. 0082) and that staining the graft outside of the device requires replacing the graft in the device, potentially causing unnecessary damage to the graft (para. 0072).
Further, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose the porosity between 10-600 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of the macroporous material of Chiang and Tran from between 20-2000 µm to between 10-600 µm as applicant appears to have placed no criticality on the claimed range (see pg. 29 ln. 4-6 indicating the porosity is between these values and preferably between other values) and since it has been held that “[i]n 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 still, the prior art differs from the instantly claimed invention in that the prior art fails to disclose a 2-way extension line or a 3-way stopcock.
Shaknovich teaches a 3-way stopcock in a washing assembly for a tissue graft to allow for the provision of multiple wash fluids (pg. 11 ln. 9-11; pg. 11 ln. 23-25).
Shaknovich is considered to be analogous to the instantly claimed invention in that Shaknovich discloses an assembly for washing tissue grafts. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the washing assembly of Chiang and Tran to comprise a 3-way stopcock as taught by Shaknovich, because Shaknovich teaches that this allows for multiple wash fluids to be provided to the graft (pg. 11 ln. 23-25).
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang and Tran as applied above, and further in view of US/2006/0110721 A1 to Schmidt.
Regarding claim 15, the cited prior art suggests the method of claim 13. Chiang further discloses: wherein evaluation and quality control of the tissue graft or implant is performed (para. 0054).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein evaluation and quality control of the tissue graft or implant is performed with the device containing the tissue graft or implant being inside a transport device and inside a container.
Schmidt teaches a method for preparing a tissue implant comprising performing evaluation and quality control of the tissue implant inside a transport device and inside a container (para. 0038) to prevent the assembly from moving out of position for viewing in a vertical and a horizontal position (para. 0038).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Chiang and Tran to comprise performing evaluation and quality control inside a transport device and inside a container as taught by Schmidt, because Schmidt teaches that this arrangement prevents the assembly from moving out of position for viewing in a vertical and a horizontal position (para. 0038).
Conclusion
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 28 May 2026
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