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 .
Status of Claims
Claims 1 and 3-22 are pending and examined on the merits.
Claims 1, 3, 4, 8, 11-13, 18, and 22 are currently amended.
Claim 2 is cancelled.
Response to Amendment
Applicant amendments filed 09/24/2025 have been fully considered.
Response to Arguments
Applicant provided amendments to the independent claim which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 09/24/2025 have been fully considered but they are moot. Hughes (U.S. Patent No. 5,962,027 A), Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), Hee (U.S. Pre Grant Pub. No. 2010/0173866), Haffner (U.S. Pre Grant Pub. No. 2014/0303544), Yamamoto (U.S. Pre Grant Pub. No. 2018/0250224), Holmen (U.S. Pre Grant Pub. No. 2006/0155301 A1), and Kosar (U.S. Pre Grant Pub. No. 2017/0072138 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the claimed limitations submitted via the 09/24/2025 amendments.
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 (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.
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.
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.
Claims 1, 3, 5-6, 8-10, 12, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Patent No. 5,962,027 A), in view of Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), and further in view of Haffner (U.S. Pre Grant Pub. No. 2014/0303544 A1).
Regarding claim 1, Hughes teaches: A device for delivery of material (see at least Abstract) comprising:
a stacked pair of thin, elongate strips of flexible material (see top 32a/lumen 42/ fiber optic filament 64 and bottom 32b in Fig. 15; see also col. 8, lines 62-64 describing an elongate tube 32 having a flat, wide cross-section; as shown in Figs. 14 and 15, the elongate strips are stacked on top of one another);
wherein the stacked pair of thin, elongate strips of flexible material form a flexible, expandable tube (see tube 32 at least in Fig. 14; col. 8, lines 59-61 teaches that the instrument 30 may be made of a flexible material; therefore, the tube is also flexible and is therefore expandable), wherein an elongate lumen is defined between the stacked pair of thin, elongate strips of flexible material (as shown in at least Figs. 14-15, and as described in at least col. 9, lines 48-53, tube 32 defines a lumen through which plunger 40 is slidably received);
wherein the stacked pair of thin, elongate strips of flexible material are formed from a flexible material that allows the device to curve along the subretinal space (see at least col. 8, lines 59-61 and Figs. 19-20; as broadly claimed, the device is not required to be straight prior to use; rather, the claim merely requires that the pair of thin, elongate strips are formed of flexible material - which is taught by Hughes at least in col. 8, lines 59-61 - and that the pair of thin, elongate strips are capable of curving along a subretinal space - due to their flexibility, the device of Hughes is also capable of curving along a subretinal space).
However, Hughes fails to explicitly teach a thin layer of elastic material surrounding the pair of thin, elongate strips of flexible material or that the pair of thin, elongate strips are discontinuous, as required by the claim.
Badawi teaches an analogous device for accessing an eye for delivering a fluid composition therein (see Abstract) comprising a cannula that is advanced through an eye wall and anterior chamber (see para. [0058]). Badawi further teaches that it is advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during the procedure (see para. [0058]) and that the lubricious polymers can include polytetrafluoroethylene (PTFE) (see para. [0058]), which is elastic.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hughes to incorporate the teachings of Badawi by coating the pair of thin, elongate strips of flexible material with a lubricious and elastic coating at least to reduce friction between the ocular tissue and the tube during the procedure, as taught by Badawi (see para. [0058]).
However, Hughes in view of Badawi fails to explicitly teach that the pair of thin, elongate strips are discontinuous, as required by the claim.
Haffner teaches an analogous device for the delivery of material to an eye (see at least para. [0009]) comprising advancing a device into the sclera and/or the choroid (see at least para. [0033]). Haffner further teaches that outer shell 54 is discontinuous (as broadly recited, discontinuous is defined as having intervals or gaps; as shown in Fig. 8 and as described in para. [0173], the shell 54 comprises one or more orifices 56a that pass through the shell 54).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hughes in view of Badawi by making the strips discontinuous by having one or more orifices 56a pass through the strips at least in order to allow for drainage of ocular fluid from the eye chamber, as taught by Haffner (see para. [0061]).
Regarding claim 3, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein a top strip of the discontinuous pair of thin, elongate strips includes cutouts to aid in a separation of the discontinuous pair or thin, elongate strips (as broadly claimed, a first cutout is located at the distal end 34 of tube 32 and a second cutout is located at distal end 44 of lumen 42).
Regarding claim 5, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein the elongate lumen is configured for dispensing material or cells through the device (see at least col. 4, lines 8-11).
Regarding claim 6, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein a geometry of the device is configured such that the device is extremely flexible in a first bending direction, but more rigid in a second bending direction (as shown in Figs. 2B and 2D of Applicant’s disclosure, a flexible bending direction is interpreted as a direction away from the lumen 110 and towards either of the pair of thin, elongate strips of flexible material 104, 106, while a rigid bending direction is interpreted as a direction towards the longitudinal sides of the delivery device; the device of Hughes also functions the similarly, for example, the instrument 30 is more flexible in a direction toward the top 32a and 32b than in a direction toward the opposing sides 32c and 32d; see at least Figs. 14-15).
Regarding claim 7, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes nor Badawi explicitly teach an optical coherence tomography sensor, as required by the claims.
Haffner teaches an analogous device for the delivery of material to an eye (see at least para. [0009]) comprising advancing a device into the sclera and/or the choroid (see at least para. [0033]). Haffner further teaches the use of an optical coherence tomography (OCT) sensor for visualization of an entry point of the device, such that a user can determine a depth of penetration of the device at entry (see para. [0337]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes in view of Badawi to incorporate the teachings of Haffner by including an OCT sensor at least because Haffner teaches that in order to avoid penetration of the choroid, scleral thickness can be measured using an OPT sensor (see para. [0337]).
Regarding claim 8, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches further comprising a distal end of the discontinuous pair of thin, elongate strips of flexible material having a rounded shape (as shown in at least Fig. 15, the distal end 44 of the lumen 42 has a rounded shape).
Regarding claim 9, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein the device is configured to move through a subretinal space of an eye (see for example Figs. 19-20).
Regarding claim 10, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein the device is configured to deliver cells to a retina (see for example col. 1, lines 10-12).
Regarding claim 12, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches wherein the discontinuous pair of thin, elongate strips of flexible material are formed from a material that allows the passage of objects between the pair of thin, elongate strips of flexible material (col. 9, lines 49-53 disclose that the tube 32 contains a planar cellular structure that is urged out of the distal end of the tube; therefore, the pair of thin, elongate strips of flexible material are formed from a material that allows passage of objects).
Regarding claim 14, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. Additionally, Hughes teaches further comprising a hub for facilitating the injection of material or cells to the retina (see connector 48 in Figs. 10-12 and col. 10, lines 18-20).
Regarding claim 18, Hughes teaches: A method of delivering material to a retina (see at least Abstract) comprising:
accessing a subretinal space (see for example Figs. 19-20);
visualizing the subretinal space (see at least col. 10, lines 50-51); and
depositing material in the subretinal space (see at least col. 1, lines 9-15) using a pair of thin, elongate strips of flexible material (see top 32a and bottom 32b in Fig. 15; see also col. 8, lines 62-64 describing an elongate tube 32 having a flat, wide cross-section) to form a flexible, expandable tube (see tube 32 at least in Fig. 14; col. 8, lines 59-61 teaches that the instrument 30 may be made of a flexible material; therefore, the tube is also flexible and is therefore expandable), wherein an elongate lumen extends between the pair of thin, elongate strips of flexible material (as shown in at least Figs. 14-15, and as described in at least col. 9, lines 48-53, tube 32 defines a lumen through which plunger 40 is slidably received) for depositing the material (see at least col. 1, lines 9-15);
wherein the pair of thin, elongate strips of flexible material are formed from a flexible material that allows the device to curve along the subretinal space (see at least col. 8, lines 59-61 and Figs. 19-20; as broadly claimed, the device is not required to be straight prior to use; rather, the claim merely requires that the pair of thin, elongate strips are formed of flexible material - which is taught by Hughes at least in col. 8, lines 59-61 - and that the pair of thin, elongate strips are capable of curving along a subretinal space - due to their flexibility, the device of Hughes is also capable of curving along a subretinal space).
However, Hughes fails to explicitly teach a thin layer of elastic material surrounding the pair of thin, elongate strips of flexible material or that the pair of thin, elongate strips are discontinuous, as required by the claim.
Badawi teaches an analogous method for accessing an eye for delivering a fluid composition therein (see Abstract) comprising a cannula that is advanced through an eye wall and anterior chamber (see para. [0058]). Badawi further teaches that it is advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during the procedure (see para. [0058]) and that the lubricious polymers can include polytetrafluoroethylene (PTFE) (see para. [0058]), which is elastic.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hughes to incorporate the teachings of Badawi by coating the pair of thin, elongate strips of flexible material with a lubricious and elastic coating at least to reduce friction between the ocular tissue and the tube during the procedure, as taught by Badawi (see para. [0058]).
However, Hughes in view of Badawi fails to explicitly teach that the pair of thin, elongate strips are discontinuous, as required by the claim.
Haffner teaches an analogous device for the delivery of material to an eye (see at least para. [0009]) comprising advancing a device into the sclera and/or the choroid (see at least para. [0033]). Haffner further teaches that outer shell 54 is discontinuous (as broadly recited, discontinuous is defined as having intervals or gaps; as shown in Fig. 8 and as described in para. [0173], the shell 54 comprises one or more orifices 56a that pass through the shell 54).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hughes in view of Badawi by making the strips discontinuous by having one or more orifices 56a pass through the strips at least in order to allow for drainage of ocular fluid from the eye chamber, as taught by Haffner (see para. [0061]).
Regarding claim 19, Hughes, in view of Badawi, and further in view of Haffner teaches the method as discussed above in claim 18. However, neither of Hughes nor Badawi explicitly teach an optical coherence tomography sensor, as required by the claims.
Haffner teaches an analogous device for the delivery of material to an eye (see at least para. [0009]) comprising advancing a device into the sclera and/or the choroid (see at least para. [0033]). Haffner further teaches the use of an optical coherence tomography (OCT) sensor for visualization of an entry point of the device, such that a user can determine a depth of penetration of the device at entry (see para. [0337]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined method of Hughes in view of Badawi to incorporate the teachings of Haffner by including an OCT sensor at least because Haffner teaches that in order to avoid penetration of the choroid, scleral thickness can be measured using an OPT sensor (see para. [0337]).
Regarding claim 20, Hughes, in view of Badawi, and further in view of Haffner teaches the method as discussed above in claim 18. Additionally, Hughes teaches further comprising accessing the subretinal space via an incision in the sclera and choroid (see for example col. 11, lines 22-25).
Regarding claim 22, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 22. However, neither of Hughes nor Badawi explicitly teach that the discontinuous pair of thin, elongate strips of flexible material are straight prior to use, as required by the claim.
Haffner teaches that the implant is flexible enough to be contained within the straight lumen of a delivery device (see para. [0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hughes, in view of Badawi, and further in view of Haffner to further incorporate the teachings of Haffner by pre-straightening the device prior to use at least because the Haffner teaches that the implants may be pre-flexed (see para. [0150]) while Hughes teaches that the instrument is made from a flexible material (see col. 8, lines 1-5) and one of ordinary skill in the art would have reasonably recognized that the device can be pre-straightened prior to use, as taught by Haffner (see para. [0150]).
Claims 4, 15-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Patent No. 5,962,027 A), in view of Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), further in view of Haffner (U.S. Pre Grant Pub. No. 2014/0303544 A1), as applied above to claim 1, and further in view of Hee (U.S. Pre Grant Pub. No. 2010/0173866).
Regarding claim 4, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes, Badawi, nor Haffner explicitly teach that the bottom strip of the pair of thin, elongate strips includes markings to allow a length of insertion to be measured, as required by the claim.
Hee teaches an analogous device to surgically access the suprachoroidal space of an eye comprising a flexible tubular sheath/microcannula device (see at least para. [0007]). Hee further teaches that the microcannula device may comprise markings on the exterior for assessment of depth in the suprachoroidal space (see at least para. [0007]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Hee by including markings on the bottom strip of the pair of thin, elongate strips at least in order to enable a user to assess the depth of the delivery device within an eye, as taught by Hee (see para. [0032]).
Regarding claims 15-16, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 14. Additionally, Hughes teaches a connector/hub 48 for connection to a source of fluid (see col. 10, lines 18-20). However, neither Hughes, Badawi, nor Haffner explicitly teach that the hub can include a reservoir that takes the form of a syringe, as required by the claim.
Hee teaches that a syringe can be used to introduce fluids or materials into a microcannula that is disposed in an eye (see for example para. [0015, 0042] and Fig. 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Hee by including a syringe as a reservoir for the material or cells at least in order to provide sustained delivery of material or cells to the distal end of the device in order to treat the eye, as taught by Hee (see para. [0042]).
Regarding claim 21, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes, Badawi, nor Haffner explicitly teach that the device has a thickness between about 0.02mm and about 0.05mm, as required by the claim.
Hee teaches a microcannula device with a wall thickness from about 10-200 microns (0.01mm to 0.2mm; see para. [0031]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Hee by making the device have a thickness between about 0.02mm and about 0.05mm at least because Applicant has not specified the criticality of such values and since it has been held that where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see also MPEP 2144.05(I). In the instant case, since the claimed ranges overlap or lie inside the ranges disclosed by Hee, such claimed ranges are considered to be obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Patent No. 5,962,027 A), in view of Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), further in view of Haffner (U.S. Pre Grant Pub. No. 2014/0303544 A1), as applied above to claim 1, and further in view of Holmen (U.S. Pre Grant Pub. No. 2006/0155301 A1).
Regarding claim 11, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes, Badawi, nor Haffner explicitly teach that the pair of thin, elongate strips of flexible material further define holes for fixation of the device to an eye, as required by the claim.
Holmen teaches an analogous device to be introduced into an eye comprising a tube 12 and a lumen 14 (see Abstract). Holmen further teaches fixation means 29 for temporary fixation of the device to the eye having holes for sutures (see para. [0107]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Holmen by including holes for fixation of the device to an eye at least in order for a suture to be easily attached for fixation by some stitches to the scleral region of the eye, as taught by Holmen (see para. [0107]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Patent No. 5,962,027 A), in view of Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), further in view of Haffner (U.S. Pre Grant Pub. No. 2014/0303544 A1), as applied above to claim 1, and further in view of Yamamoto (U.S. Pre Grant Pub. No. 2018/0250224).
Regarding claim 13, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes, Badawi, nor Haffner explicitly teach a lubricating material disposed between the pair of thin, elongate strips of flexible material, as required by the claim.
Yamamoto teaches an analogous device for the delivery of material to an eye (see at least Abstract) comprising an elongated barrel with a hollow needle having a lumen (see at least para. [0012]). Yamamoto further teaches that the needle lumen can be coated by a lubricant (see para. [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Yamamoto by placing a lubricating material disposed between the pair of thin, elongate strips of flexible material to facilitate smooth passage and prevent adhesion of the material to be delivered at least because Yamamoto teaches that a lubricant may be used to aid injection by coating the tip of the distal end of the device as it passes into tissue (see para. [0077]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes (U.S. Patent No. 5,962,027 A), in view of Badawi (U.S. Pre Grant Pub. No. 2013/0253438 A1), further in view of Haffner (U.S. Pre Grant Pub. No. 2014/0303544 A1), as applied above to claim 1, and further in view of Kosar (U.S. Pre Grant Pub. No. 2017/0072138 A1).
Regarding claim 17, Hughes, in view of Badawi, and further in view of Haffner teaches the invention as discussed above in claim 1. However, neither of Hughes, Badawi, nor Haffner explicitly teach a microfluidic platform to lift the product of the injector using a "no-touch" technique.
Kosar teaches an analogous pharmaceutical drug delivery system for delivery of drugs through the ocular route (see Abstract and para. [0004]) by means of a micro electro mechanical system (MEMS) which is a microfluidic drug delivery system (see para. [0025, 0044]). Kosar further teaches that the microfluidic drug delivery system stores a final fluid mixture for delivery using an injector, i.e., using a no-touch technique (see para. [0044]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device of Hughes, in view of Badawi, and further in view of Haffner to incorporate the teachings of Kosar by including a microfluidic platform to lift the product of the injector using a no-touch technique at least in order to provide a safe manner for precision amounts of drug/material/cells to be delivered, as taught by Kosar (see para. [0010] describing a deficiency in the prior art that is a primary object of Kosar to overcome; see also para. [0012]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781