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 the Claims
The claims filed 08/15/2024 has been entered. Claims 1-14 are pending and under consideration.
Drawings
The drawings are objected to because the reference numerals used in the drawings do not clearly and consistently identify the corresponding elements of the claimed invention. For instance, reference numerals 211 and 212 appear to identify the same passage, i.e., figure 6, or portions of a passage, but it is unclear from the drawings whether the numerals refers to the same element or to different elements. Further, reference numerals 23 and 24 appear to point the same portion of the Tesla valve segments in the drawing, while the specification describes numerals 23 and 24 as referring to different elements, i.e., specification [0037-0040] Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-14 recite “the corneal path unidirectional aqueous humor drain” in preamble, which should read “the corneal path unidirectional aqueous humor drainage device”
Claims 6 and 7 recite “the liquid inlet the diameter of the mouth and liquid outlet” which should read “the diameter of the inlet port and the diameter of the outlet port”
Claim 9 line 3 recites “humor drain” which should read “humor drainage device”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-4, 6, 7, 9, 10, 11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 line 2 recites “it” and it is not clear what “it” refers to. For the purpose of examination, the limitation is being interpreted as “the corneal path unidirectional aqueous humor drainage device”
Claim 2 line 4 recites “an outlet port at one end”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “an outlet port at an opposite end”
Claim 3 line 2 recites “said group of Tesla valve units” There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “said Tesla valve unit group”
Claim 3 lines 4-7, “said second passageway comprising a second inlet portion and a second outlet portion connected to each other, with one end of said second inlet portion and said second outlet portion of said second inlet portion and second outlet portions respectively”. It is not clear what “with one end of said second inlet portion and said second outlet portion of said second inlet portion and second outlet portions respectively” means. For the purpose of examination, the limitation is being interpreted as “said second passageway comprising a second inlet portion and a second outlet portion connected to each other”
Claim 3 recites in line 8, “the inlet end”, in line 10 “the outlet end”, in line 12 “the angle”. There are insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitations are being interpreted as “an inlet end”, “an outlet end” and “an angle”
Claim 3 lines 13-14 “between said second inlet portion and said first channel and the second outlet portion and said second outlet portion and said first channel”. It is not clear what it means. for the purpose of the limitation is being interpreted as “between said second out portion and said first channel”
Claim 4 lies 3-4 recite “with the outlet end of one of said Tesla valve units and the inlet end of the other of said Tesla valve unit of said adjacent Tesla valve units”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “with the outlet end of said Tesla valve unit and the inlet end of the adjacent Tesla valve unit being located on either side of the segment”
Claims 6 and 7 recite “the base body” There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “the substrate”
Claim 9 line 2 “the outer side wall” There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “an outer side wall”
Claim 10 recites in line 4 “said axial direction”, in line 5 “said side portion”, in line 6 “said middle portion”. There are insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation is being interpreted as “an axial direction”, “a side portion”, “a middle portion”
Claim 10 recites “so that said substrate is arranged along said substrate: it is not clear what it means”. Clarification is required.
Claim 11 recites “characterized in that a biocompatible material is used”, it is not clear what it means. for the purpose of examination the limitation is being interpreted as “the drainage device comprises a biocompatible material.
Claim 14 recites “the light-curing biocompatible material includes triethoxybisphenol A dimethacrylate, bisphenol A epoxy methacrylate Any one of polyacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate-modified gelatin, and (meth)acrylate-modified hyaluronic acid.” It is not clear if the claim refers the light-curing biocompatible material includes all of the recited material or refers the light-curing biocompatible material includes any one of triethoxybisphenol A dimethacrylate, bisphenol A epoxy methacrylate, polyacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate-modified gelatin, and (meth)acrylate-modified hyaluronic acid. For the purpose of the examination, the limitation is being interpreted as the light-curing biocompatible material includes any one of claimed material above.
Examiner’s note: The above noted informalities should not be taken as an exhaustive list of all such instances. Therefore, it is requested that Applicant review the claims in their entirety for compliance with 35 U.S.C. 112(b)
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 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.
Claims 1-5, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sponsel et al (US 20220062044 A1) in view of Siebert (US 20220403838 A1).
Regarding claim 1, Sponsel substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A corneal path unidirectional atrial aqueous drainage device (figure 1, elongate member 1) characterized in that said corneal path unidirectional atrial aqueous drainage device has a Tesla valve unit group inside said corneal path unidirectional atrial aqueous drainage device, said Tesla valve unit group being constructed as a drainage channel; said drainage channel being a unidirectional drainage for drainage of atrial aqueous from the eye to the ocular surface.
Sponsel does not teach the drainage device comprising a Tesla valve unit group inside said corneal path unidirectional atrial aqueous drainage device, said Tesla valve unit group being constructed as a drainage channel; said drainage channel being a unidirectional drainage for drainage of atrial aqueous from the eye to the ocular surface.
Sibert teaches a flow control valve (figures 1a-c and [0018-0020] tesla valve 100), which relatively pertinent to the problem posed by the applicant of suppressing reverse flow, comprising a Telsa valve unit group (figure 1a, plurality of segments 118) inside said corneal path unidirectional atrial aqueous drainage device, said Tesla valve unit group being constructed as a drainage channel ([0018-0020] the tesla valve is configured to facilitate forward flow 112 while suppressing reverse flow 114, thereby facilitating drainage of fluid from the forward side ); said drainage channel being a unidirectional drainage for drainage of atrial aqueous from the eye to the ocular surface ([0018-0020], suppressing reverse flow).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, to incorporate the teachings of Siebert and provide the tesla valve unit group as claimed for the purpose of providing unidirectional drainage without moving parts thereby providing maintenance free fluidic diode behavior as taught by Sibert ([0018]).
Regarding claim 2, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 1.
The combination further teaches characterized in that the corneal path unidirectional aqueous humor drainage device comprises a substrate (Sibert; body of valve 100) having a first side portion (Sibert; annotated figure 1a, first side) and a second side portion (Sibert; annotated figure 1a, second side) connected to each other, and said Tesla valve unit group (Sibert; segments 118 within the valve body 100); said first side portion having an inlet port at one end (Sibert; annotated figure 1a, inlet of the flow path at an end of the first side), and said second side port having an outlet port at an opposite end (Sibert; annotated figure 1a, outlet of the flow path 124 at an opposite end in the second side), and said Tesla valve unit group running through said first side portion and said second side portion, and connected to said inlet port and outlet port (Sibert; annotated figure 1a, the segments 118 of the tesla valve running through the first and second sides) When liquid flows into said Tesla valve unit group from said outlet port, said Tesla valve unit group is capable of blocking the flow of liquid to said inlet port (Sibert; [0018-0020]).
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Regarding claim 3, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 1.
The combination further teaches characterized in that said Tesla valve unit group comprises a plurality of Tesla valve units (Sibert; figure 1a, segments 118 connected in series) connected in series with each other, each of said Tesla valve units comprising a first passageway (Sibert; figure 1b, forward flow path 122) and a second passageway (Sibert; figure 1b, reverse flow path 126) disposed on a radial side of said first passageway; said second passageway comprising a second inlet portion (Sibert; annotated figure 1b, second inlet) and a second outlet portion (Sibert; annotated figure 1b, second outlet) connected to each other, said second inlet portion being connected to said first channel (Sibert; annotated figure 1b, the reverse flow path 126 connected to the forward flow path 122), said second outlet portion being connected to said first channel being constructed as an inlet end of said Tesla valve unit (Sibert; annotated figure 1b, the portion where the second inlet merged into forward flow path 122), said second outlet portion being connected to said first channel being constructed as an outlet end of said Tesla valve unit (Sibert; annotated figure 1b, portion of the flow path where the second outlet merged into the forward flow path 122), said second inlet portion and second outlet portion being angularly disposed with respect to said first channel respectively (Sibert; figures 1a-b and [0019] tortuous loops 116 angularly disposed with respect to the forward flow path 122), and said second inlet portion having an angle (Sibert; annotated figure 1b, inlet angle) of disposition with respect to said first channel greater than an angle (Sibert; annotated figure 1b, outlet angle, the inlet angle being greater than the outlet angle) of disposition between said second outlet portion and said first channel. The angle between said second inlet portion and said first channel is greater than the angle between said second outlet portion and said first channel, so that when liquid enters said Tesla valve unit from said outlet end, liquid flowing from said second inlet portion is able to block the flow of liquid in said first channel (Sibert; figure 1b, and [0018-0020] the inlet angle being greater than the outlet angle, and the construction facilitates the reverse flow 128 through the reverse flow path 126 blocks the reverse flow 128 through the forward flow path 122).
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Regarding claim 4, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 3.
The combination further teaches characterized in that said first passages of adjacent said Tesla valve units have mutually overlapping segments (Sibert; figures 1a-b, the segments 118 are arranged in an overlapping manner such that at least portion of the forward flow path 122 serves as both the outlet of one segment and the inlet of an adjacent segment), with the outlet end of said Tesla valve unit and the inlet end of the adjacent Tesla valve unit being located on either side of the segment (Sibert; figures 1a-b, the segments 118 are arranged in a series such that the inlet end of the adjacent tesla located on both side of each segment); said second passages of said Tesla valve units of said adjacent Tesla valve units being opposed to each other. said second channels of said adjacent Tesla valve units are opposed to each other (figure 1b, the reverse flow path 126 of adjacent tesla valve units are opposed to each other along the longitudinal axis of the tesla valve 100).
Regarding claim 5, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 3.
The combination further teaches characterized in that said first channel of each said Tesla valve unit comprises a first inlet portion (Sibert; annotated figure 2, first inlet) and a first outlet portion (Sibert; annotated figure 1b, first outlet) which are connected to each other; said first inlet portion and said first outlet portion of each said Tesla valve unit having an angle to each other (figure 1b, the first inlet and first outlet are angled);
wherein said Tesla valve units in close proximity to each other: the first outlet portion of one said Tesla valve unit overlaps with the first inlet portion of the adjacent Tesla valve unit (figures 1a-b, the segments 118 are arranged in an overlapping manner such that at least portion of the forward flow path 122 serves as both the outlet of one segment and the inlet of an adjacent segment); the second outlet portion of one said Tesla valve unit is inclined at the same angle as the first inlet portion of the other said Tesla valve unit (annotated figure 1a, the second outlet portion is inclined at the same angle of the first inlet of the adjacent tesla valve unit).
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Regarding claim 9, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 5.
The combination further teaches characterized in that the outer sidewall has an auxiliary fixation structure (Sponsel [0014]; figure 1, fixation flanges 5) for preventing axial movement of said corneal path unidirectional aqueous humor drain.
Regarding claim 11, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 5.
The combination further teaches the drainage device comprises a biocompatible material (Sponsel; [0013] the device is made of surgical silicone or any of various other biocompatible polymers or gels).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sponsel et al (US 20220062044 A1) in view of Siebert (US 20220403838 A1), and in further view of Stergiopulos et al (US 20170348149 A1) and Forster et al (US 6227809 B1).
Regarding claim 6, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 5.
The combination does not teach characterized in that the length of the substrate is 1.0mm~6.0mm, and the thickness is 0.05mm~0.5mm ; the diameter of the inlet port and the diameter of the outlet part is 0.01 mm ~ 0.09 mm; though
In the same field of endeavor, namely an apparatus for treating excess intraocular fluid, Stergiopulos teaches the length of the substrate is 1.0mm~6.0mm, and the thickness is 0.05mm~0.5mm ([0025] the housing as dimensions of approximately 2 mm wide by 3 mm long by 0.5 mm high).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Siebert, to incorporate the teachings of Stergiopulos and provide the substrate as claimed for the purpose of providing adequate size for the corneal implant device as taught by Stergiopulos ([0024-0025]).
The combination is still silent as to the diameter of the inlet port and the diameter of the outlet part is 0.01 mm ~ 0.09 mm.
In the same field of endeavor, namely a micropump, Foster teaches the diameter of the inlet port and the diameter of the outlet port are 0.01mm~0.09mm (col 1 lines 62-67, the valve conduit sized from 10 to 100 um).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Sibert and Stergiopulos, to incorporate the teachings of Foster and provide the inlet and outlet ports as claimed, and one of skill in the art motivated to do so for the purpose of providing adequate size for the corneal implant device while achieving a desired drainage flow rate.
Regarding claim 7, Sponsel, as modified by Sibert, Stergiopulos and Forster, teaches the corneal path unidirectional aqueous humor drainage device according to claim 6.
The combination does not teach characterized in that the length of the substrate is 3.0mm~4.0mm, and the thickness is 0.15mm~0.3mm; the diameter of the liquid inlet and the liquid outlet is 0.02mm~0.06mm; though
The combination teaches the substrate is 2~3 mm long (Stergiopulos; [0025]), and the thickness is 0.5 mm (Stergiopulos; [0025]); the diameter of the liquid inlet and the diameter of the liquid outlet is 0.01mm~0.1mm (Foster; col 1 lines 62-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Sibert, Stergiopulos and Forster, and provides the substrate as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or close disclosed by the prior art’ a prima facie case of obviousness exists,” (MPEP 2144.05(I)). In the instant case, one of skill in the art motivated to do so, for the purpose of providing adequate size for the corneal implant device while achieving a desired drainage flow rate, and the applicant has not shown unexpected result gleaming from the claimed range (specification [0052-0053]), and therefore the claimed device is not patentably distinct from the prior art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sponsel et al (US 20220062044 A1) in view of Siebert (US 20220403838 A1), and in further view of Forster et al (US 6227809 B1).
Regarding claim 8, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 5.
The combination does not teach characterized in that the diameter of the drainage channel is 0.01mm~0.09mm.
In the same field of endeavor, namely a micropump, Foster teaches the diameter of the drainage channel is 0.01mm~0.09mm (col 1 lines 62-67, the valve conduit sized from 10 to 100 um).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Sibert, to incorporate the teachings of Foster and provide the drainage channel as claimed, and one of skill in the art motivated to do so for the purpose of providing adequate size for the corneal implant device while achieving a desired drainage flow rate, and it has been held that “[i]n the case where the claimed ranges ‘overlap or close disclosed by the prior art’ a prima facie case of obviousness exists,” (MPEP 2144.05(I)). In the instant case, one of skill in the art motivated to do so, for the purpose of providing a device of sufficient size for corneal implant device while achieving a desired drainage flow rate, and the applicant has not shown unexpected result gleaming from the claimed range (specification [0052-0053]), and therefore the claimed device is not patentably distinct from the prior art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sponsel et al (US 20220062044 A1) in view of Siebert (US 20220403838 A1), and in further view of Nigram (US 6142969 A).
Regarding claim 10, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 9.
The combination further teaches characterized in that said auxiliary fixation structure comprises: a plurality of radially projecting fixation portions on radial sides of said second side portion (Sponsel; figure 1, flanges 5 on distal tube 2); said plurality of fixation portions being arranged sequentially along said axial direction of said substrate (Sponsel; figure 1, flanges 5 being arranged sequentially along the longitudinal axis of distal tube 2).
The combination does not teach the length of said fixation portions disposed in said side portion of said substrate being greater than the length of said fixation portions disposed in said middle portion of said substrate , so that said substrate is arranged axially along said substrate, and the length of said fixed portions at said lateral portion of said substrate is greater than the length of said fixed portions at said central portion of said substrate, so that said substrate forms a barbed structure.
In the same field of endeavor, namely a Sutureless Implantable Device And Method For Treatment Of Glaucoma, Nigram teaches the length of said fixation portions disposed in said side portion of said substrate being greater than the length of said fixation portions disposed in said middle portion of said substrate (figures 8 and 10, W1 being greater than W3), so that said substrate is arranged axially along said substrate, and the length of said fixed portions at said lateral portion of said substrate is greater than the length of said fixed portions at said central portion of said substrate, so that said substrate forms a barbed structure.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Sibert, to incorporate the teachings of Nigram and provides the auxiliary fixation structure as claimed for the purpose of facilitating the device retaining between, and to be engaged by, adjacent recti muscles of eye, thereby prevent migration of the device without the need for suturing the device to the tissue of the eye as taught by Nigram (abstract and col 11 line 50 – col 12 line 47)
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sponsel et al (US 20220062044 A1) in view of Siebert (US 20220403838 A1), and in further view of Kotani (US 20180147776 A1).
Regarding claim 12, Sponsel, as modified by Sibert, teaches the corneal path unidirectional aqueous humor drainage device according to claim 11.
The combination does not teach characterized in that said biocompatible material is a light-curing biocompatible material.
Kotani teaches a photocured three-dimensional object, which relatively pertinent to the problem posed by applicant of providing material for medical device, characterized in that said biocompatible material is a light-curing biocompatible material ([0083] polyacrylic resin, polyacrylic resin is a (meth)acrylate-based monomer).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sponsel, as modified by Sibert, to incorporate the teachings of Kotani and provide the biocompatible material as claimed for the purpose of easily and quickly produce with high economical efficiency as taught by Kotani ([0046]).
Regarding claim 13, Sponsel, as modified by Sibert and Kotani, teaches the corneal path unidirectional aqueous humor drainage device according to claim 12.
The combination further teaches a photocured three-dimensional object, which relatively pertinent to the problem posed by applicant of providing material for medical device, comprising said light-curing biocompatible material comprises any one of an epoxy (meth)acrylate-based material, a polyester (meth)acrylate-based material, a polyurethane (meth)acrylate-based material, a (meth)acrylate-based monomer, and a (meth)acrylate-modified natural biomaterial (Kotani; [0083] polyacrylic resin).
Regarding claim 14, Sponsel, as modified by Sibert and Kotani, teaches the corneal path unidirectional aqueous humor drainage device according to claim 13.
The combination further teaches the light-curing biocompatible material includes any one of triethoxybisphenol A dimethacrylate, bisphenol A epoxy methacrylate, polyacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate-modified gelatin, and (meth)acrylate-modified hyaluronic acid (Kotani; [0083] polyacrylic resin).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Torello (US 20160242962 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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 at (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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/SETH HAN/Examiner, Art Unit 3781
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