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 .
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.
Claim 15 is 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.
In claim 15, line 4, the expression “may be” renders the claim indefinite because it is not clear if the device is, or is not, opened and closed via a hinge.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Benham (U.S. Patent No. 4,554,849 A).
Regarding claim 1, Benham (see the entire document, in particular, col. 1, lines 8-13; col. 2, lines 39-45; col. 3, lines 46-60; col. 4, lines 52-62; col. 4, line 68 to col. 5, line 2; col. 5, lines 23-31; Figures 1, 6, 7 and 11-14) teaches an apparatus (see col. 1, lines 8-13 (apparatus for producing holes in the walls of tubes for medical devices) of Benham), including (a) a main body extending along a longitudinal axis between a first surface at a first end of a device and a second surface at a second end of a device (see Figures 1 and 11; col. 2, lines 39-45 (guide and punch mounting block 20 (i.e., main body)) of Benham); (b) an outer surface extending from a first edge at the first surface to a second edge at the second surface (see Figures 1 and 11; col. 2, lines 39-45 (outer surface of guide and punch mounting block 20 (i.e., main body)) of Benham); (c) a central lumen defined by the main body along the longitudinal axis, the central lumen extending from a first opening at the first surface to a second opening at a second surface (see Figures 1 and 11; col. 2, lines 39-45 (central passage or guideway 22 (i.e., central lumen)) of Benham); and (d) a plurality of side lumens defined by a plurality of side openings in the outer surface and extending from the plurality of side openings, through the main body, and into the central lumen (see Figures 6, 7 and 11; col. 3, lines 46-60 (openings or bores 124 (i.e., side lumens)) of Benham), (d)(1) wherein the device is configured for accepting a tube in the central lumen (see Figure 11; col. 4, lines 52-62 (catheter tubing stock 174 and polymer rod 170 are placed in central passage or guideway 22 (i.e., central lumens)) of Benham), and (d)(2) wherein the device is further configured for accepting a needle or suturing device in the plurality of side lumens (see Figures 11-13; col. 4, line 68 to col. 5, line 2 (punches 150 enter passages 124 (i.e., side lumens)) of Benham). Regarding the recitation of an ocular implant, the instant claims are apparatus claims, and the material or article worked upon by an apparatus does not limit apparatus claims (see MPEP §2115).
Regarding claims 2 and 3, see Figure 14; col. 5, lines 23-31 (punched section 182) of Benham.
Regarding claims 4-6, 8 and 9, see Figures 6, 7 and 11; col. 3, lines 55-60 (bores 124 are shown on both sides of guide and punch mounting block 20; bores 124 are formed in a desired pattern with generally uniform spaces; bores 124 have a consistent diameter/size (i.e., no disclosure of different diameters/sizes); see MPEP §2115) of Benham.
Regarding claim 7, see Figures 11-13; col. 4, line 68 to col. 5, line 2 (punches 150 enter passages 124 (i.e., side lumens)) of Benham.
Regarding claim 10, see Figures 7 and 11; col. 3, lines 55-60 (bores 124 are formed in a desired pattern) of Benham.
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.
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benham (U.S. Patent No. 4,554,849 A) as applied to claims 1-10 above, and further in view of Forsryd et al (U.S. Patent Application No. 2022/0265960 A1) and Peyman (U.S. Patent No. 10,278,920 B1).
Regarding claim 11, Benham does not teach (1) a tube inner diameter of about 0.32 mm, (2) a tube outer diameter of about 0.64 mm, or (3) a tube length of about 32 mm. Forsryd et al (see the entire document, in particular, paragraphs [0002], [0018] and [0031]; Figure 2a) teaches an apparatus (see paragraph [0018] (machine for manufacturing openings in tubing) of Forsryd et al), including a tube outer diameter about 0.64 mm (see Figure 2a, paragraph [0031] (outer diameter of the cross-section of tubing 8 is 0.1-10 mm, and may vary depending on the application (this includes an inner diameter)) of Forsryd et al), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a tube inner diameter and a tube outer diameter in the apparatus of Benham in view of Forsryd et al in order to provide a device which does not have sharp edges or protrusions (see paragraph [0002] of Forsryd et al; see also MPEP §2115). Peyman (see the entire document, in particular, col. 2, lines 5-10; col. 57, lines 28-29, 44-46 and 48-54) teaches a device (see col. 2, lines 5-10 (a drug delivery implant) and col. 57, lines 28-29 (implant can act as a shunt for glaucoma) of Peyman), including a tube length of about 32 mm (see col. 57, lines 44-46 (implant is 1-60 mm long) of Peyman), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claims invention to provide a tube having a length of about 32 mm in the apparatus of Benham in view of Peyman in order to cover an entire corneal periphery without pressing corneal tissue in any direction (see col. 57, lines 44-46 of Peyman; see also MPEP §2115).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benham (U.S. Patent No. 4,554,849 A) as applied to claims 1-10 above, and further in view of Peyman (U.S. Patent No. 10,278,920 B1).
Regarding claim 12, Benham does not teach (1) a diameter of the side openings is about 0.1 mm or based on a 7-0 suture needle diameter. Peyman (see the entire document, in particular, col. 2, lines 5-10; col. 57, lines 28-29, 44-46 and 48-54) teaches a device (see col. 2, lines 5-10 (a drug delivery implant) and col. 57, lines 28-29 (implant can act as a shunt for glaucoma) of Peyman), including a diameter of side openings of about 0.1 mm (see col. 57, lines 48-51 (holes in tube wall have a diameter of 5-500 microns (0.005-0.5 mm) of Peyman), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a diameter of side openings of about 0.1 mm in the apparatus of Benham in view of Peyman in order to provide holes in a tube wall of a desired diameter to permit diffusion of material (see col. 57, lines 51-54 of Peyman).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benham (U.S. Patent No. 4,554,849 A) as applied to claims 1-10 above, and further in view of Rawlings (U.S. Patent No. 4,259,276 A).
Regarding claim 14, Benham does not teach (1) an occluded tube. Rawlings (see the entire document, in particular, col. 1, line 67 to col. 2, line 2; col. 2, lines 15-16 and 23-29; Figures 1 and 2) teaches an apparatus (see Figure 2; col. 2, lines 15-16 (tooling for manufacturing a medical device having holes) of Rawlings), including an occluded tube (see Figure 1; col. 2, lines 23-29 (distal end 4 is occluded) of Rawlings), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide an occluded tube in the apparatus of Benham in view of Rawlings in order to provide hole formation in a medical device (see col. 1, line 67 to col. 2, line 2 of Rawlings; see also MPEP §2115).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benham (U.S. Patent No. 4,554,849 A) in combination with Odrich (U.S. Patent Application Publication 2002/0193725 A1).
Regarding claim 16, Benham (see the entire document, in particular, col. 1, lines 8-13; col. 2, lines 39-45; col. 3, lines 46-60; col. 4, lines 52-62; col. 4, line 68 to col. 5, line 2; col. 5, lines 23-31; Figures 1, 6, 7 and 11-14) teaches a process (see col. 1, lines 8-13 (method for producing holes in the walls of tubes of medical devices) of Benham), including (a) providing a fenestration template device having a central lumen defined by a main body and a plurality of side lumens extending from an outer surface of the main body to the central lumen (see Figures 1, 6, 7 and 11; col. 2, lines 39-45 (guide and punch mounting block 20 (i.e., main body); outer surface of guide and punch mounting block 20 (i.e., main body); central passage or guideway 22 (i.e., central lumen) and col. 3, lines 46-60 (openings or bores 124 (i.e., side lumens)) of Benham); (b) providing a medical device having a tube (see Figure 11; col. 4, lines 52-62 (catheter tubing stock 174 and polymer rod 170 are placed in central passage or guideway 22 (i.e., central lumen)) of Benham); (c) inserting the tube into the central lumen of the fenestration template device (see Figure 11; col. 4, lines 52-62 (catheter tubing stock 174 and polymer rod 170 are placed in central passage or guideway 22 (i.e., central lumen)) of Benham); (e) inserting a needle or suturing device into at least one of the side lumens (see Figures 11-13; col. 4, line 68 to col. 5, line 2 (punches 150 enter passages 124 (i.e., side lumens)) of Benham); and (f) producing, by the needle or suturing device, at least one fenestration in the tube (see Figure 14; col. 5, lines 23-31 (punched section 182) of Benham), (f)(1) wherein the at least one fenestration is configured for a flow rate of material (see col. 3, lines 55-60 (bores 124 are formed in a desired pattern for holes to be produced with generally uniform spacing) of Benham). Benham does not teach (1) an ocular implant as a medical device, or (2) ligating a proximal end of a tube. Odrich (see the entire document, in particular, paragraphs [0014], [0039] and [0041]; Figure 4) teaches a device (see Figure 4, paragraphs [0014] (provide a glaucoma shunt (i.e., an ocular implant)) and [0039] (device 10 includes one or more fenestrations or holes through the wall of shaft 30) of Odrich), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medical device of Odrich (i.e., an ocular implant) for the medical device of Benham (i.e., a catheter) because the substitution of one known element for another known element would have yielded predictable results (e.g., the manufacture of a medical device having holes in the walls) to one of ordinary skill in the art. Regarding (2), Odrich teaches ligating a proximal end of a tube (see Figure 4, paragraph [0041] (device 10 includes a ligature suture 95) of Odrich), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ligate a proximal end of a tube in the process of Benham in view of Odrich in order to constrict (e.g., control) flow of aqueous humor (see paragraph [0041] of Odrich).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benham (U.S. Patent No. 4,554,849 A) in combination with Odrich (U.S. Patent Application Publication 2002/0193725 A1) as applied to claims 16-19 above, and further in view of Nissan et al (U.S. Patent Application Publication 2013/0150773 A1).
Regarding claim 20, Benham (in combination with Odrich) does not teach (1) threading s suture through at least on fenestration in a tube. Nissan et al (see the entire document, in particular, paragraphs [0018] and [0024]; Figures 2 and 9) teaches a process (see Figure 9, paragraph [0018] (method for using a glaucoma shunt) of Nissan et al), including threading s suture through at least on fenestration in a tube (see Figure 2, paragraph [0024] (tube 201 may be coupled through suture holes 205a, 205b) of Nissan et al), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to thread a suture through at least one fenestration in a tube in the process of Benham (in combination with Odrich) in view of Nissan et al in order to couple a tube to a portion of an eye (see paragraph [0024] of Nissan et al).
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEO B. TENTONI whose telephone number is (571)272-1209. The examiner can normally be reached 7:30-4:00 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina A. Johnson can be reached at (571)272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LEO B. TENTONI
Primary Examiner
Art Unit 1742
/LEO B TENTONI/Primary Examiner, Art Unit 1742
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