DETAILED ACTION
Previously withdrawn claim 27 is canceled. Claims 19-26 and 28 remain withdrawn. Claims 1 and 13-16 are amended. A complete action on the merits of pending claims 1-7, 10-11, and 13-18 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 10/23/2025.
Claim Rejections - 35 USC § 103
Claim(s) 1-7, 10-11, and 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (WO 2015143308 A1 (See attached document)), in view of Chen (US Patent No. 9211608 B2), and further in view of Walter (US PGPUB No. 20130231605 A1).
Regarding claim 1, Peterson teaches, a vitrectomy probe (Figures 17-19, aspirating cutter (310); Paragraph [0053], lines 4-5, “The aspiration serves to draw vitreous material or other biological tissue into the ports (334, 346).” Indicating that the ophthalmic surgical cutting apparatus as disclosed is a vitrectomy probe, where “vitrectomy” is a surgery that involves the removal of the vitreous) comprising:
a hollow needle (Figures 13-14, outer tube (318); Paragraph [0050]) having a sidewall (Figures 13-14, annular side wall (320); Paragraph [0051]) and a tip (Figures 13-14, tip (326); Paragraph [0051]);
a port (Figures 13-14, first port (334); Paragraph [0051]) formed in the sidewall (annular side wall (320)) of the hollow needle (outer tube (318)) and spaced apart from the tip (tip (326)) (Figures 13-14); and
a cutter (Figures 15-19, inner tube (322); Paragraph [0050]) positioned within the hollow needle (outer tube (318)) (Figures 17-19), the cutter (inner tube (322)) being slidable relative to the port (first port (334)) to cut tissue within the port (first port (334)) (Paragraph [0053]).
Peterson fails to teach, the tip being formed by a separate piece of material secured to an end of the hollow needle to close the end; and a manipulation feature defined by at least one recess spaced apart and separate from the port, the at least one recess formed in at least the tip of the hollow needle by a wire electrical discharge machining (EDM) process or a laser cutting process, the manipulation feature configured to facilitate manipulation of tissue using the hollow needle; wherein the manipulation feature includes one or more selected from the group consisting of a pick or a hook.
Chen discloses, a guillotine-style ophthalmic cutting device that includes a handle, a hollow needle, a welded end cap, a port, and a hollow cutter. Chen teaches, the tip (Figures 2-4, end cap (48)) being formed by a separate piece of material (Col. 3, line 47-51) secured to an end (Figures 2-3, second end (28)) of the hollow needle (Figures 2-4 and 6, circular cylindrical hollow needle (24)) to close the end (Col. 2, line 53-59, discloses, “The second end (28) of the needle (24) includes an end surface (46). An end cap (48) is fused to the end surface (46) by a weld (52) to enclose the needle (24). The end cap (48) is a circular disc that includes a substantially flat inner surface (54), a substantially flat outer surface (56), and a circumferential surface (58) disposed between the inner surface (54) and the outer surface (56).”).
Walter discloses, aspiration tips that are suitable for use in ophthalmic surgery. Walter teaches, a manipulation feature (Figures 1-3, textured surface (10t); Paragraph [0063]) defined by at least one recess (Figure 10E, where the textured surface (10t) forms/includes dimples/recessions (10d) as disclosed in paragraph [0079]; Examiner notes that paragraph [0079] includes errors, and that this office action considered those errors when referring to paragraph [0079] and Figures 10A-10E) spaced apart and separate from the port (Figures 1 and 3, aspiration port (30); Paragraph [0068]; As clearly seen in Figures 1-3, the dimples/recessions (10d) are indeed separate and spaced apart from the port), the at least one recess (dimples/recessions (10d)) formed in at least the tip (Figures 1-3, tip (10)) of the hollow needle (Figure 1, surgical device (20)), the manipulation feature (textured surface (10t)) configured to facilitate manipulation of tissue using the hollow needle (The abstract discloses, “Devices and methods for cataract surgery include a tip with a textured outer surface that is configured to gently scrape the capsule bag to allow aspiration of cortical tissue.” Where “gently scrape” is a clear indication of facilitating manipulation of tissue); wherein the manipulation feature (textured surface (10t)) includes one or more selected from the group consisting of a pick or a hook (Paragraph [0079] discloses that dimples/recessions may be formed as the textured surface, while paragraph [0083], discloses a method of forming such dimples, may include sandblasting. As such, this structure is considered an obvious variation of the recesses/textured surface taught by Walter, as adjusting common manufacturing parameters such as sandblasting pressure, material, and angle to create sharper, asymmetric edges is a well-known technique in the art to enhance engagement/scraping functionality, achieving a predictable result).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the tip is substituted for that of Chen, where the tip is formed by a separate piece of material secured to an end of the hollow needle to close the end, which is then modified to include a manipulation feature defined by at least one recess spaced apart and separate from the port, the at least one recess formed in the tip of the hollow needle, the manipulation feature configured to facilitate manipulation of tissue using the hollow needle as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the tip is substituted for that of Chen, where the tip is formed by a separate piece of material secured to an end of the hollow needle to close the end, which is then modified to include a manipulation feature defined by at least one recess spaced apart and separate from the port, the at least one recess formed in the tip of the hollow needle, the manipulation feature configured to facilitate manipulation of tissue using the hollow needle as taught by Walter, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement. Further, the limitation, “the at least one recess formed in at least the tip of the hollow needle by a wire electrical discharge machining (EDM) process or a laser cutting process,” may be considered a process limitation that renders at least claim 1 to be a product-by-process claim, where the claim is not limited to the manipulation of the recited step. The claim is limited only to the structure implied by the step, Peterson in view of Chen and further in view of Walter indeed disclose the structure implied by step of, “the at least one recess formed in at least the tip of the hollow needle by a wire electrical discharging machining (EDM) process or a laser cutting process,” including the structure of a "pick" or "hook" achieved via alternative, obvious manufacturing adjustments (e.g., sandblasting parameters). Walter already suggests multiple alternative methods in paragraph [0083] for forming the textured surface, e.g., sandblasting, pinging, molding, or rubbing against a rough tool or sand paper, etc., that produce the same structural result of forming “at least one recess” with the obvious design variations of a "pick" or "hook" shape.
Regarding claim 2, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the at least one recess is an arcuate recess having a curved base.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the at least one recess (dimples/recessions (10d)) is an arcuate recess having a curved base (The term “dimple” generally refers to small, shallow depressions with a curved base, thus the dimples/recessions (10d) are indeed arcuate and have a curved base).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the at least one recess is an arcuate recess having a curved base as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the at least one recess is an arcuate recess having a curved base as taught by Walter, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
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Regarding claim 3, Peterson teaches, the port (first port (334)) has a first radius of curvature (See annotated Figure 14 above, (First radius of curvature)).
Peterson fails to teach, the arcuate recess has a second radius of curvature, and wherein the first and second radii of curvature are located in a same plane.
Chen teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the arcuate recess (dimples/recessions (10d)) has a second radius of curvature (Paragraph [0079], describe the textured surface (10t) as having dimples/recession (10d) which are shown in Figure 10E, as such a radius of curvature is taken from the opening of dimple/recession (10d) to the curved base of the arcuate recess).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the arcuate recess has a second radius of curvature as taught by Walter, which results in the first and second radii of curvature being located in a same plane, seeing as how, Figures 1 and 3 of Walter, show the textured surface on the dome-shaped/semi-circular tip, thus a radius of a dimple/recession along the sides of the tip rather than the very top will result in the radii of curvature being located in a same plane in light of how the radius of curvature of the port (334) taught by Peterson is taken as seen in the Figure above, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the arcuate recess has a second radius of curvature as taught by Walter, which results in the first and second radii of curvature being located in a same plane, seeing as how, Figures 1 and 3 of Walter, show the textured surface on the dome-shaped/semi-circular tip, thus a radius of a dimple/recession along the sides of the tip rather than the very top will result in the radii of curvature being located in a same plane in light of how the radius of curvature of the port (334) taught by Peterson is taken as seen in the Figure above, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
Regarding claim 4, Peterson teaches, the port (first port (334)) has a first radius of curvature (See annotated Figure 14 above, (First radius of curvature)).
Peterson fails to teach, the arcuate recess has a second radius of curvature, and wherein the first and second radii of curvature are located in different planes.
Chen teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the arcuate recess (dimples/recessions (10d)) has a second radius of curvature (Paragraph [0079], describe the textured surface (10t) as having dimples/recession (10d) which are shown in Figure 10E, as such a radius of curvature is taken from the opening of dimple/recession (10d) to the curved base of the arcuate recess).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the arcuate recess has a second radius of curvature as taught by Walter, which results in the first and second radii of curvature being located in different planes, seeing as how, Figures 1 and 3 of Walter, show the textured surface on the dome-shaped/semi-circular tip, thus a radius of a dimple/recession along the top of the tip rather than the sides will result in the radii of curvature being located in different planes in light of how the radius of curvature of the port (334) taught by Peterson is taken as seen in the Figure above, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the arcuate recess has a second radius of curvature as taught by Walter, which results in the first and second radii of curvature being located in different planes, seeing as how, Figures 1 and 3 of Walter, show the textured surface on the dome-shaped/semi-circular tip, thus a radius of a dimple/recession along the top of the tip rather than the sides will result in the radii of curvature being located in different planes in light of how the radius of curvature of the port (334) taught by Peterson is taken as seen in the Figure above, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
Regarding claim 5, Peterson in view of Chen and further in view of Walter teach the claimed invention except for, “wherein the arcuate recess has a radius of curvature that is 3 mils or less.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the arcuate recess have a radius of curvature that is 3 mils or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller.
Regarding claim 6, Peterson teaches, the hollow needle (outer tube (318)).
Peterson fails to teach, wherein the separate piece of material secured to the end of the hollow needle includes a weld bead, and wherein the at least one recess is formed in the weld bead.
Chen teaches, the separate piece of material (end cap (48); Col. 3, line 47-51) secured to the end (second end (28)) of the hollow needle (circular cylindrical hollow needle (24)) includes a weld bead (Col. 2, line 54-55, discloses, “An end cap (48) is fused to the end surface (46) by a weld (52) to enclose the needle (24).” Further, Col. 4, line 13-17, describe the use of “laser welding”, thus a weld bead must inherently be present as it is a natural byproduct of the process).
Walter teaches, the at least one recess (dimples/recessions (10d)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the separate piece of material secured to the end of the hollow needle includes a weld bead as taught by Chen, which is further modified to have the at least one recess as taught by Walter formed in the weld bead taught by Chen, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the separate piece of material secured to the end of the hollow needle includes a weld bead as taught by Chen, which is further modified to have the at least one recess as taught by Walter formed in the weld bead taught by Chen, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
Regarding claim 7, Peterson teaches, the hollow needle (outer tube (318)).
Peterson fails to teach, wherein the separate piece of material secured to the end of the hollow needle includes an end cap that is separate from and secured to the sidewall.
Chen teaches, the separate piece of material (end cap (48); Col. 3, line 47-51) secured to the end (second end (28)) of the hollow needle (circular cylindrical hollow needle (24)) includes an end cap that is separate from and secured to the sidewall (Figure 3, inner surface (32), outer surface (38), and wall thickness (34) define the sidewall of hollow needle (24) as disclosed in Col. 2, lines 40-61, this also indicates that end surface (46) of needle (24) seen in Figure 3 is part of the sidewall, and further the end cap (48) is disclosed as being separate and then welded/secured to the end surface (46) of the sidewall of the needle (24) as disclosed in Col. 2, line 53-59 and Col. 3, line 47-56).
Walter teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the separate piece of material secured to the end of the hollow needle includes an end cap that is separate from and secured to the sidewall as taught by Chen, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the separate piece of material secured to the end of the hollow needle includes an end cap that is separate from and secured to the sidewall as taught by Chen, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
Regarding claim 10, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the at least one recess is an annular recess formed around an entire circumference of the tip.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the at least one recess (dimples/recessions (10d)) is an annular recess formed around an entire circumference of the tip (Figures 1-3; Paragraph [0079], discloses in part, that the textured surface (10t) can be formed as dimples/recession (10d) as seen in Figure 10E, while in paragraph [0073], it is disclosed, “As shown in FIGS. 1-3, the textured surface (10t) can cover only the distal end of the tip (10) and typically terminates prior to the aspiration port(s) (30)…” Thus, in light of Figures 1-3 and these disclosures, the textured surface (dimples) inherently disclose a recessed patter, which are arranged/formed around an entire circumference of the tip, forming an annular recess).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the at least one recess is an annular recess formed around an entire circumference of the tip as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the at least one recess is an annular recess formed around an entire circumference of the tip as taught by Walter, as such a modification would have been predictable, namely, to allow for consistent tissue interaction.
Regarding claim 11, Peterson further teaches, wherein the cutter (inner tube (322)) includes a first cutting edge (Figures 15-16, undercut lip (350); Paragraphs [0052]-[0053]) and a second cutting edge (Figures 15-16, undercut lip (342); Paragraphs [0052]-[0053]) spaced apart from the first cutting edge (Figures 15-16), wherein the first cutting edge (undercut lip (350)) is configured to cut tissue as the cutter moves past the port (first port (334)) in a first direction (Figures 17-19; Paragraph [0053]), and wherein the second cutting edge (undercut lip (342)) is configured to cut tissue as the cutter (inner tube (322)) moves past the port (first port (334)) in a second direction that is opposite the first direction (Paragraph [0053]).
Regarding claim 13, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the manipulation feature includes the pick, and wherein the pick is defined at an intersection of the tip of the hollow needle and the sidewall of the hollow needle by one or more recesses in the tip of the hollow needle.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the manipulation feature (textured surface (10t)) includes the pick, and wherein the pick is defined at an intersection of the tip (tip (10)) of the hollow needle and the sidewall of the hollow needle by one or more recesses (dimples/recessions (10d)) in the tip of the hollow needle (In paragraph [0079] it is disclosed that dimples/recessions may be formed as the textured surface, while paragraph [0083], discloses a method of forming such dimples, may include sandblasting. As discussed in the rejection of claim 1, sandblasting parameters such as pressure, material, and duration are capable of being adjusted such that they create recesses with sharper or more defined edges and a sharper sandblasted recess inherently functions as a pick. Further, this does exist at an intersection of the tip (10) and sidewall of the surgical device (20), seeing as how end cap (26) of tip (10), as seen in Figures 1 and 3 and disclosed in paragraph [0070], is placed over surgical device (20) and includes the textured surface (10t), thus there is indeed an intersection between the tip and the sidewall of the hollow needle, which is where the pick is located (as the pick is simply an obvious variation of the dimple/recess feature in that precise location)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the manipulation feature includes the pick, and wherein the pick is defined at an intersection of the tip of the hollow needle and the sidewall of the hollow needle by one or more recesses in the tip of the hollow needle as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the manipulation feature includes the pick, and wherein the pick is defined at an intersection of the tip of the hollow needle and the sidewall of the hollow needle by one or more recesses in the tip of the hollow needle as taught by Walter, as such a modification would have been predictable, namely, to improve engagement with tissue at a specific, functional location on the device.
Regarding claim 14, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the manipulation feature includes the hook, and wherein the hook is defined by a recess in the sidewall of the hollow needle.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the manipulation feature (textured surface (10t)) includes the hook, and wherein the hook is defined by a recess (In paragraph [0079] it is disclosed that dimples/recessions may be formed as the textured surface, while paragraph [0083], discloses a method of forming such dimples, may include sandblasting. As discussed in the rejection of claim 1, sandblasting is capable of producing asymmetric recesses when applied at an angle or with varied intensity, where creating asymmetric, undercut, or curved recesses inherently results in a hook-like feature); and wherein the hook is defined by a recess in the sidewall of the hollow needle (the placement of the hook feature in the sidewall is a predictable design choice for a POSITA, motivated by the desire to engage tissue from the side or to improve manipulation functionality in different surgical orientations, consistent with the general purpose of the prior art).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the manipulation feature includes the hook, and wherein the hook is defined by a recess through the method of sandblasting as taught by Walter, which would then also be applied to a sidewall of the hollow needle, given that a sandblasted recess merely requires increasing the depth on one side, creating an overhang or making it asymmetrical to form a hook-like structure, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the manipulation feature includes the hook, and wherein the hook is defined by a recess through the method of sandblasting as taught by Walter, which would then also be applied to a sidewall of the hollow needle, given that a sandblasted recess merely requires increasing the depth on one side, creating an overhang or making it asymmetrical to form a hook-like structure, as such a modification would have been predictable, namely, to improve engagement with tissue.
Regarding claim 15, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the manipulation feature also includes a scraper defined in the tip of the hollow needle by the at least one recess encompassing an intersection of the tip of the hollow needle and the sidewall of the hollow needle.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the manipulation feature (textured surface (10t)) also includes a scraper defined in the tip (tip (10)) of the hollow needle (surgical device (20)) by the at least one recess (dimples/recessions (10d)) encompassing an intersection of the tip of the hollow needle and the sidewall of the hollow needle (In paragraph [0079] it is disclosed that dimples/recessions may be formed as the textured surface, while paragraph [0083], discloses a method of forming such dimples, may include sandblasting. A “scraper” is typically a structure with an edge or sharp surface designed to slide against tissue to remove or manipulate it. Sandblasting typically creates textured recesses on a surface, which includes sharp or angled recess edges, that function as scrapers, which aligns with the disclosure of the abstract, which discloses that a use of the textured surface is to scrape tissue. Further, this does encompass an intersection of the tip (10) and sidewall of the surgical device (20), seeing as how end cap (26) of tip (10), as seen in Figures 1 and 3 and disclosed in paragraph [0070], is placed over surgical device (20) and includes the textured surface (10t), thus there is indeed an intersection between the tip and the sidewall of the hollow needle; the applicant's amendment merely confirms a function and location that is already explicitly taught and suggested by the combination of prior art references).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the manipulation feature also includes a scraper defined in the tip of the hollow needle by the at least one recess encompassing an intersection of the tip of the hollow needle and the sidewall of the hollow needle as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the manipulation feature also includes a scraper defined in the tip of the hollow needle by the at least one recess encompassing an intersection of the tip of the hollow needle and the sidewall of the hollow needle as taught by Walter, as such a modification would have been predictable, namely, to improve the tissue scraping function of the tool.
Regarding claim 16, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the manipulation feature also includes a corrugated surface defined by a plurality of recesses in the tip of the hollow needle.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, the manipulation feature (textured surface (10t)) also includes a corrugated surface defined by a plurality of recesses in the tip of the hollow needle (Paragraph [0079], discloses in part, “Combinations of projections and recessions, e.g., mounds and dimples, can also be used.” This corresponds to a corrugated surface defines by a plurality of recesses in the tip (10); the term "corrugated surface" is considered a synonym or obvious descriptive term for the "combinations of projections and recessions" disclosed by Walter).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the manipulation feature also includes a corrugated surface defined by a plurality of recesses in the tip of the hollow needle as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the manipulation feature also includes a corrugated surface defined by a plurality of recesses in the tip of the hollow needle as taught by Walter, as such a modification would have been predictable, namely, to improve engagement with tissue by providing surface irregularities.
Regarding claim 17, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Peterson fails to teach, wherein the manipulation feature is a first manipulation feature and the at least one recess is a first recess, and further comprising a second manipulation feature spaced apart from the first manipulation feature and defined by a second recess formed in the tip of the hollow needle.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1).
Walter teaches, wherein the manipulation feature (textured surface (10t)) is a first manipulation feature and the at least one recess (dimples/recessions (10d)) is a first recess, and further comprising a second manipulation feature spaced apart from the first manipulation feature and defined by a second recess formed in the tip of the hollow needle (As seen in Figure 10E and disclosed in paragraph [0079], the textured surface (10t) defines a plurality of dimples/recessions (10d) which would allow for a second manipulation feature spaced apart from the first manipulation feature and defined by a second recess formed in the tip of the hollow needle as seen in Figures 1-3 and disclosed in paragraph [0073]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the manipulation feature is a first manipulation feature and the at least one recess is a first recess, and further comprising a second manipulation feature spaced apart from the first manipulation feature and defined by a second recess formed in the tip of the hollow needle as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the manipulation feature is a first manipulation feature and the at least one recess is a first recess, and further comprising a second manipulation feature spaced apart from the first manipulation feature and defined by a second recess formed in the tip of the hollow needle as taught by Walter, as such a modification would have been predictable, namely, to enhance and aid in tissue engagement.
Regarding claim 18, Peterson teaches, aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1), which claim 17 that claim 18 depends from depends upon.
Peterson fails to teach, wherein the second manipulation feature is different than the first manipulation feature.
Chen teaches, other aspects of the vitrectomy probe according to claim 1 (See above rejection of claim 1), which claim 17 that claim 18 depends from depends upon.
Walter teaches, the second manipulation feature is different than the first manipulation feature (Paragraph [0083], discloses, “The textured surface (10t) of the tip can be formed or provided in any suitable manner. For example, coating the sleeve using a biocompatible coating, such as a coating with particulates, dipping the sleeve in an acid rinse or ultrasonic bath (for pitting), embossing the sleeve, or molding the sleeve in a mold which provides the desired surface texture or attaching a small separate patch material onto a portion of the outer surface of the tip. In some embodiments, the textured surface of the sleeve (24) can be rough but without jagged edges that might tear the capsule bag. The roughened textured surface (10t) may be formed in any suitable manner such as sandblasting, pinging, rubbing against a rough tool or sand paper and the like.” Thus, a process of formation such as sandblasting would create distinct dimples/recessions (10d) of textured surface (10t)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Peterson such that the second manipulation feature is different than the first manipulation feature as taught by Walter, as all the references and the claimed invention are directed to ophthalmic surgery devices and their tips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson such that the second manipulation feature is different than the first manipulation feature as taught by Walter, as such a modification would have been predictable, namely, improve engagement with tissue by providing surface irregularities.
Response to Arguments
Applicant's arguments filed on 10/23/2025 have been fully considered but they are not persuasive.
Arguments Regarding Independent Claim 1 (Product-by-Process Limitations):
The Applicant argues that the combined prior art does not disclose a "pick" or a "hook," nor the use of Wire Electrical Discharge Machining (EDM) or laser cutting processes to create these features in the material disclosed by Walter.
Regarding the "Pick" or "Hook" Structure:
The Examiner maintains that the "pick" or "hook" limitation is an obvious variation of the "textured surface" with "dimples/recessions" taught by Walter. The Applicant correctly notes that the Examiner did not find an explicit written description of a "pick" or "hook" in the prior art references. However, the Examiner established a prima facie case of obviousness based on predictable design choices available to a Person of Ordinary Skill in the Art (POSITA).
The Applicant's reliance on In re Rijckaert and MPEP 2112(IV) regarding inherency is noted. The Examiner's position is not strictly one of pure inherency (that a pick/hook necessarily occurs every time one sandblasts), but rather an argument of obvious design choice and predictable result under KSR v. Teleflex. The prior art combination provides the motivation (enhance tissue engagement) and the means (sandblasting method, general location of features). A POSITA, motivated to enhance scraping, would have found it obvious to adjust known parameters (angle, pressure) to create the slightly sharper edges that inherently function as a pick or a hook. This is a predictable result of applying known engineering principles to the prior art's method. The Examiner officially notices that the adjustment of common manufacturing parameters such as sandblasting pressure, material, and angle to create sharper, asymmetric edges to enhance engagement is a well-known technique in the art, which falls outside the definition of "pure inherency" challenge. The Applicant has failed to provide any factual evidence (e.g., test data or a declaration) to show that this modification produces an unexpected or non-predictable result.
Regarding the "Wire EDM/Laser Cutting Process" Limitation:
The Applicant argues that it would not have been obvious to apply EDM or laser cutting to Walter's elastomeric/polymeric end cap because these materials are non-conductive or cannot withstand the heat.
The Examiner acknowledges that the claims are product-by-process claims, limited by the structure implied by the process steps. However, the claims themselves do not recite a material limitation (e.g., "a conductive material" or "a heat-resistant material"). The broadest reasonable interpretation of the claim language does not exclude the use of materials suitable for EDM or laser cutting processes that would still result in the claimed structure. It would have been obvious for a POSITA to select a suitable, alternative material (e.g., a metal alloy suitable for the claimed process and medical use, which is common in vitrectomy probes as seen in Peterson) that allows the application of the claimed manufacturing method to achieve the desired structure. The Applicant's argument improperly imports material limitations not present in the claims and focuses on why one specific material in the prior art would not work, rather than why the claimed invention as a whole is non-obvious.
Conclusion on Claim 1:
The Examiner maintains that the claimed "pick or hook" structure is an obvious variant of Walter's textured surface, and the manufacturing process limitations do not render the claim non-obvious because suitable materials were available in the art. Therefore, independent claim 1 remains unpatentable.
Regarding Claims 13-16 (Amended dependent Claims):
Claims 13-16 are dependent on claim 1. As independent claim 1 is rejected, the dependent claims necessarily fall. Furthermore, the specific limitations added to claims 13-16 (specific location of a pick, hook in the sidewall, scraper, corrugated surface) are also considered obvious design choices for a POSITA optimizing a surgical device for better tissue engagement, as detailed in the previous office action and reiterated in the rejection sections above.
See updated rejection above.
Conclusion
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771