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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 5-17 of U.S. Patent No. 11,937,954. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding claims 1 and 34 the patent recites a combination Femto laser (Femto) and Phacoemulsification (Phaco) surgical device, comprising:
a. a housing having a plurality of articulating segments, wherein each of the segments is movable with respect to the housing; b. wherein a first segment of the plurality of articulating segments is coupled to a Femto device via an articulating arm; c. wherein a second segment of the plurality of articulating segments is coupled to a tray configured to hold a set of hand pieces for use in phacoemulsification; d. wherein a third segment of the plurality of articulating segments is coupled with a keyboard tray (claim 20); e. a display disposed on a portion of the housing (claim 1); and f. wherein the first segment and the second segment are independently movable about the housing (claim 1); and f. wherein the Femto device and tray can move and articulate with respect to one other, such that movement of a patient is not required between the Femto and Phaco procedures (claim 4).
Regarding the dependent claims, the following table compares the dependent claims of the present application (US 18/615,658) with the claims of the Patent (US 11,937,954).
Dependent claims of the Present Application (US 18/615,658)
Dependent claims of Patent (US 11,937,954)
19. The device of claim 18, wherein the housing comprises Femto and Phaco surgical systems and interfaces and a controller for controlling the Femto and Phaco surgical systems.
2. The device of claim 1, wherein the Femto surgical device and the Phaco surgical system interface with a controller for controlling the Femto surgical device and Phaco surgical system.
20. The device of claim 18, comprising a controller; wherein the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient.
3. The device of claim 1, wherein the controller permits a user to utilize both the Femto surgical device and Phaco surgical system without moving a patient.
21. The device of claim 18, wherein the Femto device comprises a Femto laser head configured to move in a vertical X movement and horizontal Y movement or any angle to place the Femto laser head at a patient's eye or be removed from the patient's eye during surgery.
5. The device of claim 1, wherein the Femto laser head is configured to move in a vertical X movement and horizontal Y movement or any angle to place the Femto laser head at a patient's eye or be removed from the patient's eye during surgery.
22. The device of claim 21, wherein the keyboard or keyboard tray is configured to move in a vertical X movement and horizontal Y movement or any angle with or independently from the Femto laser head.
6. The device of claim 5, wherein the keyboard or keyboard tray is configured to move in a vertical X movement and horizontal Y movement or any angle with or independently from the Femto laser head.
23. The device of claim 18, wherein the tray is configured to hold a Phaco hand piece, a VIT hand piece, an irrigation hand piece and an aspiration hand piece.
7. The device of claim 1, wherein the tray is configured to hold a Phaco hand piece, a vitrectomy (VIT) hand piece, an irrigation hand piece and an aspiration hand piece.
24. The device of claim 18, wherein the tray is configured to articulate along X and Y axes or at any angle, such that the tray can be placed into the surgical field at or about a patient's eye height for a Phaco surgical procedure without requiring movement of the patient.
8. The device of claim 1, wherein the tray is configured to articulate along X and Y axes or at any angle, such that the tray can be placed into the surgical field at or about a patient's eye height for a Phaco surgical procedure without requiring movement of the patient.
25. The device of claim 18, further comprising a microscope integrated into the housing that is movable along x and y axes or at any angle such that the microscope can move in or out of position for a Phaco procedure.
9. The device of claim 1, further comprising a microscope integrated into the housing that is movable along x and y axes or at any angle such that the microscope can move in or out of position for a Phaco procedure.
26. The device of claim 25, wherein the microscope is coupled with the housing via a fourth articulating segment that permits rotational movement of the segment and microscope about the housing.
10. The device of claim 9, wherein the microscope is coupled with the housing via a fourth articulating segment that permits rotational movement of the segment and microscope about the housing.
27. The device of claim 18, wherein the housing comprises first and second portions, and wherein the Femto device or tray is stored about the first portion when not in use.
11. The device of claim 1, wherein the housing comprises first and second portions, and wherein the Femto device or tray is stored about the first portion when not in use.
28. The device of claim 18, wherein the Femto device and tray are each configured to articulate from a central column of the housing to permit articulation from a central point and allow the Femto device and tray to be placed into surgical position before, during and after surgery without requiring movement of a patient.
12. The device of claim 1, wherein the Femto device and tray are each configured to articulate from a central column of the housing to permit articulation from a central point and allow the Femto device and tray to be placed into surgical position before, during and after surgery without requiring movement of a patient.
29. The device of claim 18, wherein the articulation is circular in the horizontal.
13. The device of claim 12, wherein articulation from the central point is circular in the horizontal.
30. The device of claim 18, wherein the Femto device and tray is extendable and retractable relative to the housing in a vertical movement and can extend or retract and at any angle.
14. The device of claim 1, wherein the Femto device and tray is extendable and retractable relative to the housing in a vertical movement and can extend or retract and at any angle.
31. The device of claim 18, wherein the housing comprises a cylindrical shape having a central axis, and wherein each of the plurality of articulating segments are configured to articulate or rotate about the central axis.
15. The device of claim 1, wherein the housing comprises a cylindrical shape having a central axis, and wherein each of the plurality of articulating segments are configured to articulate or rotate about the central axis.
32. The device of claim 31, wherein the first segment has a first diameter and the second segment has a second diameter equal to the first diameter.
16. The device of claim 15, wherein the first segment has a first diameter and the second segment has a second diameter equal to the first diameter.
33. The device of claim 31, wherein each of the plurality of articulating segments have a cylindrical shape.
17. The device of claim 15, wherein each of the plurality of articulating segments have a cylindrical shape.
35. The device of claim 34, wherein the housing comprises Femto and Phaco surgical systems and interfaces and a controller for controlling the Femto and Phaco surgical systems.
2. The device of claim 1, wherein the Femto surgical device and the Phaco surgical system interface with a controller for controlling the Femto surgical device and Phaco surgical system.
36. The device of claim 34, wherein the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient.
3. The device of claim 1, wherein the controller permits a user to utilize both the Femto surgical device and Phaco surgical system without moving a patient.
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 18, 21-23-25, 28 and 31-32, are rejected under 35 U.S.C. 103 as being unpatentable over Gaida et al. (US 2008/0013048 A1, hereinafter "Gaida") in view of Buczek (Patent No. 6,736,360) and Kim et al. (Publication No. US 2018/0168547, hereinafter “Kim”).
Regarding claim 18, Gaida discloses a combination Femto laser (Femto) and Phacoemulsification (Phaco) surgical device, comprising:
a. a housing having a plurality of articulating segments (Fig. 2 (3), (8)), wherein each of the segments is movable with respect to the housing;
b. wherein a first segment of the plurality of articulating segments is coupled to a Femto device via an articulating arm (par. [0011], claim 5: …the console has at least one additional apparatus which is selected from the group which includes…a laser coagulation apparatus…);
e. a display disposed on a portion of the housing (Fig. 2 (11));
f. wherein the first segment and the second segment are independently movable about the housing (Fig. 2, and par. [0033]: …the holding arm 3 and the foot switch assembly arm 8 …can be pivoted about an axis 20 within the console 4); and
g. wherein the Femto device and the tray can move and articulate with respect to one other, such that movement of a patient is not required between Femto and Phaco procedures (pars. [0011] … the console has at least one additional apparatus which is selected from the group which includes a phacoemulsification apparatus, a vitrectonomy apparatus, a laser coagulation apparatus,…Each additional apparatus is provided with an additional foot switch. Other additional apparatus which are needed for ophthalmology can be provided in the console… With the integration of one or several additional apparatus in a console, it is possible to provide a unitary operator control, [0034]: … the holding arm 3 and the foot switch assembly 5 have been pivoted about the console 4 by 1800).
Gaida does not disclose c. wherein a second segment of the plurality of articulating segments is coupled to a tray configured to hold a set of hand pieces for use in phacoemulsification; and
d. wherein a third segment of the plurality of articulating segments is coupled with a keyboard, keyboard tray or both;
However Buczek, in the same field of endeavor: rotary jointed arm for a surgical tray, discloses c. a second segment of the plurality of articulating segments is coupled to a tray (FIG. 1 (10) and col. 2, ln. 62 - col. 3, ln. 10: …surgical tray 10 that can be used with the arm mechanism of the present invention generally is connected or attached to surgical console 100…Tray 10 generally contains body 11 …Body 11 may also have one or more recesses 15 to accommodate various handpieces and tools used during a surgical procedure…Tray 10 is connected to console 100 by arm mechanism 1) configured to hold a set of hand pieces for use in phacoemulsification (FIG. 1 (11) and col. 2, ln. 62 - col. 3, ln. 10: …Tray 10 generally contains body 11 …Body 11 may also have one or more recesses 15 to accommodate various handpieces and tools used during a surgical procedure…Tray 10 is connected to console 100 by arm mechanism 1) to provide the benefit of accessing the tray with handpieces from either side of console (col. 3, lns. 10-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser arm, as taught by Gaida, to include a tray on an articulating arm for holding phacoemulsification handpieces, as taught by Buczek, in order to provide the benefit of accessing handpieces from either side of console.
The Gaida and Buczek combination does not disclose
d. wherein a third segment of the plurality of articulating segments is coupled with a keyboard, keyboard tray or both.
However, Kim in the same field of endeavor: a swivel device of a tray for a medical apparatus, discloses a third segment of the plurality of articulating segments is coupled with a keyboard (Fig. 2, (110) (130)) for providing the benefit of enhancing the convenience for users (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser arm and a tray on an articulating tray for holding phacoemulsification handpieces, as taught by Gaida and Buczek, to include a segment with a keyboard attached as taught by Kim, in order to enhance the convenience of users.
Regarding claim 21, the Gaida and Buczek combination discloses all of the device of claim 5 except wherein the keyboard or keyboard tray is configured to move in a vertical X movement and horizontal Y movement or any angle with or independently from the Femto laser head.
Kim discloses the keyboard is configured to move in any angle with or independently from the Femto laser head (Figs. 1, 7 and 8 and Abstract) for the benefit of enhancing the convenience for users (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to add to the laser therapy instrument containing an articulating femtolaser arm and an articulating phacoemulsification tray as taught by Gaida and Buczek, a segment containing a swivel keyboard configured to move in a transverse direction as taught by Kim in order to enhance the convenience of users.
Regarding claim 22, the Gaida and Buczek combination discloses all of the device of claim 21 except wherein the keyboard or keyboard tray is configured to move in a vertical X movement and horizontal Y movement or any angle with or independently from the Femto laser head.
Kim discloses the keyboard is configured to move in any angle with or independently from the Femto laser head (Figs. 1, 7 and 8 and Abstract) for the benefit of enhancing the convenience for users (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to add to the laser therapy instrument containing an articulating femtolaser arm and an articulating phacoemulsification tray as taught by Gaida and Buczek, a segment containing a swivel keyboard configured to rotate in a transverse direction as taught by Kim in order to enhance the convenience of users.
Regarding claim 23, the Gaida and Kim combination discloses the device of claim 18. While the combination discloses a Phaco hand piece, a vitrectomy (VIT) hand piece, an irrigation hand piece and an aspiration hand piece (par. [0011]), it does not expressly disclose the tray is configured to hold a Phaco hand piece, a vitrectomy (VIT) hand piece, an irrigation hand piece and an aspiration hand piece.
Buckzek discloses the tray is configured to hold a Phaco hand piece, a vitrectomy (VIT) hand piece, an irrigation hand piece and an aspiration hand piece (Fig. 1 (10) and col. 2, ln. 62 - col. 3, ln. 10: …surgical tray 10 that can be used with the arm mechanism of the present invention generally is connected or attached to surgical console 100…Tray 10 generally contains body 11 …Body 11 may also have one or more recesses 15 to accommodate various handpieces and tools used during a surgical procedure…Tray 10 is connected to console 100 by arm mechanism 1) to provide the benefit of accessing the tray with handpieces from either side of console (col. 3, lns. 10-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the Femto Phaco device containing ophthalmic handpieces of Gaida, and Kim, a tray to accommodate various handpieces, as taught by Buczek, in order to access the tray with handpieces from either side of console.
Regarding claim 24, the Gaida and Kim combination discloses the device of claim 18, except wherein the tray is configured to articulate along X and Y axes or at any angle, such that the tray can be placed into the surgical field at or about a patient's eye height for a Phaco surgical procedure without requiring movement of the patient.
Buczek discloses the tray is configured to articulate along X and Y axes or at any angle, such that the tray can be placed into the surgical field at or about a patient's eye height for a Phaco surgical procedure without requiring movement of the patient (col, 1, ln. 60 – col. 2, ln. 3: The present invention improves upon the prior art by providing a movable arm for a surgical tray that is connected to the surgical console, is adjustable for height and allows for full, unlimited 360.degree. rotation of the tray) to provide the benefit of accessing the tray with handpieces from either side of console (col. 3, lns. 10-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser arm, as taught by Gaida and Kim, to include a tray on an articulating arm for holding phacoemulsification handpieces, as taught by Buczek, in order to provide the benefit of accessing handpieces from either side of console.
Regarding claim 25, the Gaida, Buczerk and Kim combination discloses the device of claim 18, further comprising a microscope integrated into the housing (Gaida, Fig. 2 an par. [0033]: At the distal end of the holding arm 3, a microscope 2 is mounted and the eye 15 of the patient 14, which is to be operated on, lies in the beam path of the microscope) that is movable along x and y axes or any angle such that the microscope can move in or out of position for a Phaco procedure (Gaida, Fig. 2 (21) and par. [0030]: …microscope 2 with the eye 15 of the patient 14, …adjustment of the holding arm 3 in the vertical direction is provided…).
Regarding claim 28, the Gaida and Kim combination discloses the device of claim 18, wherein the Femto device and tray are each configured to articulate from a central column of the housing to permit articulation from a central point (Gaida, Fig. 2 (20)) and allow the Femto device and tray to be placed into surgical position before, during and after surgery without requiring movement of a patient (Gaida, par. [0033]: …the holding arm 3 and the foot switch assembly arm 8…can be pivoted about an axis 20 within the console 4).
Regarding claim 31, the Gaida, Buczek and Kim combination discloses the device of claim 1, wherein the housing comprises a cylindrical shape having a central axis (Gaida, Fig. 2 (4))wherein each of the plurality of articulating segments are configured to articulate or rotate about the central axis (Gaida, Fig. 2 (20)).
Regarding claims 32, the Gaida, Buczek and Kim combination discloses the device of claim 31, wherein the first segment has a first diameter and the second segment has a second diameter equal to the first diameter (Gaida, Fig. 2 (12)).
Claims 19-20, are rejected under 35 U.S.C. 103 as being unpatentable over Gaida in view of Buczek as applied to claims 18, 21 -25, 28 and 31-32 above, and further in view of Patton (US 2013/0090636 A1).
Regarding claim 19, the Gaida, Buczek and Kim combination disclose the device of claim 18, wherein the housing comprises Femto and Phaco surgical systems and interfaces (Gaida, pars. [0011], claim 5: …the console has at least one additional apparatus which is selected from the group which includes a phacoemulsification apparatus, a vitrectonomy apparatus, a laser coagulation apparatus…, [0028]: …a phacoemulsification apparatus can be integrated into the console 4).
The combination does not disclose interfaces and a controller for controlling the Femto and Phaco surgical systems.
However, Patton in the same field of endeavor: systems and methods for combined Femto-Phaco for ophthalmic surgery, discloses Femto and Phaco surgical system interfaces and a controller for controlling the Femto and Phaco surgical systems (Figs. 11-15 and [0036]: … a single GUI and/or software can combine control of ophthalmic phacoemulsification and femtolaser functionalities, [0043]: …a device that combines femtolaser ablation functionality and phacoemulsification functionality) to provide the benefit of preventing translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient (par. [0009]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the ophthalmologic console capable of having multiple arms including both femtolaser and phacoemulsion apparatus an arm mechanism with a surgical tray for various handpieces, and an articulating member with a keyboard, as taught by Gaida, Buczek and Kim, to include combined control of ophthalmic phacoemulsification and femtolaser functionalities, as taught by Patton, in order to prevent translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Regarding claim 20, the Gaida, Buczek and Kim combination discloses all of the device of claim 18, except wherein the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient.
Patton discloses the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient (Fig. 16 and par. [0044]: … a device that combines femtolaser ablation functionality and phacoemulsification functionality, using a common GUI control platform) to provide the benefit of preventing translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the Femto Phaco device of Gaida, Buczek and Kim a GUI control that uses a Phaco and Femto together, as taught by Patton, in order to prevent translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Claims 26 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over the Gaida in view of Welches, Buczek and Kim as applied to claims 18, 21-25, 28 and 31-32 above, and further in view of Horvath et al. (Publication No. US 2012/0316544, hereinafter “Horvath”).
Regarding claim 26, the Gaida, Buczek and Kim combination discloses the device of claim 25, wherein the microscope is coupled with the housing (Gaida, Fig. 2 (2)). The combination does not teach a fourth articulating segment that permits rotational movement of the segment and microscope about the housing.
However, Horvath in the same field of endeavor: a laser delivery system for use in eye surgery, discloses an articulating segment that permits rotational movement of the segment and microscope about the housing (Fig. 16 (102), (103), (104), (260), (261) and pars. [0075], [0076]). This is for the benefit of allowing the delivery system unit to be moved between around with the microscope without affecting the laser beam alignment entering the delivery system unit (par. [0076]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include with the microscope coupled with the housing as taught by the Gaida, Buczek and Kim, an additional articulating arm segment as taught Horvath, in order to allow the delivery system unit to be moved between around with the without affecting the laser beam alignment entering the delivery system unit.
Regarding claim 33, the the Gaida, Buczek and Kim combination discloses the device of claim 31 except, each of the plurality of articulating segments have a cylindrical shape.
Horvath discloses each of the plurality of articulating segments have a cylindrical shape (Fig. 16 articulating arm (102)).
The combination teaches articulating segments. The substitution of one known element cylindrical shaped articulating segments as taught by Horvath for rectangular shaped articulations as taught by the Gaida, Buczek and Kim combination would have been obvious to one of ordinary skill in the art at the filing date of the invention since the substitution would have yielded predictable results, namely, movable articulating arms. In addition, cylindrical articulating segments (Fig. 16, (102)) has also been taught by Horvath to have the benefit of providing attachments of the surgical equipment to the laser engine (Horvath, par. [0058]).
Claims 27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over the Gaida in view of Welches and Kim as applied to claims 18, 21-25, 28 and 31-32 above, and further in view of Murphy et al. (Publication No. US 2001/0035702, hereinafter “Murphy”).
Regarding claim 27, the Gaida, Buczek and Kim combination discloses all of the device of claim 18 except wherein the housing comprises first and second portions, and wherein the Femto device or tray is stored about the first portion when not in use.
However, Murphy in the same field of endeavor: a cart for surgical console containing various portions, discloses, the housing comprises first and second portions (Fig. 5, (22), (28), (38)), and wherein the Femto device or tray is stored about the first portion (Fig. 5 (38)) when not in use (Figs. 1 and 3 and par. [0023]). This is for the purpose of moving the tray from a stored position to an in use position (par. [0023])
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical device housing, as taught by the Gaida, Welches, Buczek and Kim, to include various portions where one of the portions includes an internal volume for receiving a tool tray as taught by Murphy in order to move the tray from a stored position to an in use position.
Regarding claim 29, the Gaida, Buczek and Kim combination discloses the device of claim 18, except wherein the articulation is circular in the horizontal.
Murphy discloses the articulation is circular in the horizontal (Fig. 3 swing arm (42) and par. [0023]), for the purpose of circulating the tray from a stored position within the internal housing volume to a position for use (par. [0023]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical device housing, as taught by Gaida, Buczek and Kim to include various portions where one of the portions includes an internal volume for receiving a tool tray as taught by Murphy in order to circulate the tray from a stored position within the internal housing volume to a position for use.
Regarding claim 30, the Gaida and Buczek and Kim combination discloses the device of claim 18 except wherein the Femto device and tray is extendable and retractable relative to the housing in a vertical movement and can extend or retract and at any angle.
Murphy discloses the Femto device and tray is extendable and retractable relative to the housing in a vertical movement and can extend or retract and at any angle (Fig. 3 swing arm (42), tray (40), (44) and par. [0023]). This provides the benefit of allowing the tray to be moved to an optimal position for use by the surgeon or surgical staff (par. [0023]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate with the articulating tray that can extend and retract as taught by the combination of Gaida and, Buczek and Kim, a portion that is capable of vertical movement as taught by Murphy, to allow the tray to be moved to an optimal position for use by the surgeon or surgical staff.
Claims 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Gaida et al. (US 2008/0013048 A1, hereinafter "Gaida") in view of Welches et al. (Publication No. US 2012/0022510, hereinafter “Welches”) and further in view of Buczek (Patent No. 6,736,360) and Kim et al. (Publication No. US 2018/0168547, hereinafter “Kim”).
Regarding claim 34, Gaida discloses a combination Femto laser (Femto) and Phacoemulsification (Phaco) surgical device, comprising:
a. a housing (Fig. 2 (4)) having a plurality of segments (Fig. 2 (3), (8)), wherein each of the segments is movable with respect to the housing (Fig. 2, and par. [0033]: …the holding arm 3 and the foot switch assembly arm 8 …can be pivoted about an axis 20 within the console 4);
b. wherein a first segment of the plurality of segments is coupled to a Femto device via an articulating arm (par. [0011], claim 5: …the console has at least one additional apparatus which is selected from the group which includes…a laser coagulation apparatus…);
f. a display disposed on a portion of the housing (Fig. 2 (11)); and
g. wherein the first segment and the second segment are independently rotatable about the housing (Fig. 2, and par. [0033]: …the holding arm 3 and the foot switch assembly arm 8 …can be pivoted about an axis 20 within the console 4).
Gaida does not disclose b. wherein the Femto device comprising a Femto laser head and one or more accelerometers configured to provide x, y, and z position data of the Femto laser head;
c. a memory device communicatively coupled to the one or more accelerometers and configured to record a use position of the Femto head as x, y, and z coordinates in three dimensional space and to transmit the use position following use of Phaco surgical device;
d. wherein a second segment of the plurality of articulating segments is coupled to a tray configured to hold a set of hand pieces for use in phacoemulsification; and
e. wherein a third segment of the plurality of articulating segments is coupled with a keyboard or keyboard tray.
However, Welches in the same field of endeavor: a laser surgical device including a handpiece including laser energy discloses b. the Femto device comprising a Femto laser head and one or more accelerometers (Fig. 3B (300), (305)) configured to provide x, y, and z position data (Fig. 3A and par. [0084]: …the device translating acceleration in one, two, or three axes and FIG. 3B shows an embodiment of the accelerometer mounted on to a device of the present invention) of the Femto laser head (Fig. 3B and pars. [0130], [0136]: …the device 300 includes a three-axis accelerometer 305 located in the laser/surgical hand piece 310 and a translator processing circuit 315, which translates acceleration into…position…); and
c. a memory device communicatively coupled to the one or more accelerometers (Fig. 3B (305), (315)) and configured to record a use position of the Femto head as x, y, and z coordinates in three dimensional space and to transmit the use position following use of Phaco surgical device (par. [0148]: Location of each shot locked to an absolute position can be recorded throughout the procedure…) for the purpose of returning the laser to missed or untreated areas for a more evenly distributed energy treatment (par. [0136]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser arm, as taught by Gaida, to include an accelerometer on the laser surgical tool as taught by Welches, in order to return the laser to missed or untreated areas for a more evenly distributed energy treatment
The Gaida and Welches combination does not disclose d. wherein a second segment of the plurality of articulating segments is coupled to a tray configured to hold a set of hand pieces for use in phacoemulsification; and
e. wherein a third segment of the plurality of articulating segments is coupled with a keyboard or keyboard tray.
However, Buczek, in the same field of endeavor: rotary jointed arm for a surgical tray, discloses a segment of the plurality of articulating segments is coupled to a tray (FIG. 1 (10) and col. 2, ln. 62 - col. 3, ln. 10: …surgical tray 10 that can be used with the arm mechanism of the present invention generally is connected or attached to surgical console 100…Tray 10 generally contains body 11 …Body 11 may also have one or more recesses 15 to accommodate various handpieces and tools used during a surgical procedure…Tray 10 is connected to console 100 by arm mechanism 1) configured to hold a set of hand pieces for use in phacoemulsification (FIG. 1 (11) and col. 2, ln. 62 - col. 3, ln. 10: …Tray 10 generally contains body 11 …Body 11 may also have one or more recesses 15 to accommodate various handpieces and tools used during a surgical procedure…Tray 10 is connected to console 100 by arm mechanism 1) to provide the benefit of accessing the tray with handpieces from either side of console (col. 3, lns. 10-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser with accelerometer, as taught by Gaida and Welches, to include a tray on an articulating member for holding phacoemulsification handpieces, as taught by Buczek, to provide the benefit of accessing the tray with handpieces from either side of console. ; and to enhance the convenience of users.
The Gaida, Welches and Buczek combination do not disclose e. wherein a third segment of the plurality of articulating segments is coupled with a keyboard or keyboard tray.
However, Kim in the same field of endeavor: a swivel device of a tray for a medical apparatus, discloses a swivel device includes a base (Fig. 2, (110)), a tray (Fig. 2, (130)) with a keyboard attached (Fig. 1, (42)) configured to relatively rotate with respect to base (Figs. 7 and 8 and Abstract). This provides the benefit of enhancing the convenience for users (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the laser therapy instrument containing an articulating femtolaser with accelerometer and an articulating tray for phacoemulsification tools, as taught by Gaida, Welches and Buczek, to include a segment with a keyboard attached as taught by Kim, in order to enhance the convenience of users.
Regarding claim 37, the Gaida, Welches, Buczek and Kim combination disclose the device of claim 34, wherein the Femto device and the tray can move and articulate with respect to one other, such that movement of a patient is not required between Femto and Phaco procedures (Gaida, pars. [0011] … the console has at least one additional apparatus which is selected from the group which includes a phacoemulsification apparatus, a vitrectonomy apparatus, a laser coagulation apparatus,…Each additional apparatus is provided with an additional foot switch. Other additional apparatus which are needed for ophthalmology can be provided in the console… With the integration of one or several additional apparatus in a console, it is possible to provide a unitary operator control, [0034]: … the holding arm 3 and the foot switch assembly 5 have been pivoted about the console 4 by 1800).
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Gaida in view of Welches, Buczek and Kim as applied to claims 18, 21-25, 28 and 31-32 above, and further in view of Patton (US 2013/0090636 A1).
Regarding claim 35, the Gaida, Welches, Buczek and Kim combination disclose the device of claim 34, wherein the housing comprises Femto and Phaco surgical systems and interfaces and a controller for controlling the Femto and Phaco surgical systems (Gaida, pars. [0011], claim 5: …the console has at least one additional apparatus which is selected from the group which includes a phacoemulsification apparatus, a vitrectonomy apparatus, a laser coagulation apparatus…, [0028]: …a phacoemulsification apparatus can be integrated into the console 4).
The combination does not disclose interfaces and a controller for controlling the Femto and Phaco surgical systems.
However, Patton in the same field of endeavor: systems and methods for combined Femto-Phaco for ophthalmic surgery, discloses interfaces and a controller for controlling the Femto and Phaco surgical systems (Figs. 11-15 and [0036]: … a single GUI and/or software can combine control of ophthalmic phacoemulsification and femtolaser functionalities, [0043]: …a device that combines femtolaser ablation functionality and phacoemulsification functionality) to provide the benefit of preventing translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient (par. [0009]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the ophthalmologic console capable of having multiple arms including both femtolaser and phacoemulsion apparatus an arm mechanism with a surgical tray for various handpieces, and an articulating member with a keyboard, as taught by Kim, as taught by Gaida, Welches, Buczek and Kim, to include combined control of ophthalmic phacoemulsification and femtolaser functionalities, as taught by Patton, in order to prevent translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Regarding claim 36, the Gaida, Buczek and Kim combination discloses all of the device of claim 34, except wherein the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient.
Patton discloses the controller permits a user to utilize both the Femto and Phaco surgical systems without moving a patient (Fig. 16 and par. [0044]: … a device that combines femtolaser ablation functionality and phacoemulsification functionality, using a common GUI control platform) to provide the benefit of preventing translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the Femto Phaco device of Gaida, Welches, Buczek and Kim a GUI control that uses a Phaco and Femto together, as taught by Patton, in order to prevent translocation and re-setup of the patient during surgery and thus decreasing the time required for the procedure, and undue stress on the patient.
Conclusion
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/AAA/ Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792