The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Initially, it is noted that this application is now being prosecuted by a different examiner from whom examined it prior to this Office Action. As such, any objections and/or rejections that were previously made but are not found within this Office Action are considered withdrawn.
Response to Arguments
In view of the appeal brief filed on June 10, 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Claim Interpretation
With respect to claim 1, it is noted that it would be an inherent of a typical phacoemulsification system, which has no optical components, that if/when combined with a laser (or other optical system) within a housing, that the laser system would have optical components that are isolated from the phacoemulsification system. This is, again, because an ultrasonic phacoemulsification system does not utilize optical features. Therefore, this is an inherent feature in any applied prior art reference.
With respect to claim 1, it is noted that it would be an inherent of a typical phacoemulsification system, which has no optical components, that if/when combined with a laser (or other optical system) within a housing, that the ultrasonic vibratory components of the phacoemulsification system would be isolated from the laser system, which typically does not contain moving parts. A laser relies on a reflecting chamber to generate the laser energy and relies on mirrors or optical fibers to direct the laser beam. At most there may be the movement of mirrors, lenses, prisms, etc., within an optical system. However, the ultrasonic vibratory components of a phacoemulsification system would not be integrated into, and physically combined with these components in a laser system that would impart laser energy on the eye of a patient, which relies on precise beam placement. This is, again, because laser system does not utilize vibratory energy for delivering therapeutic results and instead, relies on non-vibratory means to deliver laser energy to precise locations. Therefore, mechanical isolation of the phacoemulsification system from a laser system, within a combined unit, would be inherent feature in any applied prior art reference.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the subject matter of a “third configuration” as recited in claims 64 and 65 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9, 15, 19-21, 30, 52 and 69 are objected to because of the following informalities:
Claim 9 is objected to because it is unclear to what “a PID” refers. This acronym should be spelled out in full the first time it appears in the claims. It is noted that within the specification, this is a “patient interface device”.
Claims 19-20 are objected to because “phacoemulsification producer” in the last line is likely supposed to read “phacoemulsification procedure”.
Claims 21 is objected to because there should not be an “a” in line two where it reads “wherein the system is configured to provide a two therapeutic laser beams”.
Claim 30 is objected to because “preformed” in part (b) should state “performed”. Additionally, the “and” in part (b) should be removed.
Claim 52 is objected because, in the last line, “form” should state “from”.
Claim 69 is objected to because “preformed” in line 2 should state “performed”.
Appropriate correction is required.
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. Specifically, where claim 15 depends from any one of claims 10, 11, 12 or 13, this is a duplicate claim to that of claim 14.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-29, 31-61 and 66-69 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected because it is unclear how “the therapeutic laser system and the phacoemulsification system are electrically… isolated”, as stated in part (iii), when they “have a common power source”. In other words, if they have a common power source then they cannot be isolated electrically. Even if they are connected in parallel to the power source, they are tied to the same power source and are not isolated from one another.
Claim 1 is rejected it is unclear what is meant by “whereby the operation of either system does not interfere electrically, optically and mechanically with the operation of the other”. It appears this is further attempt at explaining what is meant by these three features being “isolated” in the wherein clause that precedes this statement. However, this does not provide additional clarity to the claim, and instead creates confusion. It is recommended that part (iv) of claim 1 be amended to more directly claim what this section intends to claim.
Claims 16-17 are rejected because this claim recites that “the laser cannot be fired when the phacoemulsification system is in use”, but claim 1, part (iv) recites that “the operation of either system does not interfere electrically, optically and mechanically with the operation of the other”. These two recitations are at odds, because if the laser cannot fire when the phacoemulsification system is in use, then the overall system is providing interference between these two subsystems. As such, claims 16-17 contradict the recitations of claim 1.
Claim 9 is rejected because it is unclear what is meant by “meniscus inverter”. The specification fails to provide any detailed description of this feature/component. Additionally, this is given the reference numeral 1209, which appears only in Figure 12D and points to a single circular ridge within the overall structure, which provides little, to no, clarity with respect to defining this feature. This term does not appear to be a term of art, and is not used in any other discoverable reference within ophthalmology. For these reasons, the claim term is unclear and indefinite.
Claim 31 is rejected because it is unclear if “i. a therapeutic laser system…” is the same or different from “a therapeutic laser system” in line 2 of claim 30.
Claim 31 is rejected because it is unclear if “ii. a phacoemulsification system…” is the same or different from “a phacoemulsification system” in line 2 of claim 30.
Claim 37 is rejected because it recites “The system of any of claims 35 or 36, wherein the means for determining a shape, a position of both of a structure of an eye…” lacks antecedent basis in the situation where this claim depends from claim 36. This claim should not be dependent from multiple claims, but only from claim 35.
Claims 66-67 are rejected because it is unclear what makes the system “non-handed”. In other words, it is unclear what is structurally unique that provides for no distinction of use for a right-handed person versus a left-handed person.
Claim 69 is rejected because “The method of…” lacks antecedent basis since there is no previous method claim. This should state “A method”.
Any claim not explicitly addressed above is rejected at least based on its dependency from one of the claims that are explicitly addressed, thereby containing the same issues.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-15, 18-20, 31-33, 39-41, 53-61 and 66-69 are rejected under 35 U.S.C. 103 as being unpatentable over Patton (WO 2019/083704) in view of Patton’636 (US Patent Pub. No. 2013/0090636).
Regarding claim 1, Patton discloses systems and methods for combined femto-phaco surgery (see Title). The system of Patton comprises:
An assembly defining a foot print and a volume (see Figures 1-8, which illustrates an assembly which has a foot print (i.e., it takes up space on the floor) and a volume (i.e., it also includes a height, as well as the space that is taken up on the floor);
The assembly comprising:
A therapeutic laser system configured to provide a therapeutic laser beam (see paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification);
A phacoemulsification system configured to provide therapeutic ultrasonic energy (see paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification);
Wherein the therapeutic laser system and the phacoemulsification system have a common power source (note that Figure 16 illustrates the internal components, which is only taught as having a single power source 156, therefore making it obvious that this one power source is a shared, common power source; also see paragraph 19 which only states a single power supply), a common control system (see the secondary reference) and a common GUI for receiving instructions and displaying information (see paragraph 43, “the combined Phaco/Femto interface 200 presents both Femto and Phaco controls with the addition of a middle combined menu that illustrates integration systems”, also see paragraph 39);
iv. wherein the therapeutic laser system and the phacoemulsification system are electrically, optically and mechanically isolated; whereby the operation of either system does not interference electrically, optically and mechanically with the operation of the other (it is noted that Figure 16 clearly illustrates that the laser system 140, 142 and 144 are physically offset from the phaco system 150, 152 and 154 within the unit; therefore these are obviously isolated from one other mechanically, electrically and optically with the clear exception of a common power source and GUI); and,
Wherein the foot print is less than 1,500 sq inches (noting that this is equivalent to a square area of 3.2 ft by 3.2 ft; it is noted that Figures 12-14 illustrate the device proximate a user, from which comparisons of the size of the apparatus versus the size of the user shows that the footprint is about 3ft2 or less).
It is noted that in describing Figure 16, Patton teaches that unit 154 is a phaco controller. Therefore, this does not clearly teach a common controller.
Patton’636 teaches systems and methods for combined femto-phaco cataract surgery (see Title). In Figure 17, Patton’636 illustrates a combined system in which there is a common GUI and distinct phaco system and femto system that each have their own CPU. However, Figure 16 illustrates another embodiment in which the phaco system and femto system are combined into a single housing in which there is only a single CPU, implying that they would now share this component. Additionally, paragraph 36 teaches that “it is contemplated that a single GUI and/or software can combine control of ophthalmic phacoemulsification and femtolaser functionalities for cataract removal.” While paragraph 37 states that “FIG. 11 is a schematic of a graphical user interface of software configured to control both a femtolaser ablation device and a phacoemulsification device.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a common control system, as taught by Patton’636, within the system and methods of Patton, because doing so will reduce the number of components necessary to build the product, which will reduce costs and complexity.
Regarding claims 2-5, as can be seen in Figures 14-15 of Patton, the size of the device as seen from above is about the size of a person sitting in a chair. Therefore, this is “about 33/35/35 inches by about 22/35/22 inches” respectively, and 400 sq inches to about 800 sq inches. Also, it is noted that MPEP 2144.04(IV)(A) states that “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.”
Regarding claims 6-9 (and also additional discussion regarding claims 2-5), it is noted that Figure 16 of Patton illustrates the height of the two separate cylinder portions as 41 inches and 55 inches, and also that these are both elevated from the floor by wheels. Therefore, if assuming the foot print is about 2.5 ft x about 2.5 ft with a height of 48 inches (an average of 41 and 55 inches), this would be a volume of about 25 ft3. It is obvious that this is an approximation, but it is re-iterated that MPEP 2144.04(IV)(A) states that “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” The purpose of the inventions of both Pattons is to provide a single device that can be portable and easily brought from operating room to operating room, providing close proximity to the patient, while containing all components necessary to perform surgery with both phacoemulsification devices and laser devices. This obviously requires an overall device that is compact and easily maneuverable through doorways, while being a reasonable height for users to operate while standing and/or sitting. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this would meet the dimensions of the claims, for each of claims 2-8.
Regarding claims 10-15, Figure 16 of Patton clearly illustrates the phaco system and the laser system contained within the same, single overall housing 102.
Regarding claim 18, it is noted that both titles of both Patton references mention a femto system, which refers to a femtosecond laser system.
Regarding claims 19-20, Patton teaches “a microscope 50 is shown adjacent to the device 100, it is contemplated that the microscope 50 could be integrated into the device 100” (see paragraph 34). Additionally, numeral 204 in Figure 11 illustrates a “still image or live video 204 of a patient's eye” which has obviously been captured by the microscope.
Regarding claim 31, Patton teaches
a. an assembly (see housing 102 in numerous Figures), the assembly comprising: i. an therapeutic laser system for providing and directing the therapeutic laser beam along a laser beam path; ii. A phacoemulsification system for providing therapeutic ultrasonic energy for performing the phacoemulsification procedure (see paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification); iii. The therapeutic laser system and the phacoemulsification system operably associated with a common control system (see the incorporation of Patton’636 above in the rejection of claim 1);
b. an arm attached to the assembly (see articulated arm 9); i. the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly (see Figure 3 for distal and proximal ends); ii. Wherein the proximal end has a laser delivery head (see Femto laser head 11 on distal end in Figure 3); iii. Wherein the arm contains a portion of the laser beam delivery path (“The Femto device 110 preferably includes an articulated optical arm 9 coupled to the swivel 5”, see paragraph 24);
c. wherein the arm is movable to a first position corresponding to the first configuration, and moveable to a second position corresponding to the second position (see Figures 4, 12-13 as contrasted to that of Figures 14-15 of Patton).
Regarding claims 32-33, it is noted that the articulated arm is extended away from the assembly in the first position (see Figures 4, 12-13 of Patton), and the assembly is contained within a housing (see Figure 16 of Patton).
Regarding claim 39, see Figure 16 of Patton, illustrating these all contained in a same housing, along with Patton’636 illustrating the same in Figure 16.
Regarding claims 40-41, it is noted that the articulated arm is extended horizontally and proximally away from the housing in the first position (see Figures 4, 12-13 of Patton), and the assembly is contained within a housing (see Figure 16 of Patton).
Regarding claims 53-60, it is re-iterated that Figures 12-14 illustrate the device proximate a user, from which comparisons of the size of the apparatus versus the size of the user shows that the footprint is about 3 ft2 or less (i.e., 2.5 ft x 2.5 ft). And as can be seen in Figures 14-15 of Patton, the size of the device as seen from above is about the size of a person sitting in a chair. Also, it is noted that MPEP 2144.04(IV)(A) states that “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” It is also noted that Figure 16 of Patton illustrates the height of the two separate cylinder portions as 41 inches and 55 inches, and also that these are both elevated from the floor by wheels. Therefore, if assuming the foot print is about 2.5 ft x about 2.5 ft with a height of 48 inches (an average of 41 and 55 inches), this would be a volume of about 25 ft3. It is obvious that this is an approximation, but it is re-iterated that MPEP 2144.04(IV)(A) states that “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” The purpose of the inventions of both Patton references is to provide a single device that can be portable and easily brought from operating room to operating room, providing close proximity to the patient, while containing all components necessary to perform surgery with both phacoemulsification devices and laser devices. This obviously requires an overall device that is compact and easily maneuverable through doorways, while being a reasonable height for users to operate while standing and/or sitting. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this would meet the dimensions of these claims.
Regarding claim 61, it is noted that both titles of both Patton references mention a femto system, which refers to a femtosecond laser system.
Regarding claim 66, it is noted that a surgeon may use this system whether he/she is left-handed or right-handed.
Regarding claim 67, it is re-iterated that a surgeon may use this system whether he/she is left-handed or right-handed. Additionally, Patton teaches “As shown in Figure 7, the second portion 30 of the housing 102 can comprise a Phaco fluidics module and cassette 19” (see paragraph 32), and also that there is a phaco surgical tray 16 (see paragraph 31).
Regarding claim 68, Patton teaches that “Device 100 further comprises a foot pedal 23 for control of the procedures. Preferably the foot pedal 23 is wirelessly connected to the device 100 and therefore can be moved as needed” (see paragraph 33).
Regarding claim 69, it is noted that Patton teaches the system as described above with regard to the rejection of claim 1 (and all others), in which it is described that this device is used in “performing a surgery”.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 1-2 above, and further in view of L’Esperance, Jr. (US Patent No. 5,257,988).
Patton in combination with Patton’636 is described above with respect to claims 1-2. However, the Patton references do not explicitly teach a laser interlock as claimed.
L’Esperance teaches an instrument for ophthalmic surgery. Specifically, L’Esperance teaches an “interlock switch 56 [that] is shown with connection to the laser-control means 64 whereby, regardless of the foot-operated positioning of the master-control element 61, there can be no laser discharge into chamber 40, unless chamber 40 is certified (by switch 56) to have been fully closed at port 12” (see column 4, lines 33-38). It is noted that side port 12 is used for aspiration (see column 5, lines 30-42; also see column 4, line 65 through column 5, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a laser interlock, as taught by L’Esperance, within the system and methods of the Patton reference, in order to prevent the laser from firing while other aspects of the device are operative and may cause improper positioning of the laser spot, such as during aspiration of lens debris that is being removed from the eye. To this effect, it is noted that in Patton, paragraph 32 describes the various components associated with phaco portion of the system, which includes “for example, a Phaco connector 20, an aspiration connector 21, and an irrigation connector 22”. In other words, aspiration of the eye and surgical area occurs with the phaco components in the system of Patton, and the use of the interlock as described by L’Esperance (i.e., during aspiration) within the system of Patton would result in the interlock preventing laser energy from being delivered during phacoemulsification.
Finally, it is also noted that the “whereby” limitations in claims 16 and 17 are functional limitations and/or intended use. That is, these claims positively recite a laser safety interlock, which is a structural component that adds to the system of claims 1 or 2. However, “whereby the laser cannot be fired when the phacoemulsification system is in use” (1) presents functional language that is not actually tied to the interlock at all, and (2) presents intended use of the interlock (if it assumed that the interlock is performing this function), in that the interlock is intended to function in this capacity. With this in mind, the fact that L’Esperance teaches a laser interlock in a phacoemulsification device reads on the actual structural limitations added by claims 16-17, thereby reading on the claims.
Claims 30, 46-51, 62, 64 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Patton alone.
Regarding claim 30, Patton discloses an integrated reconfigurable laser-ultrasound system, the system comprising: a therapeutic laser system (see paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification), a phacoemulsification system (see paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification), and a rigid laser beam delivery arm mechanically associated with a housing (see articulated arm 9, see paragraph 24); and, wherein the system has two predetermined configurations:
A first configuration for providing a therapeutic laser beam to a patient (see “Femto arrangement” in Figures 4 and 12-13);
A second configuration for performing a phacoemulsification procedure to a patient (see “Phaco arrangement” in Figures 14-15); and,
Wherein the first configuration is different from the second configuration (see that Figures 4, 12-13 are different and differently labeled from that of Figures 14-15); and,
Wherein the integrated reconfiguration laser-ultrasound system is configured to provide for a transition from the first configuration to the second configuration in less than 5 minutes, and from the second configuration to the first configuration in less than 5 minutes (see paragraph 43).
Further regarding the recitations of “less than 5 minutes” in claim 30, as well as with regard to each of claims 46-51, it is noted that Patton employs “swivel technology that allows a practitioner to easily articulate radially the Femto and Phaco arms into position during surgery without requiring patient movement” (see paragraphs 7). Also see paragraphs 8, 28, and 39. These paragraphs, while not stating that this switch is “less than 5 minutes”, make it clear that this system is constructed to allow a doctor to easily and quickly make this switch, with motorized swiveling of the arms and the laser and phaco components to provide precise placement to the same position(s) these units were in prior to the switch. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In other words, if the system of Patton makes this switch within 8 minutes, one would simply need to increase the speed of the motors that cause the swiveling, so as to make this switch occur more rapidly to meet the claim of “less than 5 minutes”, which would be a matter of obviousness.
Regarding claim 62, Patton teaches an integrated reconfigurable laser-ultrasound system, comprising:
a. a therapeutic laser system (see Patton paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification), a phacoemulsification system (see Patton paragraph 7 - “e.g., a machine or system that can utilizes both a Femto laser and Phacoemulsification), a therapeutic laser beam path having a path length (as shown in Figure 16 of Patton, the laser components are within the housing of the device, whereas the laser beam exits the device at the furthest most end of the articulated arm, therefore it is obvious there is a beam path that extends up to the articulated arm and therethrough), a rigid laser beam delivery arm (see articulated arm 9 of Patton), and a housing (see housing 102 of Patton); the arm having a distal end and a proximal end and containing a portion of the therapeutic laser beam path , see paragraph 24 of Patton); wherein the distal end is optically associated with the therapeutic laser, and the proximal end is optically associated with a laser delivery head (see Figure 16 of Patton);
b. wherein the therapeutic laser is selected from the group consisting of a picosecond laser and a femtosecond laser (note the title, which states femto, implying a femtosecond laser).;
c. wherein the system has two predetermined configurations:
i. a first configuration for providing a therapeutic laser beam to a patient (see “Femto arrangement” in Figures 4 and 12-13 of Patton);
ii. a second configuration for performing a phacoemulsification procedure to the patient (see “Phaco arrangement” in Figures 14-15 of Patton); and,
d. wherein in the first configuration the laser delivery head is a first distance from the housing, and in the second configuration the laser delivery head is a second distance from the housing; wherein the first distance is different from the second distance (see Figures 4, 12 and 13 of Patton where laser delivery head is over the patient and a first distance from the housing, versus Figures 14-15 of Patton where laser delivery head resides atop the shorter cylindrical portion of the housing)
e. wherein the path length is the same for the first configuration and the second configuration (it is noted that the articulated arm does not compress, it simply swivels, therefore there would be no change to the path length); and,
f. whereby the integrated reconfigurable laser-ultrasound system provides for transitions between the first configuration and the second configuration (see paragraphs 7-8, 28, and 39 of Patton).
Regarding claims 64, it is noted that both the Patton references illustrate and teach articulated arms moving from a “stowed” position (i.e., not in use) to an extended position (i.e., in use). It is noted that there are multiple positions between these two positions, and especially with the system of the Patton references which swivel outward, this could be stopped at some position other than a full extension in order to align the device properly with a patient’s eye. In the case where less than a full extension of the swivel arm of the Patton references is used to provide laser treatment to a patient (e.g., in order to properly align the device), this would be considered a third configuration. That is, this would mean there is a stowed position, an “in use” position at which the arm is fully swiveled outward, and a second “in use” position in which the swivel arm is at some intermediate point between these other two positions in order to align the laser with the patient’s eye. This would read on “a third distance form the housing… [which] is different from the first/second distance”, the path length being the same since the arm does not change length but merely swivels, and the fact that the system would provide for transitions therebetween.
Regarding claim 69, it is noted that Patton teaches the system as described above with regard to the rejection of claims 30 and/or 62, in which it is described that this device is used in “performing a surgery”.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 1 above, and further in view of Friedman et al. (US Patent Pub. No. 2011/0196350).
Patton in combination with Patton’636 is described above with respect to claims 1-5 and 10-13. However, the Patton references do not explicitly teach the use of two lasers having different pulse durations.
Friedman teaches system for cataract surgery on an eye of a patient. In one embodiment, system for cataract surgery on an eye of a patient (see Abstract). “The first laser source may be configured to produce laser pulses having a first pulse duration between about 100 femtoseconds and about 10 picoseconds. The second laser source may be configured to produce laser pulses having a second pulse duration between about 10 picoseconds and about 10 nanoseconds. The controller may be configured to control the optical system to direct the first and second laser beams based upon a predetermined treatment pattern” (see paragraph 7). As stated in paragraph 10, the treatment pattern is followed by the controller in order to create a plurality of cuts in the lens (also see paragraph 69, among others throughout that mention cutting).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a dual beam system, as taught by Friedman, as a functional alternative to a single beam femtosecond laser system, such as that discussed by the Patton references, because Friedman explicitly states this by saying “The present invention can be implemented by a system that projects or scans an optical beam into a patient's eye 68, such as system 2 shown in FIG. 1 which includes an ultrafast (UF) light source 4 (e.g. a femtosecond laser, or a dual purpose system capable of emitting pulses in a lower and in a higher range of pulse energies, perhaps with different pulse durations.)” (see paragraph 34, emphasis added).
Claims 24-25, 27, 35, 37-38, 43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 1, 31 and 39 above, and further in view of Horvath et al. (US Patent Pub. No. 2016/0045367).
Patton in combination with Patton’636 is described above with respect to claims 1-5 and 10-13. However, the Patton references do not explicitly teach an iris registration system or an OCT system.
Horvath teaches a combined laser and phacoemulsification system for eye surgery, much in the same as is taught by the Patton references. “FIG. 27 illustrates a flow diagram of a possible laser eye surgery procedure of the here described laser system which in this version includes tracking and depth sensing capabilities. After the operator starts up the system, he/she performs a coarse alignment of the delivery system in the x-y- and z axis relative to the target location. An iris tracker or a video analysis system then locks on and holds the delivery system aligned to the target area. Furthermore, an Optical Coherence Tomography (OCT) or another depth sensing system measures and aligns the delivery system in the z-axis to the intended target depth plan of the eye. The operator sets a desired cutting diameter and then enables the treatment/cutting laser” (see paragraph 101, emphasis added).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize an iris tracking/registration system and an OCT system, as taught by Horvath, within the system and methods of Patton as combined with Patton’636 in order to align the system with the patient’s eye prior to delivering treatment, as such alignment is necessary and there are only so many features within the eye by which such a system would be aligned/registered that the use of iris tracking/registration and OCT to perform would amount to choosing from a finite number of alignment devices available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
Claims 26 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claim 25 above, and further in view of Papastathopoulos (DE 10 2011 116 368 A1).
Patton in combination with Patton’636 is described above with respect to claim 25. However, the Patton references do not explicitly teach the use of a Scheimpflug camera system.
Papastathopoulos teaches “a solution for the treatment of the human eye”, with a device that includes “an optical laser treatment unit with a corresponding control unit, wherein the optical laser treatment unit has a femtosecond laser. In addition, in the device, an ultrasonic treatment unit, a coupling element for coupling the respective energy of the successive treatment units used in the eye available” (see Abstract). Papastathopoulos states that “The guidance of the laser beam is carried out automatically by a pre-programmed scanning unit, wherein the exact coordinates of the cut on the basis of a, z. B. by means of an OCT method, a Scheimpflug camera or a confocal microscope…” (see page 3 of the machine translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize Scheimpflug camera system, as taught by Papastathopoulos, within the system and methods of Patton as combined with Patton’636 in order to align the system with the patient’s eye prior to delivering treatment (i.e., provide guidance), as such guidance is necessary and there are only so many known eye tracking methodologies used for this purpose, and to use of any particular one over another (i.e., an OCT method, a Scheimpflug camera or a confocal microscope, etc.) would amount to choosing from a finite number of guidance devices available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
Specifically regarding claim 29, it is noted that Papastathopoulos does not elaborate on any particular number of Scheimpflug cameras to be used. However, even if only a single camera is used (i.e., n=1), then this meets the claim, such that “”at least zero (0) cameras have an unobstructed view of an eye of a patient in any patient angle from 30 degrees to 320 degrees” is met by the reference.
Claims 34 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 31 and 39 above, and further in view of Bischoff et al. (DE 102011075734 A1).
Patton in combination with Patton’636 is described above with respect to claims 31 and 39. However, the Patton references teach swivel arms, rather than arms that pivot with the proximal end of the arm pivoted up in a second position, and horizontal in the first position.
Bischoff teaches a laser therapy device for treatment of the human eye (see Title) and it is taught that this laser therapy device has an adaptor to incorporate a phacoemulsification device, such that there is “means for transmitting electrical energy for the purpose of power supply and / or means for signal transmission between the laser therapy device and the coupled phacoemulsification device can be provided. The two devices can share operating and display elements in this way. In a specific embodiment, the phacoemulsification device may be a fully integrated component of the laser therapy device” (see page 3 of the machine translation). It can readily be seen in Figure 1 that the arm having the laser therapy means thereon pivots from an upright, vertical position down to a horizontal position for delivery of treatment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a vertical to horizontal pivoting motion, as taught by Bischoff, as a functional alternative to the swivel motion (i.e., pivoting outward versus pivoting upward) as taught by the Patton references, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claims 9, 22-23, 36, 44, 63 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 31 and 39 above, and further in view of Rathjen et al. (US Patent Pub. No. 2007/0010804).
Patton in combination with Patton’636 is described above with respect to claims 31 and 39. However, the Patton references fail to teach a scanner at a distal end of the arm.
Regarding claims 9, 36, 44 and 63, Rathjen teaches an ophthalmologic device for breaking down eye tissue (see Title). Figure 1 illustrates the system, which includes a light source 51 (noting that “It is possible to use light sources with high light pulse rates, for example femtosecond lasers”, see Abstract) and a scanner 52, which are both found within the base station 11 (see paragraph 30). After the scanner, a laser beam will pass a rotation element 54 before entering the articulated arm 13, from where it passes through the application head and the patient interface device 22.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a scanner in the base station near the distal end of the articulated arm, as taught by Rathjen, and to use this configuration within the system and methods of the Patton references in order to provide scanning of the laser across the eye.
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Regarding claims 22-23, it is first noted that in Figures 12-13 of Patton it shows the Femto-arrangement, in which the femtosecond laser is being used, which is also illustrated in Figure 8 as numeral 110. From these figures, it can be seen that this portion of the device extends outward from the second portion 30 of the device. As seen in Figure 15, it can be seen that cylindrical portion 30 is separated from the face of the patient (i.e., the eyes) by a distance at least equal to the length of the doctor’s forearm, if not longer. In this regard, it is noted that the claimed 300mm is equivalent to 11.8 inches, or just less than one foot. It is noted also that the length of an adult person’s forearm (i.e., from the back of the elbow to the wrist) is approximately one foot. Two lines of equal length with large dots at each end are shown below. These distances are shown to be approximately equal. It is noted, however, that this is simply the distance from the edge of the second portion 30 to about the position of the eye of the patient. This does not account for the fact that Figure 16 illustrates the components of the laser are contained further below within the housing, which will add additional length/distance between the laser to the patient’s eye, beyond that which is shown in the below figure, thereby meaning that this distance from the laser, through the articulated arm, to the patient’s eye would be greater than the approximate one foot that is explained above. For these reasons, this reads on “the laser beam path is longer than 300 mm”.
With regard go “the therapeutic laser system comprises an optics assembly for defining a laser beam path”, it is noted that in order for the laser to create and transmit light from within housing 30 to the eye of the patient, this will obviously require an optical pathway therebetween that includes optical elements making up an optical assembly. This is further evidenced by Figure 1 of Rathjen, which illustrates laser light traveling through an articulated arm 13 (see paragraph 11 of Rathjen). Furthermore, it is noted that mirrors within the articulated arm will not expand a laser beam pattern and would not present aberrations if/when the mirrors are clean, and a laser beam inherently does not spread/expand with greater distance.
Regarding claim 65, it is noted that both the Patton references illustrate and teach articulated arms moving from a “stowed” position (i.e., not in use) to an extended position (i.e., in use). It is noted that there are multiple positions between these two positions, and especially with the system of the Patton references which swivel outward, this could be stopped at some position other than a full extension in order to align the device properly with a patient’s eye. In the case where less than a full extension of the swivel arm of the Patton references is used to provide laser treatment to a patient (e.g., in order to properly align the device), this would be considered a third configuration. That is, this would mean there is a stowed position, an “in use” position at which the arm is fully swiveled outward, and a second “in use” position in which the swivel arm is at some intermediate point between these other two positions in order to align the laser with the patient’s eye. This would read on “a third distance form the housing… [which] is different from the first/second distance”, the path length being the same since the arm does not change length but merely swivels, and the fact that the system would provide for transitions therebetween.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Patton in view of Patton’636 as applied to claims 31 and 39 above, and further in view of Takahashi et al. (EP 0208175 A2).
Patton in combination with Patton’636 is described above with respect to claims 31 and 39. However, the Patton references fail to teach a closing means at the therapeutic end of the light path.
Takahashi teaches “a light transmission apparatus in which light from a laser is transmitting through a fiber optic” (see Abstract). More specifically, Takahashi teaches the following on page 3:
Conventionally, an opening/closing cover has been provided at the light-emitting end of an optical fiber to prevent such accidents. The cover is opened only when a laser beam is emitted and closed when no laser beam is being emitted. Thus, the light-emitting end of the optical fiber is protected by the cover when no laser beam is emitted. However, the laser beam per se has no power to prevent dust, blood, drops of water, or the like, from adhering onto the light-emitting end. When the light-emitting end of the optical fiber is put in an environment containing liquid, such as water drops, blood, or the like, the liquid may adhere to the light-emitting end when the protecting cover is opened during emission. This deteriorates the transmittivity at the end surface to extremely reduce the treating capability of the laser beam. Further, the light-emitting end may be sometimes broken because the end surface is sharply heated. There are two kinds of opening/closing mechanisms, one being of the type provided at the forward end of an optical fiber and the other being of the type provided in the back of an optical fiber and controlled remotely.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a cover over the therapeutic end of the light transmission pathway in order protect the end when the laser beam is not in use, as taught by Takahashi, and to utilize this in the system of the Patton references, to provide that “the cover is opened only when a laser beam is emitted and closed when no laser beam is being emitted. Thus, the light-emitting end of the optical fiber is protected by the cover when no laser beam is emitted” (see quote from Takahashi above).
Conclusion
Additional prior art is made of record as considered pertinent to applicant's disclosure, but not relied upon in the rejections above, and may be found listed in the PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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