DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 44 and 62-67 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 44, it is unclear what constitutes a state indication (i.e.: fully open, fully closed, partially open, partially closed, etc) and therefore there can be an infinite amount of indications.
Regarding Claim 62, it is unclear how the instrument host is configured to start a surgical procedure with the known volume of irrigation fluid in the fluid source; administer irrigation fluid; start a timer; calculate an accumulated irrigation flow rate; stop the administering of irrigation fluid and the timer; acquire a total elapsed time; and calculate a total amount of irrigation fluid used during the surgical procedure. Examiner interprets that the instrument host is configured to send a set of instructions that allow the system to perform these actions.
All remaining claims are rejected by virtue of their dependence on claim 62.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 56-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dam-Huisman (Pub. No. US 20200360594 A1).
Regarding Claim 56, Dam-Huisman discloses a method for monitoring the amount of fluid used or remaining in a fluid source (210) during an ophthalmic surgical procedure (Abstract, Paragraph [0035]), comprising:
starting a surgical procedure with a known volume of an irrigation fluid in a fluid source (“Under the direction of the controller 40, the irrigation pump 212 moves the fluid F from the (infusion) fluid source 210” – Paragraph [0023]; Examiner interprets this action as beginning the surgical procedure);
administering the irrigation fluid (“By pressurising the chamber 10, irrigation fluid F can be delivered to the eye 1 at a pressure determined by a medical practitioner” – Paragraph [0026]);
starting a timer (Examiner interprets that once the procedure begins, the system may begin a timer. Examiner recognizes that the act of starting a timer can be considered a mental process);
calculating an accumulated irrigation flow rate (“The controller is configured to calculate the irrigation flow through the irrigation tip based on the fluid level measured by the fluid level indicator 50 and/or the infusion rate determined by the velocity controller 220” – Paragraph [0032]);
stopping the administering of irrigation fluid and the timer (Examiner interprets that once administration of the fluid has ceased, the procedure and timer stop);
acquiring a total elapsed time (total time can be determined from comparing the start time to end time); and
calculating a total amount of irrigation fluid used during the surgical procedure (“The extracted volume can be calculated based on the initial quantity of irrigation fluid in the infusion bottle 210 and the amount of the fluid delivered to the chamber 10 by the velocity controller 220” – Paragraph [0035])
Examiner interprets this method step is able to be performed as a mental process.
Regarding Claim 57, Dam-Huisman discloses the method of claim 56, wherein the accumulated irrigation flow is a sum of a positive irrigation and negative irrigation (Paragraphs [0061], [0070]; controller 40 is able to adjust valve arrangement 25 to adjust pressure from the positive 24 and negative 22 pressure sources to determine an overall irrigation flow).
Regarding Claim 58, Dam-Huisman discloses the method of claim 56, wherein the amount of irrigation fluid used during the surgical procedure is determined by the following formula:
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Solution used can be determined by taking the accumulated flow acquired from controller 40 and dividing it by total number of measurements taken from controller 40, multiplying by the total time of the procedure acquired from the start and end time, then dividing by 60.
Regarding Claim 59, Dam-Huisman discloses the method of claim 56, wherein the known volume of irrigation fluid is carried over from a previous surgical procedure (Examiner interprets that the procedure begins from the administration of the irrigation fluid and ends when administration of the irrigation fluid ceases, therefore once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume from the irrigation source from the calculation step in claim 56 and taking the difference from the initial fluid source volume to determine remaining volume within the fluid source).
Regarding Claim 61, Dam-Huisman discloses the method of claim 56, further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value (Paragraph [0035]).
Regarding Claim 62, Dam-Huisman discloses a system for monitoring the amount of fluid used during an ophthalmic surgical procedure (200, Abstract, Paragraph [0035]), comprising:
a fluid source (210) coupled with a surgical console (Paragraph [0022]) having a known volume of irrigation fluid (Fig. 1, Paragraph [0028]);
an irrigation pump (212) fluidly coupled with the fluid source (Paragraph [0020]) and in communication with an encoder (220) for tracking the activation time of the irrigation pump (Paragraph [0035], Fig. 2); and
an instrument host (40) configured to:
start a surgical procedure with the known volume of irrigation fluid in the fluid source (“Under the direction of the controller 40, the irrigation pump 212 moves the fluid F from the (infusion) fluid source 210” – Paragraph [0023]; Examiner interprets this action as beginning the surgical procedure);
administer irrigation fluid (“By pressurising the chamber 10, irrigation fluid F can be delivered to the eye 1 at a pressure determined by a medical practitioner” – Paragraph [0026]);
start a timer (Examiner interprets this method step is able to be performed as a mental process.);
calculate an accumulated irrigation flow rate (“The controller is configured to calculate the irrigation flow through the irrigation tip based on the fluid level measured by the fluid level indicator 50 and/or the infusion rate determined by the velocity controller 220” – Paragraph [0032]);
stop the administering of irrigation fluid and the timer (Examiner interprets that once administration of the fluid has ceased, the procedure and timer stop);
acquire a total elapsed time (total time can be determined from comparing the start time to end time); and
calculate a total amount of irrigation fluid used during the surgical procedure (“The extracted volume can be calculated based on the initial quantity of irrigation fluid in the infusion bottle 210 and the amount of the fluid delivered to the chamber 10 by the velocity controller 220” – Paragraph [0035]) Examiner interprets this step is able to be performed as a mental process.
Regarding Claim 63, Dam-Huisman discloses the system of claim 62, wherein the accumulated irrigation flow is a sum of a positive irrigation and negative irrigation (Paragraphs [0061], [0070]; controller 40 is able to adjust valve arrangement 25 to adjust pressure from the positive 24 and negative 22 pressure sources to determine an overall irrigation flow).
Regarding Claim 64, The system of claim 62, wherein the amount of irrigation fluid used during the surgical procedure is determined by the following formula:
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589
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Solution used can be determined by taking the accumulated flow acquired from controller 40 and dividing it by total number of measurements taken from controller 40, multiplying by the total time of the procedure acquired from the start and end time, then dividing by 60.
Regarding Claim 65, Dam-Huisman discloses the system of claim 62, wherein the known volume of irrigation fluid is carried over from a previous surgical procedure (Examiner interprets that the procedure begins from the administration of the irrigation fluid and ends when administration of the irrigation fluid ceases, therefore once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume from the irrigation source from the calculation step in claim 62 and taking the difference from the initial fluid source volume to determine remaining volume within the fluid source).
Regarding Claim 67, Dam-Huisman discloses the system of claim 62, further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value (Paragraph [0035]).
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.
Claim(s) 44-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (Pub. No. US 20190099547 A1, herein, Mehta) in view of Dam-Huisman (Pub. No. US 20200360594 A1).
Regarding Claim 44, Mehta discloses a method for monitoring the amount of fluid used during an ophthalmic surgical procedure (Abstract, Fig. 8), comprising:
inputting into a surgical console (850) the volume of a fluid source in communication with the surgical console (Paragraph [0021]);
attaching to the surgical console a cassette having a known fluid capacity (“fluid pack 855 may be in the form of a cassette which may be removably attached to surgical console 850” – Para [0128]);
receiving by the surgical console an encoder value for tracking the use of at least one pump (“The system may use a pump (e.g. a flow based (peristaltic) or vacuum based (Venturi) pump) to transfer fluid from the BSS container to the pressurized infusion tank inside the fluidics pack 855, as illustrated in FIG. 8. The present invention, via the console 850, for example, may track the starting and ending encoder counts to determine the amount of fluid transferred to the tank” – Paragraph [0120]).
Mehta does not expressly disclose a plurality of state indications of an irrigation valve control; and calculating the amount of fluid removed from the fluid source by summing the plurality of state indications and the fluid capacity of the cassette.
Dam-Huisman discloses a plurality of state indications of an irrigation valve control (25, Paragraph [0058]); and
calculating the amount of fluid removed from the fluid source by summing the plurality of state indications (“The extracted volume can be calculated based on the initial quantity of irrigation fluid in the infusion bottle 210 and the amount of the fluid delivered to the chamber 10 by the velocity controller 220” – Paragraph [0035) and the fluid capacity of the cassette (Paragraph [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method for monitoring the amount of fluid used during an ophthalmic surgical procedure as disclosed by Mehta with a plurality of state indications of an irrigation valve control; and calculating the amount of fluid removed from the fluid source by summing the plurality of state indications and the fluid capacity of the cassette as taught by Dam-Huisman in order to maintain pressure and flow within the cassette during the ophthalmic procedure (Dam-Huisman, Paragraph [0026]).
Regarding Claim 45, Dam-Huisman discloses the method of claim 44, wherein each state indication is indicative of an open or closed valve position (“the first and second adjustable/proportional valves R1, R2 are position controlled valves” – Paragraph [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method for monitoring the amount of fluid used during an ophthalmic surgical procedure as disclosed by Mehta wherein each state indication is indicative of an open or closed valve position as taught by Dam-Huisman so that pressure applied to the cassette is variable (Dam-Huisman, Paragraph [0025]).
Regarding Claim 46, Mehta discloses the method of claim 44, wherein the encoder (830) tracks activity of a drainage pump that is in communication with the cassette (“the intraoperative pressure management algorithm may measure the difference between sensor 861 and sensor 860 along the aspiration fluid path to calculate actual aspiration flow rate in real-time. This method may be used for both Peristaltic and Venturi based aspiration.” – Paragraph [0102]).
Regarding Claim 47, Mehta discloses the method of claim 46 wherein the activity of the drainage pump is selected from the group consisting of pump runtime and pump speed (“the intraoperative pressure management algorithm may measure the difference between sensor 861 and sensor 860 along the aspiration fluid path to calculate actual aspiration flow rate in real-time. This method may be used for both Peristaltic and Venturi based aspiration.” – Paragraph [0102], the rate in which the aspiration flow is measured is interpreted to be some measurement of time i.e. mL/sec, which accounts for both pump speed and runtime).
Regarding Claim 48, Mehta discloses the method of claim 46, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with the encoder tracked activity of the drainage pump (“the intraoperative pressure management algorithm may measure the difference between sensor 861 and sensor 860 along the aspiration fluid path to calculate actual aspiration flow rate in real-time. This method may be used for both Peristaltic and Venturi based aspiration.” – Paragraph [0102], examiner interprets that the amount of fluid removed may be calculated by taking the aspiration flow rate and multiplying it by the elapsed time of the procedure to acquire an amount of fluid removed).
Regarding Claim 49, Mehta discloses the method of claim 44, wherein the encoder tracks activity of an irrigation pump that is in communication with the cassette (“the intraoperative pressure management algorithm, which may be resident in surgical console 850 … may continuously measure and adjust the irrigation pressure of system through the IOP management controller 930 … The TOP management controller 930 may control the pump 810” – Paragraph [0095], Fig. 9A).
Regarding Claim 50, Mehta discloses the method of claim 49, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with the encoder tracked activity of the irrigation pump (Paragraph [0120]).
Regarding Claim 51, Mehta discloses the method of claim 44, wherein the calculating the amount of fluid removed from the fluid source further includes summing the amount of fluid associated with wound leakage (Paragraph [0091], providers are able to account for wound leakage via sensor 861 and calculate fluid removed accordingly).
Regarding Claim 52, Mehta discloses the method of claim 44, wherein the fluid capacity of the cassette includes a handpiece volume (“the irrigation source 30 is configured to supply a predetermined amount of fluid to the handpiece 20 for use during a surgical operation” – Paragraph [0044]) and an aspiration and irrigation tubing (Aspiration Line and Irrigation Line, respectively in Fig. 8).
Regarding Claim 53, Mehta discloses the method of claim 44, wherein the volume of the fluid source is an initial size of the fluid source (“the irrigation source 30 is configured to supply a predetermined amount of fluid” – Paragraph [0044]) coupled with the surgical console (“surgical console 850 may be in communication with irrigation source 30” – Paragraph [0090]).
Regarding Claim 54, modified Mehta in view of Dam-Huisman discloses wherein the volume of the fluid source is carried over from a previous ophthalmic surgical procedure (Examiner interprets that the procedure begins from the administration of the irrigation fluid and ends when administration of the irrigation fluid ceases, therefore once irrigation flow begins to initiate a second procedure, users are able to determine remaining volume from the irrigation source from the calculation step in claim 44 and taking the difference from the initial fluid source volume to determine remaining volume within the fluid source).
Regarding Claim 55, modified Mehta in view of Dam-Huisman discloses the method of claim 44, further comprising providing a warning when the amount of fluid remaining in the fluid source drops below a threshold value (Dam-Huisman, Paragraph [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method for monitoring the amount of fluid used during an ophthalmic surgical procedure as disclosed by Mehta so that it provides a warning when the amount of fluid remaining in the fluid source drops below a threshold value as taught by Dam-Huisman in order to determine when a volume of irrigated fluid has been delivered (Dam-Huisman, Paragraph [0036]).
Claim(s) 60 and 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dam-Huisman in view of Mehta et al. (Pub. No. US 20190099547 A1, herein, Mehta).
Regarding Claim 60, Dam-Huisman discloses the method of claim 56.
Dam-Huisman does not expressly disclose wherein the known volume of irrigation fluid is inputted by a user.
Mehta teaches wherein the known volume of irrigation fluid is inputted by a user (“a graphical user interface capable of receiving input from a user on a starting volume of BSS in the BSS container” – Paragraph [0021].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method for monitoring the amount of fluid used during an ophthalmic surgical procedure as disclosed by Dam-Huisman so that the known volume of irrigation fluid is inputted by a user as taught by Mehta in order to determine the amount of fluid transferred from the irrigation source to an infusion tank (Paragraph [0021]).
Regarding Claim 66, Dam-Huisman discloses the system of claim 62.
Dam-Huisman does not expressly disclose wherein the known volume of irrigation fluid is inputted by a user.
Mehta teaches wherein the known volume of irrigation fluid is inputted by a user (“a graphical user interface capable of receiving input from a user on a starting volume of BSS in the BSS container” – Paragraph [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method for monitoring the amount of fluid used during an ophthalmic surgical procedure as disclosed by Dam-Huisman so that the known volume of irrigation fluid is inputted by a user as taught by Mehta in order to determine the amount of fluid transferred from the irrigation source to an infusion tank (Paragraph [0021]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783