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.
Claims 1-14 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 recites the limitation, “predetermined accuracy” without providing a description as to the what may constitute said “predetermined” value (i.e., no description of a working range is provided in the claims or specification). When the metes and bounds of a claimed range or value are not clearly set forth, the claim is rendered indefinite (see MPEP 2173.05(c)).
Claims 2-14 are also rendered indefinite due to their dependency from and further modification of indefinite claim 1.
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.
Claim(s) 1 and 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 2016/0106461 A1) in view of Azevedo (US 2016/0287241 A1).
Regarding claim 1, Morris discloses:
A surgical port device (cannula 2, see Fig. 1) for insertion into the scleral wall during intraocular surgery (see Fig. 1 and Para. [0026]), the device comprising:
a body (body of cannula 2, see Fig. 1).
However, Morris does not expressly disclose:
at least one sensor;
wherein the at least one sensor is operatively associated with the body, either integrated within the body or attached thereto; and
a communication module integrated within the body or attached thereto, capable of transmitting data generated by the at least one sensor to an external receiver via wireless or wired transmission methods.
In the same field of endeavor, namely surgical access devices configured to act as and provide an entry port for additional surgical instruments to an intended surgical site, Azevedo teaches:
A surgical port device (measurement ring 10, see Fig. 1 and Para. [0015]) for insertion into a bodily cavity during a surgical procedure (see Para. [0015]-[0016]), the device comprising:
a body (body of measurement ring 10, see Fig. 1).
at least one sensor (sensor(s) 18, see Fig. 1);
wherein the at least one sensor is operatively associated with the body, either integrated within the body or attached thereto (see Fig. 1 showing wherein sensor(s) 18 are integrated into the structure of the measurement ring 10; see also Para. [0019]) to measure any of: Insertion of an instrument within the insertion channel of the measurement ring, position and/or pressure applied by the instrument against the hollow channel of the measurement ring, speed of insertion of the instrument in the insertion channel, pressure of the instrument on the interior of the hollow channel or portion thereof, and pressure of the instrument on the annular lip or portion thereof (see Para. [0018]); and
a communication module (communication module 20, see Fig. 1) integrated within the body or attached thereto (see Fig. 1 showing wherein communication module is integrated into the structure of the measurement ring 10; see also Para. [0023]), capable of transmitting data generated by the at least one sensor to an external receiver via wireless or wired transmission methods (see Para. [0023], [0029] and [0034]-[0035] mentioning wherein communication module 20 sends data received from sensor(s 18 wirelessly (or through a physical connection) to an external display 150 of monitoring apparatus 100) to provide a user with a visual representation of the target surgical site and location of the surgical instrument within said target site (see Para. [0034]-[0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the cannula of Morris to include at least one sensor therein configured to receive and track various parameters of the cannula and/or instrument positioned therein including: Insertion of an instrument within the insertion channel of the cannula, position and/or pressure applied by the instrument against the hollow channel of the cannula, speed of insertion of the instrument in the insertion channel of the cannula, pressure of the instrument on the interior of the hollow channel or portion thereof, and/or pressure of the instrument on the annular lip or portion thereof (see Azevedo Para. [0018]). It would have further been obvious to one of ordinary skill in the art to have included a communication module within the device of Morris, as taught and suggested by Azevedo, to send data generated from said sensors at the surgical site to an external display so as to generate and provide a user with an image of the target site and/or location of the surgical device(s) within the target site (see Azevedo Para. [0034]-[0035]).
Regarding claim 6, the combination of Morris and Azevedo disclose the invention of claim 1, Morris, as modified by Azevedo, further discloses wherein the communication module is capable of both wireless and wired data transmission (see Azevedo Para. [0029]-[0030] mentioning wherein the communication module, as incorporated into the device of Morris, is configured to communicate with the monitoring apparatus via either a wireless or physical connection; a “physical connection” is understood to refer to a physical electrical connection which is a wire).
Regarding claim 7, the combination of Morris and Azevedo disclose the invention of claim 1, Morris, as modified by Azevedo, further discloses a data processing unit (processor 134, see Azevedo Para. [0031]) operatively connected to the at least one sensor for processing data (see Azevedo Para. [0029]-[0031] and [0034]-[0035]), capable of interfacing with both wireless and wired communication modules (see Azevedo Para. [0029]-[0030] mentioning wherein the processor 134 of a monitoring engine 130 is connected to communication unit 120 which may communicate with communication module 20 either wirelessly or through a physical connection; a “physical connection” is understood to refer to a physical electrical connection which is a wire).
Regarding claim 8, the combination of Morris and Azevedo disclose the invention of claim 7, Morris, as modified by Azevedo, further discloses wherein the data processing unit is configured to generate real-time feedback based on the processed data (see Azevedo Para. [0034] mentioning wherein the processor(s) 134 provide guidelines or information for improving the performance of the medical professional during the procedure on display 150 during a given surgical procedure).
Regarding claim 9, the combination of Morris and Azevedo disclose the invention of claim 8, Morris, as modified by Azevedo, further discloses wherein the real-time feedback includes visual, auditory, or haptic feedback (see Para. [0034] mentioning wherein the feedback to the user is provided visually on display 150).
Regarding claim 10, the combination of Morris and Azevedo disclose the invention of claim 1, Morris, as modified by Azevedo, further discloses an augmented reality interface that receives data from the communication module and displays augmented reality visualizations based on the data (see Azevedo Para. [0034]-[0035] mentioning wherein data from sensor(s) 18 is communicated to a display 150 through communication module 20 to be displayed as an augmented reality image), adaptable to receive data via both wireless and wired transmissions (see Para. [0029]-[0030] mentioning wherein communication module 20 may communicate with wirelessly or through a physical connection; a “physical connection” is understood to refer to a physical electrical connection which is a wire).
Regarding claim 11, the combination of Morris and Azevedo disclose the invention of claim 10, Morris, as modified by Azevedo, further discloses wherein the augmented reality visualizations provide a representation of surgical instruments relative to intraocular structures (see Azevedo Para. [0018] and [0035] mentioning wherein sensor(s) 18 may track the position of surgical instruments disposed within the channel of the measurement ring/cannula to be sent to the display 150 for augmented reality visualization of the surgical site).
Regarding claim 12, the combination of Morris and Azevedo disclose the invention of claim 1, Morris further discloses wherein the body is cylindrical and sized to facilitate insertion into the scleral wall without significant tissue damage. (see Morris Para. [0010] and [0026]).
Regarding claim 13, the combination of Morris and Azevedo disclose the invention of claim 1, Morris further discloses wherein the device is configured to operate continuously throughout the duration of the surgical procedure (device of Morris operates continuously until removed from the scleral wall within the eye of a patient; see also Azevedo Para. [0022] mentioning wherein sensor(s) 18 operate continuously during a procedure).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 2016/0106461 A1) in view of Azevedo (US 2016/0287241 A1), further in view of Harris (US 2021/0338371 A1).
Regarding claim 2, the combination of Morris and Azevedo disclose all of the limitations of the invention of claim 1.
However, none of either Morris or Azevedo expressly disclose wherein the one or more sensors include an accelerometer.
In the same field of endeavor, namely surgical insertion ports/cannulas, Harris teaches wherein a surgical entry cannula (cannula assembly 112, see Fig. 6) may comprise a gyroscopic sensor (see Para. [0074]) thereon to help a user maintain a specific angular orientation of the cannula assembly relative to a patient when a surgeon has released cannula assembly from his or her grasp or control, thus enabling the surgeon to safely perform other surgical tasks without having to manually maintain or otherwise monitor the angular orientation of cannula assembly (see Para. [0074]); and wherein the cannula device may further comprise an accelerometer for sensing the linear acceleration of the gyroscope device (see Para. [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a gyroscopic sensor element into the cannula of Morris to, in this case, help a user maintain a specific angular orientation of the cannula assembly relative to a patient when a surgeon has released cannula assembly from his or her grasp or control, thus enabling the surgeon to safely perform other surgical tasks without having to manually maintain or otherwise monitor the angular orientation of cannula assembly (see Harris Para. [0074]). It would have further been obvious to one of ordinary skill in the art to have included an accompanying accelerometer into the canula device of Morris, as modified by Harris, to sense and track the linear acceleration of the gyroscope element (see Harris Para. [0099]).
Regarding claim 3, the combination of Morris and Azevedo disclose all of the limitations of the invention of claim 1.
However, none of either Morris or Azevedo expressly disclose a gyroscope as part of the sensor array.
In the same field of endeavor, namely surgical insertion ports/cannulas, Harris teaches wherein a surgical entry cannula (cannula assembly 112, see Fig. 6) may comprise a gyroscopic sensor (see Para. [0074]) thereon to help a user maintain a specific angular orientation of the cannula assembly relative to a patient when a surgeon has released cannula assembly from his or her grasp or control, thus enabling the surgeon to safely perform other surgical tasks without having to manually maintain or otherwise monitor the angular orientation of cannula assembly (see Para. [0074]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included a gyroscopic sensor element into the cannula of Morris to, in this case, help a user maintain a specific angular orientation of the cannula assembly relative to a patient when a surgeon has released cannula assembly from his or her grasp or control, thus enabling the surgeon to safely perform other surgical tasks without having to manually maintain or otherwise monitor the angular orientation of cannula assembly (see Harris Para. [0074]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 2016/0106461 A1) in view of Azevedo (US 2016/0287241 A1), further in view of Richter (US 2019/0209154 A1).
Regarding claim 4, the combination of Morris and Azevedo disclose all of the limitations of the invention of claim 1.
However, none of either Morris or Azevedo expressly disclose a magnetometer as part of the sensor array.
In the same field of endeavor, namely surgical port access devices comprising one or more sensors disposed therein to track position and/or orientation information of the device, Richter teaches wherein an entry port system (see Fig. 1A) comprises a navigation array (708, see Para. [0034]) which may include a magnetometer, an accelerometer, a gyroscope or other sensors (see Para. [0339]) to transmit position and/or orientation information of the entry port device to the navigation system to enable a user to track said position and/or orientation of the device during use.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the sensor array of Morris, as incorporated from the teachings of Azevedo, to include a magnetometer as taught and suggested by Richter for the purpose of, in this case helping to track the position and/or orientation of the cannula device during operation (see Richter Para. [0339]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 2016/0106461 A1) in view of Azevedo (US 2016/0287241 A1), further in view of Trimarche (US 2022/0039788 A1).
Regarding claim 1, the combination of Morris and Azevedo disclose all of the limitations of the invention of claim 1.
However, none of either Morris or Azevedo expressly disclose wherein the at least one sensor further includes an infrared sensor.
In the same field of endeavor, namely surgical access port devices, Trimarche teaches wherein a surgical access port device (see Fig. 1) may comprise an infrared sensor attached thereto (sensor 410, see Para. [0029]) which provides data to a monitoring/navigation system to provide a magnetic resonance image (MRI) of the surgical site during use (see Para. [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the sensor array of Azevedo, as incorporated into the device of Morris, to include an infrared sensor as taught and suggested by Trimarche for the purpose of generating imaging data to be sent to the monitoring/navigation system to provide a user with an MRI image of the target surgical site (see Trimarche Para. [0029]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 2016/0106461 A1) in view of Azevedo (US 2016/0287241 A1), further in view of Fehr (US 2021/0137379 A1).
Regarding claim 14, the combination of Morris and Azevedo disclose all of the limitations of the invention of claim 1.
However, none of either Morris or Azevedo expressly disclose wherein the at least one sensor is encapsulated within a biocompatible material that is compliant with medical standards for intraocular use.
In the same field of endeavor, namely sensor devices configured for use within a patient’s eye, Fehr teaches an ocular implant (IOL 12, see Fig. 3A) comprising a sensor disposed therein (sensor assembly 14, see Fig. 3A and Para. [0065]-[0066]), wherein the sensor should be encapsulated in a biocompatible coating to act as a barrier between the sensor and surrounding tissue (see Para. [0012] and [0082]); said sensor is coating with a silicone gel which is then encapsulated in a flexible, biocompatible multilayer coating consisting of alternating layers of Parylene C and SiO (see Para. [0012] and [0075]) to provide a barrier between the sensor and the surrounding tissue while maintaining the senor’s ability to function properly (see Para. [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Morris, as modified by Fehr, to include a silica gel coating onto each of the sensor elements before then encapsulating the sensor elements in an alternating layer of biocompatible Parylene C and SiO as taught and suggested by Fehr to, in this case, provide a barrier between the sensor element and the surround ocular tissue while maintaining normal functionality of the sensor elements (see Fehr Para. [0012], [0075] and [0072]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20060189898 A1 to Nitzan, US 20220095963 A1 to Bao, US 20250143640 A1 to Fu, US 20170000980 A1 to Potosky, US 2025/0104229 A1 to Hallen, US 20240341806 A1 to Norton, US 20160296221 A1 to Morris, US 20210196314 A1 to Govari and US 20170143435 A1 to Scholan all disclose surgical entry port devices comprising a sensor configured to measure a specific location/orientation parameter of the surgical entry port or instrument inserted therein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771