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 .
Response to Arguments
The previous objection of claims 1, 11, 16 and 18 due to minor informalities has been withdrawn in light of applicant’s amendments made 12/02/2025.
The rejection of claims 1, 11, 16 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Prior et al. (US 2021/0275257 A1) has been withdrawn in light of applicant’s amendment made 3/24/2025. Specifically, Prior does not teach a first plurality of sensors along the length of the sleeve and a second plurality of sensors along the length of the shaft.
Applicant’s arguments with respect to claims 1, 11, 16 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, Skalyni (US 2013/0206147 A1) teaches said limitation. It is noted applicant has not argued the prior art combination of Prior in view of Skalyni, just that claim 2 has been withdrawn [canceled] and claims 3 and 4 now depend from independent claim 1. Accordingly, rejections over Prior in view of Skalyni have been maintained.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the length of the sleeve” in line 7 which should read “a length of the sleeve”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the first plurality of sensors are” in lines 7-8 which should read “the first plurality of sensors is” for grammatical purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the length of the shaft” in line 11 which should read “a length of the shaft”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the second plurality of sensors are” in lines 11-12 which should read “the second plurality of sensors is”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Claim 3 recites “a length of the shaft” in lines 2-3 which should read “the length of the shaft”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 recites “the second sensor array includes a plurality of sleeve sensors longitudinally spaced apart from each other along an outer surface of the sleeve”. As best understood by the claims and the specification, the second sensor array comprises the second plurality of sensors which is along the length of the shaft. The specification does not provide support for the second plurality of sensors to be both along the shaft and the sleeve. Instead, the first plurality of sensors is along the sleeve and the second plurality of sensors is along the shaft. For the purposes of examination, the limitation has been interpreted to read “a first sensor array includes the first plurality of sensors”.
Claim 10 recites “the second plurality of sensors includes an optical sensor secured to the sleeve”. Claim 10 depends from claim 1 which recites “a second plurality of sensors along the length of the shaft” in line 11. The specification does not provide support for the second plurality of sensors to be both along the shaft and the sleeve. Instead, the first plurality of sensors is along the sleeve and the second plurality of sensors is along the shaft.
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 3-6 and 13 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 3 recites the limitation "the second sensor array" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “a plurality of shaft sensors” in line 3. Claim 3 depends from claim 1 which recites “a second plurality of sensors along the length of the shaft” in line 11. It is unclear if the plurality of shaft sensors of claim 3 is intended to be the same or in addition to the second plurality of sensors along the length of the shaft of claim 1. For the purposes of examination, the plurality of shaft sensors is interpreted to be the same as the second plurality of sensors.
Claim 4 recites the limitation "the second sensor array" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “a plurality of sleeve sensors” in line 2. Claim 4 depends from claim 1 which recites “a first plurality of sensors along the length of the sleeve” in line 7. It is unclear if the plurality of sleeve sensors of claim 4 is intended to be the same or in addition to the first plurality of sensors along the length of the sleeve of claim 1. For the purposes of examination, the plurality of sleeve sensors is interpreted to be the same as the first plurality of sensors.
Claim 5 recites the limitation "the second sensor array" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the first sensory array" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the plurality of sensors” in line 1. There is insufficient antecedent basis for this limitation in the claim as it is unclear if this refers to the first and/or second plurality of sensors or sensors in addition thereto.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2021/0275257 A1) in view of Skalyni (US 2013/0206147 A1).
Regarding claims 1 and 3-4, Prior discloses an apparatus (uterine manipulator 100), comprising: (a) a base portion (housing 110) configured to selectively couple with a robotic arm (housing 110 may be secured to a robotic arm 902, 903 for robotic operation via attaching device 909, 911; [0038]; [0057]; Fig. 9); (b) a shaft (shaft 120) extending distally form the base portion (110; Fig. 1) and terminating into a distal end (towards 190; Fig. 1); (c) a sleeve (slidable occluder shaft 130 and shuttle 150) slidably coupled to the shaft (Fig. 1; [0038]); (d) a colpotomy cup (cervical cup 160) fixedly secured to a portion of the sleeve (via shuttle 150; Fig. 1); and (e) a first plurality of sensors (position sensors 161, 162 and/or 163), wherein the sensors are configured to locate a position of the sleeve relative to one or more anatomical features of a patient (as the sensors are positioned on the cup 160 which is fixedly attached to the sleeve and the sensors may be used to identify a location of any element of the UM along with the patient’s anatomy in real-time; [0033]; [0040]) by sensing contact with the patient (as at least one magnet 162 can be used to confirm that the cervical cup 160 is engaged with the patient’s cervix; [0041]; and/or vibrating element 163 can be used to confirm that the cervical cup 160 is in contact with a ureter of the patient to determine a location of the cervical cup 160; [0042]), and a second plurality of sensors (others of multiple position sensors 161; [0040]), wherein the second plurality of sensors are configured to locate the position of the sleeve relative to the shaft (as the sensors may be used to identify a location of any element of the UM i.e. the sleeve and shaft; [0033]).
Prior discloses the plurality of sensors (multiple sensors 161) may be arranged at various locations about the colpotomy cup (160; [0040]) including at proximal end of the colpotomy cup and a distal end of the colpotomy cup i.e. longitudinally spaced apart from each other along a length of the cup ([0040]), but fails to explicitly disclose wherein the plurality of sensors define a first plurality of sensors/first sensor array along the length of the sleeve longitudinally spaced apart from each other along an outer surface of the sleeve to sense contact with the patient along the length of the sleeve, and a second plurality of sensors/second sensor array along a length of the shaft longitudinally spaced apart from each other along the length of the shaft to sensing the presence of the sleeve along the length of the shaft.
However, Skalyni teaches a uterine apparatus comprising a shaft (shaft 560; Figs. 15A-16), a sleeve (seal assembly 500; Figs. 14A-14B) slidably coupled to the shaft (as the shaft 560 is slid within the seal assembly 500), and a plurality of sensors i.e. an array (position sensors; [0091]) on the shaft and the sleeve ([0091]), wherein the position sensors are configured to locate a position of the sleeve relative to one or more anatomical features of a patient along the length of the sleeve and shaft (i.e., the patients endocervical canal and uterine cavity; [0091]), wherein the plurality of sensors are further configured to locate a position of the sleeve relative to the shaft by sensing the presence of the sleeve along the length of the shaft (as the position sensors determine the axial relationship between the sleeves; [0091]). The plurality of position sensors on the shaft and the sleeve are for determining the axial relationship between the shaft and the sleeve to determine proper deployment of the apparatus relative to a patients endocervical canal and uterine cavity ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of sensors of Prior to be positioned in a first sensor array including a plurality of shaft sensors longitudinally spaced apart from each other along a length of an outer surface of the sleeve by sensing contact with the patient along the length of the sleeve and a second sensor array including a plurality of shaft sensors longitudinally spaced apart from each other along the shaft by sensing the presence of the sleeve along the length of the shaft in light of the teachings of Prior and Skalyni in order to better determine the axial relationship between the shaft and the sleeve to determine proper deployment of the apparatus. Further, all the claimed elements were known in the prior art (plurality of position sensors being placed on a shaft, a sleeve, and a plurality of position sensors being spaced apart longitudinally) 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 would have yielded the predictable result of being able to track the position of the apparatus.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2021/0275257 A1) in view of Skalyni (US 2013/0206147 A1), as applied to claim 1 above, and further in view of Narkiss et al. (US 2019/0076100 A1).
Regarding claims 5-6, modified Prior discloses wherein the second sensor array (sensors on the shaft of modified Prior) is configured to detect the position of the sleeve relative to the shaft (as the sensors of Prior may be used to identify a location of any element of the UM i.e., the sleeve and shaft; [0033]; and the position sensors of Skalyni determine the axial relationship between the sleeves; [0091]) and wherein the first sensor array (sensors on the sleeve of modified Prior) is configured to sense a presence of tissue (as the sensors of Prior may be used to identify a location of any element of the UM along with the patient’s anatomy in real-time i.e., the sleeve and the shaft; [0033]; [0040]; and the sensors of Skalyni detect the patients endocervical canal and uterine cavity; [0091]).
Modified Prior fails to disclose wherein the second sensor array comprises a capacitive sensor array and wherein the first sensor array comprises a plurality of impedance sensors.
However, Narkiss teaches position sensors may be selected from the group of capacitive sensors and impedance sensors ([0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second sensor array of modified Prior to comprise a capacitive sensor array and the first sensor array of modified Prior to comprise a plurality of impedance sensors in light of the teachings of Narkiss as both capacitive and impedance sensors were known in the prior art to be position sensors. Thus, all 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 would have yielded the predictable result of positioning sensors being positioned on the sleeve and the shaft.
Regarding claim 7, modified Prior discloses wherein the impedance sensors (position sensors 161 of Prior modified by Narkiss to be impedances sensors) are configured to identify a tissue-air interface (as the position sensors of Prior are used to identify a location of any element of the UM, including the sleeve, overlaid with CT scan or images of the patient’s anatomy in real-time as a single image or video feed on a display; [0033]; i.e., configured to identify a tissue-air interface or opening of the vagina).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2021/0275257 A1) in view of Skalyni (US 2013/0206147 A1), as applied to claim 1 above, and further in view of Gomez et al. (US 2022/0160448 A1).
Regarding claim 8, modified Prior fails to disclose wherein the second plurality of sensors includes an encoder, wherein the encoder is associated with a motor for moving the sleeve relative to the shaft.
However, Gomez teaches position sensors may include encoders to provide sensor data describing the rotation and orientation of motor shafts ([0038]) i.e., sensors comprising encoders associated with a motor for moving a shaft.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second plurality of sensors of modified Prior to include at least one encoder as taught by Gomez in order to sense orientation of the sleeve relative to the shaft.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2021/0275257 A1) in view of Skalyni (US 2013/0206147 A1), as applied to claim 1 above, and further in view of Stern (US 2014/0330133 A1).
Regarding claims 9-10, modified Prior fails to disclose wherein the shaft includes visual indicia, wherein the second plurality of sensors includes an optical sensor configured to sense the visual indicia, wherein the optical sensor is secured to the sleeve, wherein the optical sensor is configured to track movement of the visual indicia of the shaft relative to the sleeve.
However, Stern teaches a medical apparatus with a shaft (guidewire; Fig. 7C) including visual indicia (position markings or other detectable indicia; [0065]), an optical sensor (sensor on the catheter 712 such as camera 724) secured to a sleeve (catheter 712), the optical sensor configured to sense the visual indicia (as the indicia are read or detected by the sensor on the catheter; [0065]), wherein the sensor is configured to track movement of the visual indicia of the shaft relative to the sleeve (as the sensor tracks movement of the catheter over the guidewire by detecting indicia to detect the rate of travel of the catheter relative to the guidewire; [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of modified Prior to include visual indica as claimed and to modify the sleeve of modified Prior to include an optical sensor as claimed in light of the teachings of Stern in order to detect the rate of travel to allow tracking to the sleeve position relative to the shaft.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prior et al. (US 2021/0275257 A1) in view of Skalyni (US 2013/0206147 A1), as applied to claim 1 above, and further in view of DiMaio et al. (US 2019/0216555 A1).
Regarding claims 12 and 14, modified Prior discloses a system (robotic system 900; Fig. 9; wherein system 900 is for operating the uterine manipulator 100; [0060]), comprising:(a) the apparatus (uterine manipulator 100) of claim 1 (see claim 1 above); and (b) a controller (control device 904), wherein the controller is in communication with the first and second plurality of sensors (as the control device 904 is in communication with the display 906 which displays images of the patient’s anatomy overlaid with images of a position of the uterine manipulator derived from the position sensors 161; [0060]).
Prior fails to explicitly disclose wherein the controller is configured to compute a remote center of motion based on information from the first and second plurality of sensors, wherein the controller is configured to recompute the remote center of motion based on information from the first and second plurality of sensors during a procedure.
However, DiMaio teaches a robotic system (Figs. 2-3) comprising a controller (controller 302) for controlling a robotic arm ([0118]), similar to robotic arms 902, 903 of Prior, wherein the controller (302) is in communication with a plurality of sensors (pose or position sensors 309; [0118]), wherein the controller is configured to compute a remote center of motion based on information from the plurality of sensors (as the processor 302 can determine the location of the remote center of motion based on the information from the pose sensors 309; [0118]). DiMaio teaches wherein the controller (302) is configured to recompute the remote center of motion based on information from the plurality of sensors (309) during a procedure (during the surgery, based on the signals from the pose sensors 309, the processor 302 can control the remotely controllable arm 106 to maintain the position of the arm in accordance to the remote center of motion; [0132]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of modified Prior to be configured to compute a remote center of motion based on information from the plurality of sensors, wherein the controller is configured to recompute the remote center of motion based on information from the plurality of sensors during a procedure as taught by DiMaio in order to constrain motion of the apparatus to reduce trauma to the patient.
Regarding claim 13, modified Prior discloses the invention as claimed above, and Prior further discloses the plurality of sensors (multiple sensors 161) may be arranged at various locations about the colpotomy cup (160; [0040]) including at proximal end of the colpotomy cup and a distal end of the colpotomy cup i.e. longitudinally spaced apart from each other along a length of the cup ([0040]), but fails to explicitly disclose wherein the plurality of sensors define a first sensor array associated with the sleeve and a second sensor array associated with the shaft, wherein the controller is configured to combine information from the first sensor array and the second sensor array to compute the remote center of motion.
However, Skalyni teaches a uterine apparatus comprising a shaft (shaft 560; Figs. 15A-16), a sleeve (seal assembly 500; Figs. 14A-14B) slidably coupled to the shaft (as the shaft 560 is slid within the seal assembly 500), and a plurality of sensors i.e. an array (position sensors; [0091]) on the shaft and the sleeve ([0091]), wherein the position sensors are configured to locate a position of the sleeve relative to one or more anatomical features of a patient (i.e., the patients endocervical canal and uterine cavity; [0091]), wherein the plurality of sensors are further configured to locate a position of the sleeve relative to the shaft (as the position sensors determine the axial relationship between the sleeves; [0091]). The plurality of position sensors on the shaft and the sleeve are for determining the axial relationship between the shaft and the sleeve to determine proper deployment of the apparatus relative to a patients endocervical canal and uterine cavity ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of sensors of Prior to be positioned in a first sensor array including a plurality of sleeve along a length of the shaft and a second sensor array including a plurality of shaft sensors along the shaft in light of the teachings of Prior and Skalyni in order to better determine the axial relationship between the shaft and the sleeve to determine proper deployment of the apparatus. Further, all the claimed elements were known in the prior art (plurality of position sensors being placed on a shaft, a sleeve, and a plurality of position sensors being spaced apart longitudinally) 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 would have yielded the predictable result of being able to track the position of the apparatus.
It is noted that the controller (302 of DiMaio) of modified Prior is configured to combine the information from a plurality of sensors (sensors 309) in order to compute the remote center of motion ([0118]); therefore, the combination of sensor arrays of modified Prior would also be used by the controller of DiMaio, as discussed above.
Regarding claim 15, modified Prior fails to disclose at least one position marker, wherein the at least one position marker is configured to be associated with the patient to detect movement of the patient, wherein the controller is configured to recompute the remote center of motion upon detection of movement of the patient as indicated by the at least one position marker.
However, DiMaio teaches at least one position marker (estimated pivot point of the robotic arm; [0101]), wherein the at least one position marker is configured to be associated with the patient to detect movement of the patient (as changes in the estimated pivot point indicate that the patient has moved; [0101]), wherein the controller (302) is configured to recompute the remote center of motion upon detection of movement of the patient as indicated by the at least one position marker (as the processor 302 has an opportunity to take corrective action when the estimated pivot point has an error output when compared to a desired pivot point; [0101]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Prior to include at least one position marker, wherein the at least one position marker is configured to be associated with the patient to detect movement of the patient, wherein the controller is configured to recompute the remote center of motion upon detection of movement of the patient as indicated by the at least one position marker as taught by DiMaio in order to take corrective action when the patient moves to reduce trauma to the patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached on (571)272-7134. 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.
/SARAH A LONG/Primary Examiner, Art Unit 3771