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 Amendment
This Office action is in response to the response filed September 10, 2025. Claims 18-20 stand withdrawn. Claims 1-17 are pending and addressed below.
Response to Arguments
Applicant's arguments filed September 10, 2025 have been fully considered but they are not persuasive. Applicant argues the reference of Singh (U.S. Pub. No. 20160081717) does not teach the limitation of “a locking ring coupled to the proximal sleeve” as recited in claim 1 because Singh does not teach the locking ring 84 in direct contact with the proximal sleeve 94. Examiner respectfully disagrees. The claims do not recite the locking ring is directly coupled to the proximal sleeve but broadly recites “coupled.” It is possible for components to be coupled to one another without being directly coupled to one another. Singh teaches the lock ring 84 is coupled to the proximal sleeve 94 through connection with forceps holder 70 (see Fig. 12). Applicant further argues that forceps 70 and by extension locking nut 84 are only shown in contact with tube 94 which cannot be considered coupled because there is no link or connection. However, two objects being in contact with each other by definition means the objects are connected. Additionally, Singh teaches the forceps 70 and by extension locking nut 84 can be used to position (i.e., move and lock) the tube 94 (see paragraphs [0206] and [0208]). The forceps 70 and locking nut 84 would not be able to position the tube 94 if they were not coupled to it in some fashion. Finally, under the broadest reasonable interpretation, any part of the device can be considered “coupled” to another by nature of all components being a part of a unitary device; therefore, the lock ring 84 of Singh is considered “coupled” to the proximal sleeve 94, and Applicant’s arguments are unpersuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 7-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Gross et. al. (U.S. Pub. No. 20110022073) hereinafter, “Gross,” in view of Singh et. al. (U.S. Pub. No. 20160081717) hereinafter, “Singh.”
Regarding claim 1, Gross teaches an apparatus, comprising:
(a) a shaft (34; Fig. 1) including a distal shaft end (see Fig. 1);
(b) a sleeve (26; Fig 1) slidably coupled to the shaft (34; pp. [0323]), wherein the sleeve (26) includes a distal sleeve end and a proximal sleeve end (see Fig. 1);
(c) a colpotomy cup (“fornix engaging structure” 24; Fig. 1) fixedly secured to the distal sleeve end (see Fig. 1; pp. [0288]);
(d) an inflatable balloon (32; Fig. 1 positioned over the shaft (34) near the distal shaft end (see Fig. 1) such that the inflatable balloon (32) is configured to manipulate an anatomical structure via movement of the shaft (34; see Fig. 1); and
(e) at least one sensor (48; Fig. 1) configured to detect a fluid pressure within the inflatable balloon (32, pp. [0326]), wherein the at least one sensor (48) is configured to generate at least one feedback signal based on the detected fluid pressure (pp. [0328]).
or (e) at least one sensor (48) is configured to detect a force acting upon the inflatable balloon (32 pp. [0332]; it is noted, the fluid within the balloon can be considered a force acting upon the inflatable balloon), wherein the at least one sensor (48) is configured to generate the feedback signal based on the detected force (pp. [0332]).
However, Gross does not explicitly disclose a locking ring as claimed.
Singh teaches a uterine manipulator (Fig. 12) with locking mechanism (70; Fig. 11) including a locking ring (84; Fig. 11) coupled to the proximal sleeve end (94; Fig. 12, it is noted, locking ring is considered “coupled” to the proximal sleeve by nature of all components being a part of a unitary device) and concentric with the shaft (12; Fig. 12), wherein rotation of the lock ring (84) to a first angular position relative to the sleeve (94) provides an unlocked state (pps. [0206], [0208] and [0027]) and rotation of the lock ring (84) to a second angular position relative to the sleeve (94) provides a locked state (pps. [0206], [0208] and [0027]).
Singh is considered to be analogous to the claimed invention because it is in the same field of uterine manipulators. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sleeve of Gross to incorporate the teachings of Singh by providing a locking mechanism with a locking ring on the proximal end of the sleeve. Doing so would allow a surgeon to selectively lock the sleeve relative to the shaft which would obviate the surgeon from having to hold the uterine manipulator in place once the device has been properly positioned.
Regarding claim 2, Gross in view of Singh teaches the invention as discussed above in claim 1. Gross further teaches the at least one sensor (48) is configured to detect a force acting upon the inflatable balloon (32 pp. [0332]; it is noted, the fluid within the balloon can be considered a force acting upon the inflatable balloon), wherein the at least one sensor (48) is configured to generate the feedback signal based on the detected force (pp. [0332]).
Regarding claim 7, Gross in view of Singh teaches the invention as discussed above in claim 1. Gross teaches the at least one sensor (48) is configured to detect a fluid pressure within the inflatable balloon (32; pp. [0328]), wherein the at least one sensor (48) is configured to generate the feedback signal based on the detected fluid pressure (“parameters detected,” pp. [0328]).
Regarding claim 8, Gross in view of Singh teaches the invention as discussed above in claim 7. Gross further teaches the at least one sensor (48) is positioned proximally (see Fig. 1) relative to the inflatable balloon (32).
Regarding claim 9, Gross in view of Singh teaches the invention as discussed above in claim 8. Gross further teaches the at least one sensor (48) is positioned proximally (see Fig. 1) relative to the shaft (34).
Regarding claim 10, Gross in view of Singh teaches the invention as discussed above in claim 9. Gross further teaches a pressurized fluid source (“pump” 50; Fig. 1; pp. [0328]) configured to selectively inflate the inflatable balloon (32), wherein the at least one sensor (48) is positioned inline between the shaft (34) and the pressurized fluid source (50; see Fig. 1).
Regarding claim 11, Gross in view of Singh teaches a system, comprising:
(a) the apparatus of claim 1; and
(b) a controller (“control unit” 52; Fig. 1), wherein the controller (52) is in operative communication with the at least one sensor (48) for receiving the at least one feedback signal from the at least one sensor (48; pp. [0328]), wherein the controller (52) is configured to monitor the manipulation of the anatomical structure by the inflatable balloon (48) based on the at least one feedback signal (pp. [0328]).
Regarding claim 12, Gross in view of Singh teaches the invention as discussed above in claim 11. Gross further teaches the at least one sensor (48) is configured to detect the fluid pressure within the inflatable balloon (32; pp. [0328]), wherein the at least one sensor (48) is configured to generate the feedback signal based on the detected fluid pressure (pp. [0328]), wherein the controller (352) is configured to determine the force acting upon the inflatable balloon (32) based on the detected fluid pressure (pp. [0328]; it is noted, the fluid within the balloon can be considered a force acting upon the inflatable balloon).
Regarding claim 13, Gross in view of Singh teaches the invention as discussed above in claim 11. Gross further teaches the controller (52) is configured to adjust the fluid pressure within the inflatable balloon (32) based on the at least one feedback signal (pp. [0328]).
Regarding claim 14, Gross in view of Singh teaches the invention as discussed above in claim 11. Gross further teaches the controller (52) is configured to determine whether the force acting upon the inflatable balloon (32) exceeds a predetermined threshold (“non-zero pulsating component” pp. [0332]).
Regarding claim 16, Gross discloses a system, comprising:
(a) an apparatus (Fig. 1), comprising:
(i) a shaft (34; Fig. 1) including a distal shaft end (see Fig. 1),
(ii) a sleeve (26; Fig. 1) slidably coupled to the shaft (34; pp. [0323]), wherein the sleeve (26) includes a distal sleeve end and a proximal sleeve end (see Fig. 1),
(iii) a colpotomy cup (“fornix engaging structure” 24; Fig. 1) fixedly secured to the distal sleeve end (see Fig. 1; pp. [0288]), and
(iv) an inflatable balloon (32; Fig. 1) positioned over the shaft (34) near the distal shaft end (see Fig. 1) such that the inflatable balloon (32) is configured to manipulate an anatomical structure via movement of the shaft (see Fig. 1);
(b) at least one sensor (48; Fig. 1) configured to generate at least one feedback signal (“parameters detected,” pp. [0328]) indicative of a force acting upon the inflatable balloon (34; pp. [0332]; it is noted, the fluid within the balloon can be considered a force acting upon the inflatable balloon); and
(c) a controller (52; Fig. 1), wherein the controller (52) is in operative communication with the at least one sensor (48) for receiving the at least one feedback signal from the at least one sensor (48; pp. [0328]), wherein the controller (52) is configured to monitor the manipulation of the anatomical structure by the inflatable balloon (32) based on the at least one feedback signal (pp. [0328]).
However, Gross does not explicitly disclose a locking ring as claimed.
Singh teaches a uterine manipulator (Fig. 12) with locking mechanism (70; Fig. 11) including a locking ring (84; Fig. 11) coupled to the proximal sleeve end (94; Fig. 12, it is noted, locking ring is considered “coupled” to the proximal sleeve by nature of all components being a part of a unitary device) and concentric with the shaft (12; Fig. 12), wherein rotation of the lock ring (84) to a first angular position relative to the sleeve (94) provides an unlocked state (pps. [0206], [0208] and [0027]) and rotation of the lock ring (84) to a second angular position relative to the sleeve (94) provides a locked state (pps. [0206], [0208] and [0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sleeve of Gross to incorporate the teachings of Singh by providing a locking mechanism with a locking ring on the proximal end of the sleeve. Doing so would allow a surgeon to selectively lock the sleeve relative to the shaft which would obviate the surgeon from having to hold the uterine manipulator in place once the device has been properly positioned.
Regarding claim 17, Gross in view of Singh teaches the invention as discussed above in claim 16. Gross further teaches the at least one sensor (48) is configured to detect a fluid pressure within the inflatable balloon (32; pp. [0328]), wherein the at least one sensor (48) is configured to generate the feedback signal based on the detected fluid pressure (pp. [0328]), wherein the controller (52) is configured to determine the force acting upon the inflatable balloon (32) based on the detected fluid pressure (pp. [0328]).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parys (U.S. Pub. No. 20160100862) in view of Bytheway et. al. (U.S. Pub. No. 20210223887) hereinafter, “Bytheway,” and further in view of Singh.
Regarding claim 1, Parys teaches an apparatus, comprising:
(a) a shaft (102; Fig. 3) including a distal shaft end (see Fig. 3);
(b) a sleeve (148; Fig 3) slidably coupled to the shaft (102; pp. [0117]), wherein the sleeve (148) includes a distal sleeve end and a proximal sleeve end (see Fig. 3);
(c ) a locking mechanism (176; Fig. 3) coupled to the proximal sleeve (see Fig. 3);
(d) a colpotomy cup (146; Fig. 3) fixedly secured to the distal sleeve end (see Fig. 3; pp. [0124]); and
(e) an inflatable balloon (106; Fig. 3) positioned over the shaft (102) near the distal shaft end (see Fig. 3) such that the inflatable balloon (106) is configured to manipulate an anatomical structure via movement of the shaft (102; see Figs. 9 and 10).
However, Parys does not explicitly disclose a sensor as claimed but does disclose the device can be used for gynecological diagnostic procedures (pp. [0003]).
Bytheway teaches a balloon (Fig. 10; pp. [0099]) with at least one sensor (“peripheral electrodes” 1008, pp. [0095]; Fig. 10) configured to detect a force acting upon the inflatable balloon (pp. [0084]), wherein the at least one sensor (1008) is configured to generate the feedback signal based on the detected force (by measuring a change in capacitance, pp. [0085]).
Bytheway is considered to be analogous to the claimed invention because it is in the same field of expandable balloons. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of Parys to incorporate the teachings of Bytheway by providing force sensing electrodes on the exterior of the balloon. Doing so would provide the device with more diagnostic options within the uterus such as measuring an inside diameter, a width, a length, an internal pressure, a strength of the inside surface, a shape, or combinations thereof (pp. [0096]) or finding the presence of an obstruction (pp. [0097]) as taught by Bytheway.
Further, Parys does not explicitly disclose the locking mechanism as a locking ring as claimed.
Singh teaches a uterine manipulator (Fig. 12) with locking mechanism (70; Fig. 11) including a locking ring (84; Fig. 11) coupled to the proximal sleeve end (94; Fig. 12, it is noted, locking ring is considered “coupled” to the proximal sleeve by nature of all components being a part of a unitary device) and concentric with the shaft (12; Fig. 12), wherein rotation of the lock ring (84) to a first angular position relative to the sleeve (94) provides an unlocked state (pps. [0206], [0208] and [0027]) and rotation of the lock ring (84) to a second angular position relative to the sleeve (94) provides a locked state (pps. [0206], [0208] and [0027]).
Singh is considered to be analogous to the claimed invention because it is in the same field of uterine manipulators. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking mechanism of Parys to incorporate the teachings of Singh by providing a locking ring. Doing so would be a simple substitution of one known locking mechanism for another to obtain predictable results of providing a uterine manipulator capable of locking the shaft relative the sleeve with a reasonable expectation of success.
Regarding claim 2, modified Parys teaches the invention as discussed above in claim 1. Bytheway further teaches the at least one sensor (1008) is configured to detect a force acting upon the inflatable balloon (pp. [0084]), wherein the at least one sensor (1008) is configured to generate the feedback signal based on the detected force (by measuring a change in capacitance, pp. [0085]).
Regarding claim 3, modified Parys teaches the invention as discussed above in claim 2. Bytheway further teaches the at least one sensor (1008) is positioned on an exterior of the inflatable balloon (pp. [0050]).
Regarding claim 4, modified Parys teaches the invention as discussed above in claim 3. Bytheway further teaches the at least one sensor (1008) includes a plurality of sensors in a circumferential array on the exterior of the inflatable balloon (see Fig. 10, pp. [0054]).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parys in view of Bytheway in view of Singh and further in view of Olson (U.S. Pub. No. 20210361220).
Regarding claim 5, modified Parys teaches the invention as discussed above in claim 2. Bytheway further teaches the at least one sensor (1008) includes at least one electrode (“peripheral electrodes”, pp. [0095]) configured to detect the force acting upon the inflatable balloon (pp. [0084]).
However, Bytheway discloses the detection of force from surrounding tissue is based on a change in capacitance (pp. [0085]) and not a change in resistance as claimed.
Olson teaches at least one sensor (204; Fig. 2) on an inflatable balloon (200; Fig. 2; pp. [0040]) includes at least one electrode (pp. [0040]) configured to detect the force acting upon the inflatable balloon from surrounding tissue based on a change in resistance of the at least one electrode (pp. [0071] & [0079]).
Olson is considered to be analogous to the claimed invention because it is in the same field of inflatable balloons. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of Parys in view of Bytheway to incorporate the teachings of Olson by providing electrodes that measure force from surrounding tissue by a change in resistance. Doing so would be a simple substitution of one known method of electrodes detecting force from surrounding tissue for another to obtain the predictable results of providing a balloon capable of sensing force for running diagnostics within the uterus with a reasonable expectation of success.
Regarding claim 6, modified Parys teaches the invention as discussed above in claim 5. Olson further teaches the at least one electrode (204) is compliant (pp. [0043]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes of Parys in view of Bytheway to incorporate the teachings of Olson by providing the electrodes to be compliant. Doing so would allow the electrodes to stretch and deform and remain conductive while the balloon inflates and deflates.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Singh and further in view of Sigmon et. al. (U.S. Pub. No. 20200101271) hereinafter, “Sigmon.”
Regarding claim 15, Gross in view of Singh teaches the invention as discussed above in claim 14.
However, Gross does not explicitly disclose the controller is configured to generate a warning in response to determining that the force acting upon the inflatable balloon exceeds the predetermined threshold.
Sigmon teaches a controller (“force gauge” 314; Fig. 4F) configured to generate a warning in response to determining that a force acting upon an inflatable balloon (308; Fig. 4F) exceeds the predetermined threshold (pp. [0110]).
Sigmon is considered to be analogous to the claimed invention because it is in the same field of pressure/force sensing balloons. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Gross to incorporate the teachings of Sigmon by generating a warning. Doing so would indicate to the operator when the inflatable balloon has reached a critical point as taught by Sigmon (pp. [0110]), which would improve safe use of the device.
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771