DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Election/Restrictions
Applicant’s election without traverse of Group 1 (device claims) in the reply filed on 24 September 2025 is acknowledged.
Claims directed towards Group 2 (method) were cancelled. Election was made without traverse in the reply filed on 24 September 2025.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 15, 18-20, 23, 24, 27-29, 31-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morozov (US Patent Publication 2012/0109124) in view of Feuer et al. (US Patent Publication 2008/0109010).
Claim 15: Morozov’124 teaches a uterine manipulator (10; paragraph [0001]) , comprising:
a shaft (14) including a proximal end, and a distal end (towards 22);
a manipulator handle (proximal end of 14) coupled to the proximal end of the shaft;
a cutting assembly rotatably disposed about the shaft, the cutting assembly including:
a tube (18) rotatably disposed about the shaft (14) (paragraph [0027], [0028]);
a cutting handle (20; paragraph [0025], [0026]) coupled to a proximal portion of the tube (18) (Figure 1);
a cup (12) to receive at least a portion of a fornix of a patient (Figure 3), the cup being coupled to a distal portion of the tube (18) (Figure 1);
a retractable cutter (26) extendable distally with respect to the cup (paragraph [0025], [0026]), the retractable cutter being movable from a retracted position to an extended position (paragraph [0025]), wherein the retractable cutter extends distally beyond the cup when in the extended position (Figure 1), wherein the cutting assembly can be rotated about the shaft by the cutting handle to allow the retractable cutter to travel in a circle at a junction of a cervix and a vagina to permit transection of a uterus and a cervix from a vagina (paragraph [0027], [0028]);
an outer tubular member (inner ring of 16) surrounding the tube (18) of the cutting assembly to permit the cutting assembly to be rotated within the outer tubular member while the outer tubular member is held stationary (paragraph [0023]).
Morozov’124 teaches the tube of the cutting assembly has an additional lumen (28) extending along the length of the device. This additional lumen is located in the wall of the tube (18) and therefore is not a further tubular member on the outside of the tube 18, as recited in claim 15.
Like Morozv’124, Feuer’010 teaches a manipulator for using the female reproductive system (paragraph [0002]). Feuer’010 teaches a device having a tube (12) including a main central lumen (24). As in Morozov’124, this tube (12) has an additional lumen (54) within the wall of the tube (Figure 5a). Alternately, Feuer’010 teaches providing this lumen in the form of a tube on the outer surface of the tube (56; Figure 5b).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124, by providing the additional lumen (28)) along the outer wall of the tube, as taught by Feuer’010, because Feuer’010 teaches these two configurations can be reasonably substituted for one another with predictable results. Further, such an external lumen would be advantageous creates because it creates additional distance between Morzov’124’s electrode 27 and the rest of the other components of the device.
In the resulting device of Morozov’124 in view of Feuer’010, Morozov’124 additional lumen (28) is in the form of a tubular member arranged on the outside of the tube (18), as taught by Feuer’010 in Figure 5b. This tubular member will be located radially inward from Morozov’124’s outer tubular member (inner ring of 16).
Claim 24: Morozov’124 teaches a uterine manipulator (10; paragraph [0001]) , comprising:
a shaft (14) including a proximal end, and a distal end (towards 22);
a manipulator handle (proximal end of 14) coupled to the proximal end of the shaft;
a cutting assembly rotatably disposed about the shaft, the cutting assembly including:
a tube (18) rotatably disposed about the shaft (14) (paragraph [0027], [0028]);
a cutting handle (20; paragraph [0025], [0026]) coupled to a proximal portion of the tube (18) (Figure 1);
a cup (12) to receive at least a portion of a fornix of a patient (Figure 3), the cup being coupled to a distal portion of the tube (18) (Figure 1);
a retractable cutter (26) extendable distally with respect to the cup (paragraph [0025], [0026]), the retractable cutter being movable from a retracted position to an extended position (paragraph [0025]), wherein the retractable cutter extends distally beyond the cup when in the extended position (Figure 1), wherein the cutting assembly can be rotated about the shaft by the cutting handle to allow the retractable cutter to travel in a circle at a junction of a cervix and a vagina to permit transection of a uterus and a cervix from a vagina (paragraph [0027], [0028]);
an outer tubular member (inner ring of 16) surrounding the tube (18) of the cutting assembly to permit the cutting assembly to be rotated within the outer tubular member while the outer tubular member is held stationary (paragraph [0023]).
Morozov’124 teaches the tube of the cutting assembly has an additional lumen (28) extending along the length of the device for receiving an electrical conductor (27). The electrical conductor (27) extends proximally from the cutter (26) (paragraph [0025]). This additional lumen (28), and therefore the electrical conductor, is located in the wall of the tube (18) and therefore the additional lumen is not a further tubular member on the outside of the tube 18, as recited in claim 24. Further, the electrical conductor (27) is not located a location which is radially outward with respect o the exterior surface of the tube (18), as recited in claim 24.
Like Morozv’124, Feuer’010 teaches a manipulator for using the female reproductive system (paragraph [0002]). Feuer’010 teaches a device having a tube (12) including a main central lumen (24). As in Morozov’124, this tube (12) has an additional lumen (54) within the wall of the tube (Figure 5a). Alternately, Feuer’010 teaches providing this lumen in the form of a tube on the outer surface of the tube (56; Figure 5b).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124, by providing the additional lumen (28)) along the outer wall of the tube, as taught by Feuer’010, because Feuer’010 teaches these two configurations can be reasonably substituted for one another with predictable results. Further, such an external lumen would be advantageous creates because it creates additional distance between Morzov’124’s electrode 27 and the rest of the other components of the device.
In the resulting device of Morozov’124 in view of Feuer’010, Morozov’124 additional lumen (28) is in the form of a tubular member arranged on the outside of the tube (18), as taught by Feuer’010 in Figure 5b. This tubular member will be located radially inward from Morozov’124’s outer tubular member (inner ring of 16). The electrical conductor (27) will be within the tubular member on the outside of the tube (18), and therefore also be located radially inward from Morozov’124’s outer tubular member (inner ring of 16).
Claim 32: Morozov’124 teaches a uterine manipulator (10; paragraph [0001]) , comprising:
a shaft (14) including a proximal end, and a distal end (towards 22);
a manipulator handle (proximal end of 14) coupled to the proximal end of the shaft;
a cutting assembly rotatably disposed about the shaft, the cutting assembly including:
a tube (18) rotatably disposed about the shaft (14) (paragraph [0027], [0028]);
a cutting handle (20; paragraph [0025], [0026]) coupled to a proximal portion of the tube (18) (Figure 1);
a cup (12) to receive at least a portion of a fornix of a patient (Figure 3), the cup being coupled to a distal portion of the tube (18) (Figure 1);
a retractable cutter (26) extendable distally with respect to the cup (paragraph [0025], [0026]), the retractable cutter being movable from a retracted position to an extended position (paragraph [0025]), wherein the retractable cutter extends distally beyond the cup when in the extended position (Figure 1), wherein the cutting assembly can be rotated about the shaft by the cutting handle to allow the retractable cutter to travel in a circle at a junction of a cervix and a vagina to permit transection of a uterus and a cervix from a vagina (paragraph [0027], [0028]);
an outer tubular member (inner ring of 16) surrounding the tube (18) of the cutting assembly to permit the cutting assembly to be rotated within the outer tubular member while the outer tubular member is held stationary (paragraph [0023]); and
a mechanical actuator (20) mechanically coupled to the retractable cutter (26), the mechanical actuator being operable to mechanically advance and retract the cutter between the extended and retracted positions (paragraphs [0025]-[0026]).
Morozov’124 teaches the tube of the cutting assembly has an additional lumen (28) extending along the length of the device. This additional lumen is located in the wall of the tube (18) and therefore is not a further tubular member on the outside of the tube 18, as recited in claim 15.
Like Morozv’124, Feuer’010 teaches a manipulator for using the female reproductive system (paragraph [0002]). Feuer’010 teaches a device having a tube (12) including a main central lumen (24). As in Morozov’124, this tube (12) has an additional lumen (54) within the wall of the tube (Figure 5a). Alternately, Feuer’010 teaches providing this lumen in the form of a tube on the outer surface of the tube (56; Figure 5b).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124, by providing the additional lumen (28)) along the outer wall of the tube, as taught by Feuer’010, because Feuer’010 teaches these two configurations can be reasonably substituted for one another with predictable results. Further, such an external lumen would be advantageous creates because it creates additional distance between Morzov’124’s electrode 27 and the rest of the other components of the device.
In the resulting device of Morozov’124 in view of Feuer’010, Morozov’124 additional lumen (28) is in the form of a tubular member arranged on the outside of the tube (18), as taught by Feuer’010 in Figure 5b. This tubular member will be located radially inward from Morozov’124’s outer tubular member (inner ring of 16).
Claim 18, 27, 33: Morozov’124 teaches a deployable anchor (22) operable coupled to the distal end of the shaft (14), the deployable anchor (22) configured for being expanded within the uterus (paragraph [0022]; Figure 3).
Claim 19, 28: Morozov’124 teaches the anchor includes a surface that expands radially outward when deployed (anchor 22 is an expandable balloon; paragraph [0022]; Figure 3).
Claim 20, 29: Morozov’124 teaches the cutter (26) is configured to be electrified with electrical current (paragraph [0025]).
Claim 23, 31, 34: Morozov’124 teaches an electrosurgical unit (“standard operating room electrosurgical generator”, paragraph [0025]) coupled to the cutter (26) (paragraph [0025]).
Claims 16, 17, 21 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morozov’124 in view of Feuer’010, as applied to claim 15, further in view of Brecheen et al. (US Patent Publication 2012/0143210).
Claim 16, 25: Morozov’124 fails to teach the retractable cutter passes through a channel defined in the cup.
Like Morozov’124, Brecheen’210 teaches a cup (28) for receiving a fornix of a patient (Figure 7b). The cup includes a channel (between elements 28b, 28c) for receiving a retractable cutter (30; paragraph [0069]). The cutter (30) slides with respect to the channel defined in the cup (28) when it is advanced and retracted (paragraph [0069]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124 by providing the cup with a channel for receiving the cutter, as taught by Brecheen’210, in order to create a clear path for the proximal portion of the blade so that it can move without engaging with tissue.
Claim 17, 26: Morozov’124 fails to teach the cutter includes a blade.
Like Morozov’124, Brecheen’210 teaches a cutter for use in a hysterectomy procedure (paragraph [0002]). Brecheen’210 teaches the cutter can be any known cutter, including a sharpened blade (paragraph [0072]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124 such that the cutter includes a blade, as taught by Brecheen’210, because the substitution of one known element (e.g. Morozov’124’s electrosurgical needle) with another (e.g. a cutter with a blade) would have yielded predictable results in light of Brecheen’210’s disclosure that any known cutter can be used to perform the step of cutting tissue during a hysterectomy procedure (paragraph [0072]). One of ordinary skill in the art would understand that the substitution for an electrosurgical cutter for a cutter with a blade would perform the predictable result of cutting tissue during surgery.
Claim 21, 30: Morozov’124 fails to teach the cutter is in a bipolar configuration.
Like Morozov’124, Brecheen’210 teaches a cutter for use in a hysterectomy procedure (paragraph [0002]). Brecheen’210 teaches the cutter can be any known cutter, including a monopolar cutter, as taught by Morozov’124, or a bipolar cutter (paragraph [0072]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Morozov’124 such that the cutter includes a blade, as taught by Brecheen’210, because the substitution of one known element (e.g. Morozov’124’s monopolar cutting needle) with another (e.g. a bipolar cutter) would have yielded predictable results in light of Brecheen’210’s disclosure that any known cutter can be used to perform the step of cutting tissue during a hysterectomy procedure (paragraph [0072]). One of ordinary skill in the art would understand that the substitution for a monopolar cutter for a bipolar cutter would perform the predictable result of cutting tissue during surgery.
Claim 22: Morozov’124 teaches a pneumooccluder (16) disposed on the outer tubular member (paragraph [0024]) but fails to disclose the pneumooccluder (16) is in the form of an inflatable member.
Like Morozov’124, Brecheen’210 teaches a manipulator for use in a hysterectomy procedure (paragraph [0002]). Brecheen’210 teaches the manipulator can have an inflatable pneumooccluder (18) coupled to an inflation tube (32). Brecheen’210 teaches the pneumooccluder (18) functions to prevent gas, which is used to inflate the abdomen during a hysterectomy procedure to allow for visualization, from escaping from the body prematurely (paragraph [0077]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention taught by Morozov’124, with an inflatable pneumooccluder, as taught by Brecheen’210, in order to provide a pneumooccluder which can expand to a range of dimensions, as needed, during a hysterectomy procedure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,730,516 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,730,516. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘516 patent, as outlined in the chart below:
Claims of present application 18/345981
Anticipated by claims of 11,730,516
15
1
16
2
17
3
18
4
19
5
20
6
21
7
22
1
23
8
24
1
25
2
26
3
27
4
28
5
29
6
30
7
31
1
32
1
33
4
34
1
Claims 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of U.S. Patent No. 11,413,069. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘069 patent, as outlined in the chart below:
Claims of present application 18/345981
Anticipated by claims of 11,413,069
15
15
16
16
17
17
18
15
19
15
20
15
21
15
22
15
23
15
24
15
25
16
26
17
27
15
28
15
29
15
30
15
31
15
32
15
33
16
34
17
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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 at 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.
Lindsey Bachman
/L.B./Examiner, Art Unit 3771 11 December 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771