DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 15 June 2026.
Notice of Pre-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 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.
Response to Arguments
Claim 15 was amended to recite a pneumooccluder “rotatably disposed on the outer tubular member to permit relative rotation between the pneumooccluder and the outer tubular member”. A pneumooccluder was previously recited in dependent claim 22 and rejected with a secondary reference - Brecheen’210. Applicant argues the amended limitations are not taught by Brecheen’210. The Office agrees Brecheen’210 does not teach the pneumooccluder is disposed on an outer tubular assembly and rotatable relative to this outer tubular assembly. However, this limitation is new matter and not supported by the specification, as filed, See the 35 USC 112a rejection below.
Applicant argues claim 24 was amended to recite “"an actuator mechanically coupled to the retractable cutter, wherein an electrical circuit is completed to the retractable cutter to electrically energize the retractable cutter when the actuator is operated to move the retractable cutter from the retracted position to the extended position." And this limitation is not taught by the cited portion of the cited references. Examiner updated the rejection with citations to show that these limitations are taught by Morozov’124.
Claim 32 was amended to recite “a mechanical actuator to advance and retract the cutter…which is mechanically independent from the cutting handle to permit rotation independently from the extension and retraction of the cutter”. Applicant argues this overcomes the rejection over Morozov’124 in view of Feuer’010. This argument is persuasive because Morozov’124 teaches element 20 functions to allow extension/retraction of the cutter and rotates the cutter (paragraph [0025], [0027). However, upon further consideration, Brecheen’210 is relied on to render this limitation obvious. See the updated rejection below.
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.
Claim 15-21, 23-28, 30-31 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 15 was amended to recite a pneumooccluder “rotatably disposed on the outer tubular member to permit relative rotation between the pneumooccluder and the outer tubular member”. This limitation is not supported in the disclosure, as filed.
The claim recites the outer tubular member permits “the cutting assembly to be rotated within the outer tubular member while the outer tubular member is held stationary”. Pneumooccluder 20 includes a balloon 86 disposed on an outer tubular member 90. Element 90 is disclosed as a bearing that allows relative rotation between the balloon 86 and shaft 14 and/or cutting assembly tube 76. See page 8, first full paragraph of the specification, as filed (paragraph [0035] of the published application): “As a result of the bearing 90, the shaft 14 and/or the cutting assembly tube 76 can be rotated without requiring rotation of the balloon 86. Because the balloon 86 can be set in place and does not need to be rotated when the shaft 14 or the cutting assembly 18 is rotated, the risk of losing pneumoperitoneum is greatly reduced.” There is no disclosure the balloon 86 rotates relative to the outer tubular member 90.
The specification does not disclose the combination of (a) a shaft 14, (b) a cutting assembly tube 18, (c) an outer tubular member 90 surrounding tube 18 and (d) a further tubular member 100, 102 outside the tube 18 and inside the outer tubular member 90 where the pneumooccluder 20/86 can rotate relative to the outer tubular member 90. There is no other tube/tubular member disclosed in the specification that can meet the requirements of an outer tubular member that rotates relative to the pneumooccluder.
Claim 24 was amended to “an electrical circuit is completed to the retractable cutter to electrically energize the retractable cutter”. Examiner expects this is a typographical error and Applicant intended to recite “an electrical circuit is coupled to the retractable cutter to electrically energize the retractable cutter”.
However, the specification does not disclose an electrical circuit coupled/completed to the cutter. Page 7, last paragraph of the specification as filed (paragraph [0034] of the published application) discloses an electrical connector 104, 106 coupled to the retractable cutter 84 and button 98 to supply a current to the cutter.
Therefore, claim 24 is contains new matter. To overcome the rejection, Examiner suggests amending the claim to recite an electrical connector coupled to the retractable cutter. Appropriate correction is required.
Any claim not specifically addressed is rejected based on its dependence from a base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 24, 27-28, 31 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 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 cutting assembly rotatably disposed about the shaft, the cutting assembly including:
a tube (18) rotatably disposed about the shaft (14) (paragraph [0027], [0028]);
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
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]);
an actuator (20) mechanically coupled to the retractable cutter (26; paragraph [0026]), wherein an a electrical circuit (27; electrical connector? See 112b rejection above) is completed (coupled? See 112b rejection above) to the retractable cutter (26; Figure 1; paragraph [0028]) when the actuator is operated to move the retractable cutter from the retracted position to the extended position (paragraph [0026] discloses the actuator 20 moves the cutter 26 between the extended and retracted position; paragraph [0028] discloses the cutter is connected to the electrical circuit/connector 27).
Claim 27: 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 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 31: Morozov’124 teaches an electrosurgical unit (“standard operating room electrosurgical generator”, paragraph [0025]) coupled to the cutter (26) (paragraph [0025]).
Claims 32-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morozov’124 in view of Feuer’010 in view of Brecheen et al. (US Patent Publication 2012/0143210).
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 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).
Morozov’124 does not teach the mechanical actuator for advancing and retracting the cutter is mechanically independent from the cutting handle for permitting rotation of the cutter independently from the extension and retraction.
Like Morozov’124, Brecheen’210 teaches a manipulator for use in a hysterectomy procedure (paragraph [0002]).
The manipulator includes a cutting assembly having a tube (12), a cup (28), and a retractable cutter (30) that is rotatable. Brecheen’210 teaches a cutting handle (20) connected to a proximal portion of tube for rotating the cutter 30 (paragraph [0071]).
Brecheen’210 further teaches a mechanical actuator (22) mechanically coupled to the retractable cutter (30) for advancing and retracting the cutter (paragraph [0070]). The mechanical actuator (22) is mechanically independent from the cutting handle (20) to permit rotation of the cutter independently from extension and retraction of the cutter. This arrangement is advantageous because it will prevent accidental retraction of the cutter during the colpotomy procedure, which could lead to incomplete separation of the uterus and the cervix.
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 Morozov’124 such handle for rotating the cutter is separate from the handle from advancing/retracting the cutter, as taught by Brecheen’210, in order to avoid accidental retraction of the cutter.
Claim 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 34: Morozov’124 teaches an electrosurgical unit (“standard operating room electrosurgical generator”, paragraph [0025]) coupled to the cutter (26) (paragraph [0025]).
Claims 25, 26 and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morozov’124, as applied to claim 24, further in view of Brecheen’210.
Claim 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 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 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.
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 24-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 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
24
1
25
2
26
3
27
4
28
5
29
6
30
7
31
1
32
1
33
4
34
1
Claims 24-34 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
24
15
25
16
26
17
27
15
28
15
29
15
30
15
31
15
32
15
33
16
34
17
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 22 July 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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