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
Applicant’s amendment, filed 25 November 2025, is acknowledged. Claims 1-5,7-13, 17, 18, and 20 are amended. Claims 6, 19, 21 and 22 are cancelled.
Claims 1-5, 7-18, 20 and 23 are pending in the instant application. Claims 3, 4, and 8 were previously withdrawn from consideration.
Response to Arguments
Applicant’s arguments, filed 25 November 2025, with respect to the objections to the drawings, the objections to claims 2, 5-7, 9-13, 17, 18, and 22 and the 112(b) rejections of claims 1, 2, 5-7 and 9-23, have been fully considered and are persuasive in light of the amendments. The objections to the drawings, the objections to claims 2, 5-7, 9-13, 17, 18, and 22 and the 112(b) rejections of claims 1, 2, 5-7 and 9-23 have been withdrawn.
Applicant’s arguments, with respect to the rejections of claim(s) 1, 6, 7, 12-14, 16-18 and 20 under 35 U.S.C. 102 (a)(1) have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, as necessitated by the amendment and upon further consideration, a new ground(s) of rejection is made in view of Forsell (US20110066254A1) and further in view of Forsell (US20190111206A1).
Claim Objections
Claims 2, 5, 7, and 9-13 are objected to because of the following informalities:
Claims 2, 5, and 7, lines 1-3 recite “the step of inserting an implantable constriction device into the body of the patient comprises inserting the implantable constriction device”. Claims 9-13, lines 1-3 recite “the step of inserting the implantable constriction device into the body of the patient comprises inserting an implantable constriction device”. Claims 2, 5, 7, and 9-13 should read --the step of inserting the implantable constriction device into the body of the patient comprises inserting the implantable constriction device-- for consistency.
Appropriate correction is required.
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.
Claims 1, 7, 12-14, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) and further in view of Forsell (US20190111206A1), further referred to as Forsell ‘206.
Regarding claim 1, Forsell discloses a method of implanting an implantable constriction device (Paragraph [0244]), the method comprises the steps of: making an incision in a body of the patient, for accessing a luminary organ (Paragraph [0247]), dissecting a portion of a luminary organ (Paragraph [0248]), inserting an implantable constriction device into the body of the patient (Paragraph [0250]), and placing the implantable constriction device in connection with the luminary organ (Paragraphs [0250]-[0252), such that the implantable constriction device can constrict the luminary organ to restrict a flow of fluid therethrough (Paragraphs [0250]-[0252) wherein the implantable constriction device comprises an operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ (Figure 219 “101”), a hydraulic reservoir for holding a hydraulic fluid (Figure 219 “115”), a hydraulic pump for pumping fluid from the hydraulic reservoir to the operable hydraulic constriction element (Figure 219 “105”), an injection port for injecting and removing hydraulic fluid from the implantable constriction device, when implanted (Figure 219 “110”), and an injection port conduit creating a fluid connection between the injection port and the operable hydraulic constriction element (Figure 219), such that hydraulic fluid can be removed from the operable hydraulic constriction element through the injection port (Paragraph [4335]).
Forsell discloses a fluid connection between the injection port and the operable hydraulic constriction element, but fails to disclose an injection port conduit creating a direct fluid between the injection port and the operable hydraulic constriction element. Forsell ‘206 discloses a direct connection of the injection port to the operable hydraulic constriction element (Paragraphs [0029], [0066], [0105], [0271], [0744]) as an alternative to the fluid connection to the reservoir disclosed by Forsell. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Forsell, with an implantable constriction device comprising an injection port conduit creating a direct fluid connection between the injection port and the operable hydraulic constriction element as taught by Forsell ‘206, since such a modification would provide the predictable results of allowing a practitioner to directly calibrate the fluid level in a hydraulic system of the operable implant, such as the fluid level in the hydraulically operable body engaging portion (Forsell ‘206, Paragraph [0744]).
Regarding claim 7, modified Forsell further discloses the step of inserting an implantable constriction device into the body of the patient comprises inserting the implantable constriction device further an electrode arrangement configured to be arranged between the implantable constriction device and the luminary organ and to engage and electrically stimulate muscle tissue of the luminary organ to exercise the muscle tissue to improve the conditions for long term implantation of the implantable constriction device (Figure 41, Paragraph [3695], constriction/stimulation unit “110” wherein Forsell discloses the unit comprises electrodes in Figures 6A-6C, electrical elements “11a”, “11b”, “11c”).
Regarding claim 12, modified Forsell further discloses the step of inserting the implantable constriction device into the body of the patient of comprises inserting the implantable constriction device comprising the operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ (Figure 41, Paragraph [3695]), the hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element (Figure 41, Paragraph [3695]), an implantable energy storage unit (Paragraphs [0230]-[0233]), and a capacitor connected to the implantable energy storage unit and connected to the hydraulic pump (Paragraph [0230]-[0233]), wherein the capacitor is configured to be charged by the implantable energy storage unit and to provide the hydraulic pump with electrical power (Paragraph [0230]-[0233]).
Regarding claim 13, modified Forsell further discloses the step of inserting the implantable constriction device into the body of the patient of comprises inserting an implantable constriction device comprising the operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ (Figure 41, Paragraph [3695]), the hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element (Figure 41, Paragraph [3695]), a controller configured to control the hydraulic pump (Paragraph [3727]), the controller comprising a sensor adapted to detect a magnetic field (Paragraph [3726] and [1940] ) and a processing unit having a sleep mode and an active mode (Paragraph [3727]), an external control unit adapted to be arranged outside of the patient's body, the external control unit comprising a first coil adapted to create a magnetic field detectable by an internal sensor (Paragraphs [1940] and [0298]), wherein the controller is further configured to, in response to a detected magnetic field exceeding a predetermined value, setting the processing unit in an active mode (Paragraph [3726]-[3727]).
Regarding claim 14, modified Forsell further discloses the step of placing the implantable constriction device in connection with the luminary organ comprises placing the implantable constriction device around the luminary organ of the patient (Paragraph [4025], Figure 127B).
Regarding claim 16, modified Forsell further discloses the step of placing the implantable constriction device in connection with the luminary organ comprises securing the implantable constriction device by means of at least one of sutures or staples (Paragraph [3170]).
Regarding claim 17, modified Forsell further discloses the step of inserting the implantable constriction device into the body of the patient comprises inserting an implantable controller into the body of the patient and fixating the implantable controller to tissue or bone in the body of the patient (Paragraph [3907], Figure 90B).
Regarding claim 18, modified Forsell further discloses the step of inserting the implantable constriction device into the body of the patient comprises inserting an operation device (Paragraph [3886], Figure 79) comprising at least one of: the implantable hydraulic pump (Paragraph [3886], Figure 79) and an implantable valve (Paragraph [3886], Figure 79) and fixating the implantable operation device to tissue or bone in the body of the patient (Figure 75).
Regarding claim 20, modified Forsell further discloses fixating the injection subcutaneously (Figure 90B, Paragraph [3908]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) in view of Forsell (US20190111206A1) and further in view of Tenney (EP0093507B1).
Regarding claim 2, Forsell, as modified by Forsell ‘206, discloses the method according to claim 1, wherein the step of inserting an implantable constriction device into the body of the patient comprises inserting the implantable constriction device comprising a first, second and third luminary organ contacting element (Paragraph [3640], Figures 6A-6C), wherein: the first luminary organ contacting element comprises a first operable hydraulic constriction element configured to be inflated to constrict the luminary organ for restricting the flow of fluid therethrough (Paragraph [3640], Figures 6A-6C), the second luminary organ contacting element comprises a second operable hydraulic constriction element configured to be inflated (Paragraph [3640], Figures 6A-6C), and the third luminary organ contacting element comprises at least one cushioning element configured to contact the luminary organ (Paragraph [3640], Figures 6A-6C).
Modified Forsell does not explicitly disclose a second operable hydraulic constriction element configured to be inflated to assist in releasing the constriction of the luminary organ for restoring the flow of fluid therethrough. Tenney discloses a prosthetic occlusive device for occluding an internal passageway of the human body (Abstract), wherein the device comprises a first and second cuff chamber (Col 4, lines 33-58, Figures 4a-5c), where in the first cuff chamber is inflated to constrict the passageway and the second is inflated to assist in releasing the constriction of the luminary organ for restoring the flow of fluid therethrough (Figures 4b and 5b specifically. The cuff chamber is inflated partially to control the flow of fluid, but not fully release it, Col 4, lines 33-58). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell, with the second operable hydraulic constriction element configured to be inflated to assist in releasing the constriction of the luminary organ for restoring the flow of fluid as taught by Tenney, since such a modification would provide the predictable results of allowing a user the ability to control the flow of fluid (Col 4, lines 33-58).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1), further referred to as Forsell ‘254, in view of Forsell (US20190111206A1), further referred to as Forsell ‘206, and further in view of Forsell (WO2014140282A1), further referred to as Forsell ‘282.
Regarding claim 5, Forsell ‘254, as modified by Forsell ‘206, discloses the method according to claim 1, wherein the step of inserting an implantable constriction device into the body of the patient comprises inserting the implantable constriction device comprising the first operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ in a first direction to constrict a first portion of the luminary organ for restricting the flow of fluid therethrough (Paragraph [3640], Figures 6A-6C), a second operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ in a second direction to constrict the first portion of the luminary organ for restricting the flow of fluid therethrough (Paragraph [3640], Figures 6A-6C), and a first hydraulic system in fluid connection with the first operable hydraulic constriction element (Paragraph [0202]).
Modified Forsell ‘254 does not disclose a second hydraulic system in fluid connection with the second operable hydraulic constriction element, wherein the first and second operable hydraulic constriction elements are adjustable independently from each other. Forsell ‘282 discloses an operable implant adapted to be implanted in the body of a patient (Abstract) specifically a body engaging portion adapted to constrict a luminary organ (Figure 45b). Forsell ‘282 discloses a first and second body engaging portions where in the first and second body engaging portions connected to first and second hydraulic pump, respectively, in order to control each of the first and second body engaging portions independently (Figure 45b, Paragraph [000760]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with a second hydraulic system in fluid connection with the second operable hydraulic constriction element, wherein the first and second operable hydraulic constriction elements are adjustable independently from each other as taught by Forsell ‘282, since such a modification would provide the predictable results of reducing the strain on the luminary organ (Forsell ‘282, Paragraph [000760]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1), in view of Forsell (US20190111206A1) and further in view of Hassler (US20060211914A1).
Regarding claim 9, Forsell ‘254, as modified by Forsell ‘206, discloses the method according to claim 1, wherein the step of inserting the implantable constriction device into the body of the patient comprises inserting an implantable constriction device comprising the operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ (Paragraph [4269]), a pressure sensor configured to sense the pressure (Paragraph [3968]), the hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element (Paragraph [4269]), and a controller configured to receive pressure sensor input from the pressure sensor and control the hydraulic pump on the basis of the received pressure sensor input (Paragraph [3968]).
Modified Forsell ‘254 does not disclose a pressure sensor configured to sense the pressure in the operable hydraulic constriction element, wherein the pressure sensor comprises a diaphragm, and wherein the diaphragm is in fluid connection with the hydraulic fluid in the operable hydraulic constriction element, and connected to a pressure sensing element of the pressure sensor, such that the pressure sensing element is separated from the hydraulic fluid in the operable hydraulic constriction element by the diaphragm. Hassler discloses a pressure sensing system to measure the fluid pressure within the closed hydraulic circuit of an implanted portion (Paragraphs [0058]-[0060]). Hassler further discloses the pressure sensor configured to sense the pressure in the operable hydraulic constriction element (Paragraphs [0058]-[0060]), wherein the pressure sensor comprises a diaphragm (Paragraphs [0058]-[0060]), and wherein the diaphragm is in fluid connection with the hydraulic fluid in the operable hydraulic constriction element (Paragraphs [0058]-[0060]), and connected to a pressure sensing element of the pressure sensor (Paragraphs [0058]-[0060]), such that the pressure sensing element is separated from the hydraulic fluid in the operable hydraulic constriction element by the diaphragm (Paragraphs [0058]-[0060]). If a POSITA was looking to sense the pressure in the hydraulic constriction device, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with a pressure sensor configured to sense the pressure in the operable hydraulic constriction element, wherein the pressure sensor comprises a diaphragm, and wherein the diaphragm is in fluid connection with the hydraulic fluid in the operable hydraulic constriction element, and connected to a pressure sensing element of the pressure sensor, such that the pressure sensing element is separated from the hydraulic fluid in the operable hydraulic constriction element by the diaphragm as taught by Hassler, since such a modification would provide the predictable results of allowing the sensor to hermetically sealed to prevent the fluid from affecting the operation of the sensor (Hassler, Paragraph [0059]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) in view of Forsell (US20190111206A1) and further in view of Forsell (US20160074196A1), further referred to as Forsell ‘196.
Forsell ‘254, as modified by Forsell ‘206, discloses the method according to claim 1, wherein the step of inserting an implantable constriction device into the body of the patient comprises inserting an implantable constriction device comprising the operable hydraulic constriction element configured to be inflated to exert a pressure on the luminary organ (Fig. 74A), the hydraulic pump for pumping a hydraulic fluid to the operable hydraulic constriction element (Paragraph [3858]), wherein the hydraulic pump comprises a compressible reservoir configured to hold a hydraulic fluid to be moved to the operable hydraulic constriction element (Paragraph [3858]).
Modified Forsell ‘254 does not disclose a motor comprising a shaft, wherein the motor is configured to generate force in a radial direction by rotation of the shaft, a transmission configured to transfer the force in the radial direction to a force substantially in an axial direction of the shaft for compressing the compressible reservoir, and at least one bearing for the shaft, wherein the bearing is configured to withhold at least half of the force in the axial direction, for reducing the axial load on at least one of the motor and a gear system, caused by the compression of the reservoir. Forsell ‘196 discloses a hydraulic implantable restriction device for restricting a luminary organ of a patient (Abstract) wherein the implantable constriction device comprises a motor comprising a shaft (Paragraphs [0363]-[0367] and figure 22), wherein the motor is configured to generate force in a radial direction by rotation of the shaft (Paragraphs [0363]-[0367] and figure 22), a transmission configured to transfer the force in the radial direction to a force substantially in an axial direction of the shaft for compressing the compressible reservoir (Paragraphs [0363]-[0367] and figure 22), and at least one bearing for the shaft (Paragraphs [0363]-[0367] and figure 22), wherein the bearing is configured to withhold at least half of the force in the axial direction, for reducing the axial load on at least one of the motor and a gear system (Paragraphs [0363]-[0367] and figure 22. Paragraph [0366] recites “makes it possible to optimize the motor, seals and bearings for a particular rotational direction”), caused by the compression of the reservoir (Paragraphs [0363]-[0367] and figure 22). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with a motor comprising a shaft, wherein the motor is configured to generate force in a radial direction by rotation of the shaft, a transmission configured to transfer the force in the radial direction to a force substantially in an axial direction of the shaft for compressing the compressible reservoir, and at least one bearing for the shaft, wherein the bearing is configured to withhold at least half of the force in the axial direction, for reducing the axial load on at least one of the motor and a gear system, caused by the compression of the reservoir as taught by Forsell ‘196, since such a modification would provide the predictable results of facilitating the control and optimization of the motor (Forsell ‘196, Paragraph [0366]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) in view of Forsell (US20190111206A1) and further in view of Chechik (US20130261386A1).
Regarding claim 11, Forsell ‘254 as modified by Forsell ‘206, discloses the method according to claim 1, wherein the step of inserting the implantable constriction device into the body of the patient comprises inserting an implantable constriction device comprising the operable hydraulic constriction element comprising a contacting wall portion configured to engage the luminary organ for exerting force thereon (See annotated figure 6B below), a withholding wall portion configured to be connected to a withholding structure for withholding the force exerted on the luminary organ (See annotated figure 6B), such that the luminary organ is constricted, a connecting wall portion organ (See annotated figure 6B), connecting the contacting wall portion to the withholding wall portion organ (See annotated figure 6B), wherein and a first portion of the connecting wall portion is connected to the contacting wall portion organ (See annotated figure 6B), a second portion of the connecting wall portion is connected to the withholding wall portion organ (See annotated figure 6B).
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Modified Forsell ‘254 does not disclose that the first portion of the connecting wall portion being more resilient than the second portion of the connecting wall portion. Chechik discloses an artificial urinary sphincter system that includes a cuff implantable around a portion of a urethra and an implantable pressure-regulating reservoir (Abstract). The pressure regulating reservoir consists of polymer with two different material properties, one hard and one more flexible for the purpose of allowing pressure-regulation (Paragraph [0041]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with the first portion of the connecting wall portion being more resilient than the second portion of the connecting wall portion as taught by Chechik, since such a modification would provide the predictable results of allowing the device to provide pressure relief should the pressure on the lumen become too high.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) in view of Forsell (US20190111206A1) and further in view of Burton (US4222377A).
Regarding claim 15, Forsell ‘254, as modified by Forsell ‘206, discloses the method according to claim 1, but does not disclose the step of placing the implantable constriction device in connection with the luminary organ comprises closing a locking or fixation device of the implantable constriction device around the luminary organ to fixate the implantable constriction device to the luminary organ of the patient. Burton discloses a pressure-regulated artificial sphincter apparatus for controlling vesicular incontinence (Abstract) wherein the cuff “12c” is folded around a vessel “126” and fastened thereto by tying cuff ends “128” and “” together with a plurality of sutures “130” (Figure 7). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with the step of placing the implantable constriction device in connection with the luminary organ comprises closing a locking or fixation device of the implantable constriction device around the luminary organ to fixate the implantable constriction device to the luminary organ of the patient as taught by Burton, since such a modification would provide the predictable results of a common method for closing artificial sphincter apparatuses.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US20110066254A1) in view of Forsell (US20190111206A1) and further in view of Longhini (US20090043356A1).
Regarding claim 23, Forsell ‘254, as modified by Forsell ‘206, discloses the method of claim 1 but does not disclose testing electrical stimulation of the tissue of the luminary organ. Longhini discloses an electrode sling for treating incontinence (Abstract) wherein the electrical stimulation of the tissue is applied intermittently to confirm electrode alignment and that the energy source is operational (Paragraph [0041]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Forsell ‘254, with testing electrical stimulation of the tissue of the luminary organ as taught by Longhini, since such a modification would provide the predictable results of confirming proper function of the electrodes.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 9-18, 20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4-13, 15, and 18 of U.S. Patent No. 12,350,138. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claims broader subject matter. Claim 1 of the instant application is directed to a luminary organ while claim 1 of 12,350,138 is directed to a urethra.
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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791