DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 21, 2026 has been entered.
Response to Arguments
Applicant's arguments filed June 21, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments as to the simultaneous delivery and evacuation of air from the cavity, the Examiner maintains that Neuwirth teaches such a feature as set forth in the response to arguments in the final rejection mailed February 27, 2026. Neuwirth teaches a first channel for delivery of a therapeutic agent and a second channel for evacuation of the cavity (Col. 8, lines 23-32 disclose simultaneous washing of the cavity and evacuation through catheters 2 and 3). Neuwirth discloses in the same citation wherein the delivery of a solution and evacuation of the cavity are performed simultaneously. Therefore, Neuwirth discloses a device comprising the required structure, and the function of its use such as is disclosed in claim 1. The device need only be capable of performing the claimed function and because the suction channel of Neuwirth is disclosed for removing fluid from within the channel which includes a paste, it is fully capable of removing air from within the channel during such an evacuation if present. Similarly, the infusion catheter is fully capable of infusing a therapeutic agent into the cavity during the washing step (e.g., sodium chloride is infused to neutralize the silver nitrate within the cavity). This is disclosed as happening simultaneously to the evacuation of the fluid from the cavity. The device claims are not being interpreted in a manner which requires the explicit method of use of the device but only its structure and capability of being used in the claimed manner. Because Neuwirth discloses the claimed structure which is fully capable of performing the claimed function, it is considered to meet the claim limitation as currently set forth. The rejection, with respect to the device claims, is considered proper and is maintained. Regarding Applicant’s arguments with respect to amended claim 16, the Examiner agrees and a new grounds of rejection is set forth below.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 4-7, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neuwirth (US 5,891,457) in view of Truckai et al. (US 2012/0232545).
Regarding claim 1, Neuwirth discloses (Figure 1) an apparatus for delivering a therapeutic ablative agent (7) to a uterine cavity (4; Col. 4, line 66-Col. 5, line 14) of a patient comprising: a) an elongated member (hysteroscope 1) having a first channel (through catheter 2) for passage of the ablative agent into the uterine cavity of the patient for endometrial ablation (Col. 7, lines 3-6) and a second channel (catheter 3), the first channel having a distal opening and the agent injected at controlled pressure through the distal opening and directly into the uterine cavity (Figure 1; catheter 2 is used to deploy the caustic paste 7 and to provide an infusion solution 8) , the second channel (catheter 3) configured to evacuate air during passage of the ablative agent through the first channel such that injection of the ablative agent is simultaneous with evacuation of air (the device is fully capable of performing an evacuation through catheter 3 while an infusion is being performed with catheter 2; Col. 7, lines 33-36 disclose the evacuation of gas through catheter 3 and Col. 8, lines 23-27 disclose the simultaneous infusion and aspiration of the cavity); c) a control (e.g., Col. 4, lines 50-65 disclose a control means connected to the catheter for adjusting procedure parameters) to i) set flow parameters for evacuation to exceed flow parameters for passage of the ablative agent to purge the cavity of the ablative agent and ii) set flow parameters for passage of the ablative agent to exceed flow parameters for evacuation to provide evacuation while the ablative agent is passed into the cavity (Col. 4, lines 50-65; the control as claimed is not specific to any actual structure and is being interpreted in the broadest reasonable manner; the control system of Neuwirth controls all of the procedure parameters during use and is therefore fully capable of functioning in the claimed manner wherein the catheter is disclosed as allowing for any simultaneous infusion/aspiration of the cavity during the procedure);; d) wherein the therapeutic ablative agent is received from an ablative agent source for passage from a proximal entry of the first channel into and through the first channel (Col. 6, lines 27-35 disclose the caustic paste as being delivered through the proximal end 5 of the device 1); Neuwirth further discloses an expanding member (Col. 6, lines 24-27), but fails to disclose the expanding member extending distally of the elongated member, the expanding member having a first condition for delivery and a second expanded condition for placement within the cavity, the expanding member having a plurality of perforations to provide a plurality of entrance openings for passage therein during aspiration of the cavity.
Truckai et al. (henceforth Truckai) teaches (Figures 2 and 5) a system for uterine ablation comprising an expanding member (122) extending distally of an elongated member (110) having a first condition for delivery (e.g., Figure 1 depicts member 122 within the elongated member 110 prior to deployment; ¶ [0053]) and a second expanded condition (Figures 2 and 5) for placement within the cavity, the expanding member having a plurality of perforations (apertures 202) to provide a plurality of entrance openings for passage therein during aspiration of the cavity (see ¶ [0060] which discloses the openings as being used for fluid inflow and outflow during a procedure; see also ¶ [0017] which discloses the flow medium for infusion into the uterine cavity as a liquid).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal end of catheter treatment device of Neuwirth to comprise the expandable member flow assembly of Truckai (resulting structure of modification would show the distal assembly of Truckai added onto the distal end of catheter 1 of Neuwirth to include the expandable member; it is further noted that the expandable member is not required by the claim to open into the uterine cavity for direct interaction with the tissue therein, but only requires the expandable member to be in the cavity) so as to allow for a device which substantially fills the uterine cavity during a treatment procedure while avoiding undesirable pain or spasms and ensures proper delivery and removal of therapeutic substances therein as taught by Truckai (e.g., ¶¶ [0055] and [0056]).
Regarding claim 2, Truckai further teaches wherein the expanding member comprises a tubular structure forming a loop distal of the elongated member in the second condition (see Figure 5, the expandable arms sections 166a, 166b, 158a, and 158b form loops at the distal end as claimed).
Regarding claims 4 and 7, Neuwirth further discloses evacuating air prior to injection of the agent (the structure of the device of Neuwirth is fully capable of evacuating air through catheter 3 at any point; the claim is reciting an intended use of the device and it is fully capable of performing this function as the aspiration source is provided through catheter 3).
Regarding claim 5, Neuwirth discloses an apparatus for delivering an ablative agent to a body cavity of a patient comprising: a) a first passage chemical ablative agent passage (through catheter 2) in the apparatus configured for passage of the ablative agent (7) into the cavity of the patient (Col. 4, line 66-Col. 5, line 14); the first passage having an opening (open end of catheter 2) to the cavity for exit of the agent into direct contact with the cavity (Figure 1) to chemically ablate tissue (Col. 4, lines 26-49); and a second air evacuation passage in the apparatus for aspirating the agent from the cavity (through catheter 3; Col. 8, lines 8-10; any air in the cavity will be removed with the wash solution); c) wherein the apparatus is configured to inject an ablative agent directly into the cavity at an increased pressure and is injected simultaneously with aspiration of the cavity (Col. 8, lines 23-32 disclose simultaneous irrigation and aspiration of the cavity; in addition, the claim limitation is reciting an intended use and the device of Neuwirth is considered fully capable of performing the claimed function as it comprises all of the structure of the device and a method of performing said simultaneous functions as claimed); wherein the ablative agent (7) is received from an ablative agent source for passage from a proximal entry into the first passage and through the first passage (Col. 6, lines 27-35 disclose the caustic paste as being delivered through the proximal end of the device 1); d) a control (e.g., Col. 4, lines 50-65 disclose a control means connected to the catheter for adjusting procedure parameters) to i) set flow parameters for evacuation to exceed flow parameters for passage of the ablative agent to purge the cavity of the ablative agent and ii) set flow parameters for passage of the ablative agent to exceed flow parameters for evacuation to provide evacuation while the ablative agent is passed into the cavity (Col. 4, lines 50-65; the control as claimed is not specific to any actual structure and is being interpreted in the broadest reasonable manner; the control system of Neuwirth controls all of the procedure parameters during use and is therefore fully capable of functioning in the claimed manner wherein the catheter is disclosed as allowing for any simultaneous infusion/aspiration of the cavity during the procedure); e) wherein the therapeutic ablative agent is received from an ablative agent source for passage from a proximal entry of the first channel into and through the first channel (Col. 6, lines 27-35 disclose the caustic paste as being delivered through the proximal end 5 of the device 1).
Regarding claim 6, Neuwirth/Truckai teach, in the combined device, wherein the first passage (e.g., modified catheter 2) has a plurality of perforations (openings 202 of Truckai) to provide a plurality of entrance openings for passage of the agent into the apparatus (the combined device has a number of inflow and outflow openings along the expandable member, any of which might be used to infuse or aspirate an agent as claimed).
Regarding claim 10, Neuwirth/Truckai discloses the apparatus wherein a fluid is injected into the cavity prior to injection of the agent to assess the presence or absence of leakage out of the cavity, and the agent is injected at a pressure less than or equal to the pressure of injection of the fluid (¶ [0009] of Truckai; also ¶ [0087] discloses flowing gas as 0.85 psi for the test and ¶ [0088] discloses flowing gas at 0.50 psi for treatment). It is further noted that the claim is again reciting an intended use of the device and the structure for performing such a function is known from Neuwirth and it is therefore fully capable of being used to perform such a function as claimed.
Regarding claim 11, Neuwirth further discloses wherein the fluid is injected through the first passage (see Figure 1, catheter 2 is used to inject fluid 8 into the cavity and is therefore fully capable of injecting a fluid for testing uterine integrity as claimed).
Regarding claim 12, Neuwirth further discloses wherein the fluid has one or both of a surface tension less than a surface tension of the agent and a viscosity less than a viscosity of the agent (the device is fully capable of infusing any fluid as set forth above, however, Neuwirth discloses the ablative agent as a caustic paste 7; Col. 4, lines 14-21; and further discloses the fluid as a silver nitrate wash comprising a portion of saline; see Col. 5, lines 48-52).
Regarding claims 13 and 14, Neuwirth is silent regarding a line connectable to a module, the module controlling a time period of injection of the agent so the agent is injected for a preset period of time.
Truckai further teaches a line connectable to a module (135 may be considered a plurality of modules), the module controlling a time period of injection of the agent so the agent is injected for a preset period of time (see ¶ [0062] which discloses that the control unit controls infusion time as well as pressure parameters such as infusion pressures and fluid flows as per claim 14; see ¶ [0061]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Neuwirth to comprise the control unit of as taught by Truckai so as to provide a means of automatically controlling parameters of a procedure including infusion time.
Regarding claim 15, Neuwirth/Truckai (as modified in claim 14) discloses the injection module (135) automatically transitions to injection of the agent is the absence of a leakage is assessed (Truckai, ¶ [0018]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neuwirth in view of Truckai, and further in view of Peliks (US 2013/0090572).
Regarding claim 3, Neuwirth/Truckai teach the apparatus as set forth above for claim 1 except wherein a fluid is injected into the uterine cavity prior to injection of the agent to assess the presence or absence of leakage in the uterine cavity, and the agent is injected at a pressure less than or equal to the pressure of the injection of the fluid.
Peliks teaches an apparatus for uterine ablation wherein a fluid is injected into the uterine cavity prior to injection of the agent to assess the presence or absence of leakage in the uterine cavity, and the agent is injected at a pressure less than or equal to the pressure of the injection of the fluid (¶ [0065] discloses performing the integrity test at pressures greater than infusion pressure to ensure integrity during treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the apparatus of Neuwirth/Truckai with a uterine integrity test as taught by Peliks to determine the safety of such a procedure prior to conducting the endometrial ablation or other uterine procedure as taught by Peliks.
Claim(s) 16-17 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre (US 2007/0038203) in view of Adams et al. (US 2010/0087798).
Regarding claim 16, McIntyre discloses a method for injecting a therapeutic ablative agent from a device into a cavity of a patient comprising: evacuating the cavity of the patient to remove air (¶ [0017] discloses applying suction at the end of instrument 114 to remove air around the fiber which is within the cavity); and injecting the therapeutic ablative agent (medium 110 comprises particles 112 which are designed to scatter the light entering the medium as per ¶¶ [0019]-[0021]; it is through this uniform scattering that the ablation is performed; in this manner, the particles may be considered therapeutic ablative agents within the medium as they are designed to ensure the ablation procedure targets all tissue evenly) out from a passageway (¶ [0013]; through 114 or similar device) into a cavity of a patient (cavity 118 of the uterus; ¶ [0013]; Figure 1) into direct contact with the endometrium (the diffusive medium fills the uterine cavity to contact all of the tissue therein ¶¶ [0009] and [0021]) under controlled pressure simultaneously with evacuating the air from the cavity such that air is evacuated during passage of the therapeutic ablative agent into the cavity to enhance tissue contact of the ablative agent (¶ [0014] discloses that the diffusive medium may be circulated from a supply reservoir into and out of the uterine cavity; this would include removing any air therein during evacuation; the circulation of the fluid means that the inflow and outflow are happening simultaneously); wherein the therapeutic ablative agent is received from an ablative agent source (e.g., from the supply reservoir as per ¶ [0014]) for passage in a first state (¶ [0013] the diffusive medium is infused into the cavity in the first state comprising a fluid and scattering particles) from a proximal entry of the device into the passageway and through the passageway to enter the cavity of the patient in the first state (¶ [0013], the diffusive medium is introduced into the uterine cavity through instrument 114 or similar via a proximal end connected to the medium source; it enters the uterine cavity in this state). McIntyre discloses the use of a fluid medium which may be considered a chemical substance absent any further definition of what constitutes a “chemical”, however, McIntyre only discloses thermal energy as entering the tissue and not the particles in the fluid which cause the irradiation of the site.
Adams et al. (henceforth Adams) teaches a system for ablating the uterine cavity wherein chemical and electromagnetic means are used to ablate a target tissue (e.g., ¶ [0114] discloses chemical and/or electromagnetic energy being applied to the site to perform the ablation).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the procedure of McIntyre to comprise the step of utilizing a chemical agent along with the electromagnetic radiation means such it is known in endometrial procedures to combine therapies depending on the type of procedure being performed. Such a method allows for precise targeting of the desired tissue via different treatment modalities (e.g., thermal and chemical energies) for arriving at the best possible outcome from the procedure.
Regarding claim 17, McIntyre further discloses wherein the therapeutic ablative agent (medium 110) is injected into the cavity for a pre-set period of time (e.g., ¶ [0014] discloses a “duration of treatment” which implies a pre-set period of time).
Regarding claim 22, McIntyre further discloses balancing the passage of the ablative agent into the cavity and evacuation of air from the cavity (¶ [0014] discloses that the medium is circulated into and out of the cavity during the procedure; this anticipates a “balance” of flow as claimed since the control of the circulation will provide control over the infusion/aspiration of the cavity to achieve such a circulation) to enable one or both of purging of the chemical ablative agent after application to the cavity or filling the cavity while evacuation is operating (¶ [0017] discloses suction of the cavity to remove any fluid therein).
Regarding claim 23, Adams further teaches wherein the chemical ablative agent is trichloroacetic acid (¶ [0257]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Adams, and further in view of Edwards et al. (US 5,558,672).
Regarding claim 18, McIntyre/Adams teach the claimed method substantially as set forth above for claim 16, but do not explicitly disclose the treatment penetrating to the myometrium.
Edwards et al. (henceforth Edwards) teaches a uterine ablation apparatus which is intended to apply energy to the endometrium as well as a portion of the underlying myometrium tissue during an ablation procedure (Col. 6, lines 35-53).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of McIntyre/Adams to include the step of allowing the agent to penetrate the myometrium since it is known in uterine ablation procedures that targeting of a partial depth of the myometrium is advantageous to ensure complete treatment of the tissue during said procedure. This could be achieved by either the heat of the electromagnetic radiation of McIntyre or the use of the trichloroacetic acid chemical agent of Adams which is used in conjunction with the irradiation therapy of McIntyre.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Adams, and further in view of Truckai.
Regarding claim 19, McIntyre/Adams teach the claimed method substantially as set forth above for claim 16, but fails to explicitly disclose the step of checking the integrity of the uterine cavity prior to injection.
Truckai teaches a method of treating the uterine cavity which includes the step of checking the integrity of the cavity to determine if there is leakage from the cavity, wherein if no leakage is determined by checking the integrity of the cavity, injection of an ablative agent is automatically initiated (Figure 14; ¶ [0073] discloses the steps of determining if the cavity is perforated and ¶ [0081] discloses automatically initiating the procedure if the cavity is not perforated).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the uterine cavity treatment method of McIntyre/Adams, to include the step of cavity integrity testing of Truckai, to determine of the uterine cavity is perforated prior to filling the cavity with the diffusion medium of McIntyre. This step provides a means of ensuring that the cavity is suitable for chemical ablation as taught by Truckai (see e.g., ¶ [0009] which discloses that a perforated wall is not suitable for ablation).
Regarding claim 20, Truckai further discloses, wherein if no leakage is determined by checking the integrity of the cavity, a user actuates a valve to open a fluid line for injection of the therapeutic ablative agent (valves 246, 250; Figures 4 and 14; ¶ [0063] discloses that the valves are actuated by the system operator to enable flow).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of McIntyre/Adams, to provide the valve control of Truckai, over the diffusion medium flow so that a user may be assured, after checking the integrity of the cavity as above, that the medium is safe to deliver into the cavity as taught by Truckai.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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, Michael Tsai can be reached at 571-270-5246. 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.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights