DETAILED ACTION
Response to Amendment
The amendment filed October 8, 2025. Claims 1, 3-7, 10, and 15-20 have been amended, claims 8-9 have been cancelled, and claims 21-22 have been newly added. Claims 1-7 and 10-22 are currently pending in the application.
Response to Arguments
Applicant's arguments filed October 8, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Neuwirth fails to disclose the ability of the device to pass an ablative agent into the cavity along with the simultaneous evacuation of air, the Examiner respectfully disagrees. 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. The same reasoning is applicable to amended claim 5, the prior art is not required to explicitly teach the agent being infused along with the evacuation of air, but need only teach two catheters wherein one of the catheters can perform an infusion, and where the other catheter can evacuate the cavity at the same time (e.g., two separate lumens, a positive pressure pump, a negative pressure pump, and some disclosure of the pumps running concurrently is sufficient). Regarding new claim 21, the term “balancing” is not substantially limiting to an equal pressure being applied to each channel. Even a ratio of flow between the inflow lumen and outflow lumen is considered to be “balancing” the pressure gradient within the cavity. If Applicant wishes to claim equal pressure being applied by both pumps it should be explicitly claimed as such. Neuwirth discloses balancing the fluid flow during washing so as to not exceed the fallopian tube opening pressure or to collapse the uterine cavity (Col. 7, lines 51-54 and Col. 8, lines 19-22). Circulating gas via inflow and outflow lumens is considered to be “balancing” the fluid flow through the cavity as claimed.
Regarding Applicant’s arguments directed to claim 16, the Examiner agrees that the amendment to require the therapeutic agent to enhance tissue contact of the ablative agent overcomes the current rejection and the rejection is therefore withdrawn. A new grounds of rejection is set forth below with respect to the method claims.
Claim Objections
Claim 16 is objected to because of the following informalities: there is an extra semi-colon in line 9 of claim 16 which should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7, 10-15, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The amendment to claim 5 sets forth “wherein the apparatus is configured to inject an ablative agent….” It is unclear whether this ablative agent is separate and distinct from “the ablative agent” set forth previously. The claim will be examined as if the apparatus is configured to inject “the ablative agent directly into the cavity….” Claims 6-7, 10-15, and 21 are rejected due to their dependence from claim 5.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-18 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McIntyre (US 2007/0038203).
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).
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 18, McIntyre further discloses the steps of leaving the therapeutic ablative agent in the cavity for a preset period of time after injection into the cavity (¶ [0014] as above discloses a duration of treatment); and after the pre-set period of time, evacuating the therapeutic ablative agent from the body cavity (¶ [0022] discloses that after treatment, the medium is flushed from the cavity).
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).
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, 10-15, and 21 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) 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 (through catheter 2) 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); and a second passage for aspirating the agent from the cavity (through catheter 3; Col. 8, lines 8-10); 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).
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]).
Regarding claim 21, Neuwirth further discloses balancing the passage of the ablative agent into the cavity and evacuation of air from the cavity (Col. 8, lines 23-32 disclose the circulating washing step of infusion/aspiration of the cavity to remove the silver nitrate; therefore the device of Neuwirth is designed for balanced infusion/aspiration of the cavity and comprises the structure of performing such a method as set forth above; the combined irrigation/aspiration is considered “balanced” as claimed as any ratio of infusion/aspiration pressure is considered balancing of the flow; the claim fails to require equal pressures to be applied).
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) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Truckai.
Regarding claim 19, McIntyre discloses 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, 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, 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
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.
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.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783