DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
Examiner contacted Attorney Leanne Flatter on Wednesday April 8, 2026 and left a voicemail and on Monday April 13, 2026 through email for the purposes of compact prosecution regarding the filing of an E-terminal disclaimer to overcome the double patenting rejections and put the case in condition for allowance. Examiner has not received a reply to either attempt to contact the attorney.
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9662060 in view of Sharma (US 2010/0094270).
Although the claims at issue are not identical, they are not patentably distinct from each other because see chart below. Further Examiner notes the conflicting patent is merely the method of performing a procedure using the device of the instant application. The instant application merely further discloses the structures of said uterine ablation device. Sharma teaches these structures as shown in at least Paragraphs 0108-0111 among the full disclosure. And it would have been obvious to one of ordinary skill in the art to have modified the Patent with Sharma because it allows for a device that provides a consistent, controlled, and uniform ablation of the target tissue, and for minimizing the adverse side effects of the ablation (Paragraph 0013 of Sharma).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11849991 in view of Sharma (US 2010/0094270).
Although the claims at issue are not identical, they are not patentably distinct from each other because see chart below. Further Examiner notes the conflicting patent is merely the method of performing a procedure using the device of the instant application. The instant application merely further discloses the structures of said uterine ablation device. Sharma teaches these structures as shown in at least Paragraphs 0108-0111 among the full disclosure. And it would have been obvious to one of ordinary skill in the art to have modified the Patent with Sharma because it allows for a device that provides a consistent, controlled, and uniform ablation of the target tissue, and for minimizing the adverse side effects of the ablation (Paragraph 0013 of Sharma).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10179019 in view of Sharma (US 2010/0094270).
Although the claims at issue are not identical, they are not patentably distinct from each other because see chart below. Further Examiner notes the conflicting patent is merely the method of performing a procedure using the device of the instant application. The instant application merely further discloses the structures of said uterine ablation device. Sharma teaches these structures as shown in at least Paragraphs 0108-0111 among the full disclosure. And it would have been obvious to one of ordinary skill in the art to have modified the Patent with Sharma because it allows for a device that provides a consistent, controlled, and uniform ablation of the target tissue, and for minimizing the adverse side effects of the ablation (Paragraph 0013 of Sharma).
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11219479.
Although the claims at issue are not identical, they are not patentably distinct from each other because see chart below. The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the rejected claims are anticipated by the patented claims, it is not patentably distinct from the patented claims.
Instant Application 18/389,410
Conflicting US Patent No. 9662060
Conflicting US Patent No. 11849991
2. A uterine ablation device, comprising:
a shaft;
an inflow lumen disposed along a length of the shaft;
an outflow lumen disposed along the length of the shaft;
a controller configured to perform operations comprising:
delivering fluid or gas from the inflow lumen of the uterine ablation device into a uterus of a patient when the shaft is disposed in the uterus of the patient;
while delivering the fluid or the gas from the inflow lumen:
removing some of the gas or the fluid through the outflow lumen of the uterine ablation device; and
measuring a flow rate of the fluid or the gas flowing through the inflow lumen; and
in response to detecting that the flow rate of the fluid or the gas flowing through the inflow lumen is above a patency flow rate threshold value while removing some of the gas or the fluid through the outflow lumen, determining that the uterine ablation device is not clogged or embedded in tissue.
1. A method of performing a procedure on a uterus of a patient, comprising:
performing a uterine integrity test comprising: inserting a uterine device into the uterus of the patient;
delivering gas or fluid from an inflow lumen of the uterine device into the uterus;
measuring a flow rate of the gas or fluid as it is delivered into the uterus;
determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value;
eliminating retrograde flow from the uterus back through the uterine device with a one way valve disposed in the inflow lumen; and
after performing the uterine integrity test and determining that the uterus is sealed, performing a patency test for the uterine device comprising:
delivering gas or fluid from the inflow lumen of the uterine device into the uterus;
removing gas or fluid from the uterus with an outflow lumen of the uterine device;
determining that the uterine device is not clogged or embedded in tissue if a flow rate of gas or fluid removed from the uterus is observed through the outflow lumen of the uterine device.
2. The method of claim 1 wherein the uterine device is a uterine ablation device.
1. A method of performing a procedure on a uterus of a patient, the method comprising:
inserting a uterine ablation device into the uterus of the patient;
delivering fluid or gas from an inflow lumen of the uterine ablation device into the uterus;
while delivering the fluid or the gas from the inflow lumen: removing some of the gas or the fluid through an outflow lumen of the uterine ablation device; and
measuring a flow rate of the fluid or the gas flowing through the inflow lumen; and in response to detecting that the flow rate of the fluid or the gas flowing through the inflow lumen is above a patency flow rate threshold value while removing some of the gas or the fluid through the outflow lumen, determining that the uterine ablation device is not clogged or embedded in tissue.
2. A uterine ablation device, comprising:
a shaft;
an inflow lumen disposed along a length of the shaft;
an outflow lumen disposed along the length of the shaft;
a controller configured to perform operations comprising:
delivering fluid or gas from the inflow lumen of the uterine ablation device into a uterus of a patient when the shaft is disposed in the uterus of the patient;
while delivering the fluid or the gas from the inflow lumen:
removing some of the gas or the fluid through the outflow lumen of the uterine ablation device; and
measuring a flow rate of the fluid or the gas flowing through the inflow lumen; and
in response to detecting that the flow rate of the fluid or the gas flowing through the inflow lumen is above a patency flow rate threshold value while removing some of the gas or the fluid through the outflow lumen, determining that the uterine ablation device is not clogged or embedded in tissue.
27. A method of performing a procedure on a uterus of a patient, comprising: inserting a uterine ablation device into the uterus of the patient; delivering fluid from an inflow lumen of the uterine ablation device into the uterus; measuring a flow rate of the fluid as it is delivered into the uterus;
distending the uterus with the delivered fluid;
determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value; eliminating retrograde flow caused by uterine contractions from flowing back through the inflow lumen with a one way valve disposed in the inflow lumen;
determining that the uterine ablation device is not clogged or embedded in tissue if a return flow of fluid is observed through an outflow lumen of the uterine ablation device; treating the uterus of the patient without reducing distension pressure with the uterine ablation device immediately following the step of determining that the uterine ablation device is not clogged and the uterus is sealed.
2. A uterine ablation device, comprising:
a shaft;
an inflow lumen disposed along a length of the shaft;
an outflow lumen disposed along the length of the shaft;
a controller configured to perform operations comprising:
delivering fluid or gas from the inflow lumen of the uterine ablation device into a uterus of a patient when the shaft is disposed in the uterus of the patient;
while delivering the fluid or the gas from the inflow lumen:
removing some of the gas or the fluid through the outflow lumen of the uterine ablation device; and
measuring a flow rate of the fluid or the gas flowing through the inflow lumen; and
in response to detecting that the flow rate of the fluid or the gas flowing through the inflow lumen is above a patency flow rate threshold value while removing some of the gas or the fluid through the outflow lumen, determining that the uterine ablation device is not clogged or embedded in tissue.
28. A method of performing a procedure on a uterus of a patient, comprising:
inserting a uterine ablation device into the uterus of the patient;
delivering fluid from an inflow lumen of the uterine ablation device into the uterus;
measuring a flow rate of the fluid as it is delivered into the uterus;
distending the uterus with the flow of fluid;
determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value; eliminating retrograde flow caused by uterine contractions from flowing back through the inflow lumen with a one way valve disposed in the inflow lumen;
determining that the uterine ablation device is not clogged or embedded in tissue if a return flow of fluid is observed through the outflow lumen of the uterine ablation device; and treating the uterus of the patient with the uterine ablation device immediately following the step of determining that the uterine ablation device is not clogged and the uterus is sealed without reducing distension pressure in the uterus of the patient.
Instant Application 18/389,410
Conflicting US Patent No. 10179019
Conflicting US Patent No. 11219479
2. A uterine ablation device, comprising:
a shaft;
an inflow lumen disposed along a length of the shaft;
an outflow lumen disposed along the length of the shaft;
a controller configured to perform operations comprising:
delivering fluid or gas from the inflow lumen of the uterine ablation device into a uterus of a patient when the shaft is disposed in the uterus of the patient;
while delivering the fluid or the gas from the inflow lumen:
removing some of the gas or the fluid through the outflow lumen of the uterine ablation device; and
measuring a flow rate of the fluid or the gas flowing through the inflow lumen; and
in response to detecting that the flow rate of the fluid or the gas flowing through the inflow lumen is above a patency flow rate threshold value while removing some of the gas or the fluid through the outflow lumen, determining that the uterine ablation device is not clogged or embedded in tissue.
1. A method of performing a patency test for a uterine ablation device, comprising:
inserting the uterine ablation device into a uterus of a patient;
closing an outflow valve to seal an outflow lumen of the uterine ablation device;
delivering gas or fluid from an inflow lumen of the uterine ablation device into the uterus to achieve uterine cavity distension;
opening the outflow valve only partially to remove gas or fluid from the uterus with the outflow lumen of the uterine ablation device while maintaining uterine cavity distension;
determining a flow rate of gas or fluid in the outflow lumen while the outflow lumen is only partially opened;
comparing the flow rate of gas or fluid in the outflow lumen to a threshold value; and
determining that the uterine ablation device is not clogged or embedded in tissue if the flow rate of gas or fluid is above the threshold value.
1. A uterine ablation device, comprising:
a shaft adapted to be inserted into a uterus of a patient, the shaft including an outflow lumen and an inflow lumen;
a source configured to deliver gas or fluid through the inflow lumen of the shaft into the uterus;
an outflow valve configured to seal the outflow lumen of the shaft;
a flow meter that is fluidly coupled to the inflow lumen and configured to measure a flow rate of gas or fluid as it is delivered into the uterus; and
an electronic controller operatively coupled to the source, the outflow valve, and the flow meter, the electronic controller being configured to:
open the outflow valve only partially to remove gas or fluid from the uterus through the outflow lumen of the uterine ablation device while maintaining distension of a cavity of the uterus;
determine a flow rate of gas or fluid in the outflow lumen while the outflow valve is only partially opened and distension of the cavity of the uterus is maintained; and
determine that the uterine ablation device is not clogged or embedded in tissue if the flow rate of gas or fluid is above a threshold value.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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