DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/8/2024 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-4 and 6-20 is/are rejected under pre-AIA 35 U.S.C. 102 (e) as being anticipated by US 2011/0112433 (Toth).
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
In regards to claims 1, 9, and 15, Toth discloses methods for evaluating integrity of a uterine cavity (title and abstract; figures 5-13; paragraphs 18-66). Toth discloses the following steps:
passing a working end (122) of a medical device through a cervical canal and into a patient's uterine cavity (see figures 5, 6, and 8A-8D and 11; paragraphs 24-32 and 48-66; device is inserted into uterine cavity);
sealing the cervical canal around a shaft of the medical device (see figures 8A-8D; paragraphs 29-32, 38, 45, and 48-53; balloon (225) is retracted to cervical canal and inflated expanded to seal the cervical canal);
introducing a first fluid into an interior of a fluid-tight chamber of the working end of the medical device (see figures 8A-8D and 11; paragraphs 29-32, 48-53, 58-59; introduction of fluid into the interior chamber (152) of dielectric structure);
introducing a second fluid into the uterine cavity exterior of the fluid-tight chamber (see figures 8A-8D and 11; introduction of CO2 gas into working end from outside fluid source (405)); and
measuring a flow rate/change in pressure/change in volume of the first fluid outward from the fluid-tight chamber in response to the second fluid being introduced into the uterine cavity exterior of the fluid-tight chamber (figures 13 and 14; paragraphs 58-66; note that flow rate has a volume component so that measuring a flow rate would also measure changes in volume).
In regards to claims 2, 14, and 20 Toth discloses the limitations of claims 1, 9 and 15. It can also be seen that the step of sealing the cervical canal includes inflating a sealing balloon against a cervix of the patient (see figures 8A-8D and 11; paragraphs 29-32, 38, 45, and 48-53; balloon (225) is retracted to cervical canal and inflated expanded to seal the cervical canal).
In regards to claims 3-4, 10, and 16, Toth discloses the limitations of claims 1, 9, and 15. In addition, Toth shows in paragraphs 42 and 59 that there are several gas flow passageways/lumens (175, 180, and 120 with the inflow lumen potentially being a plurality of lumens) with the CO2 gas being sent via 120 and the inflation fluid being sent via 175 or 180.
In regards to claims 6-7, 11-12, and 17-18, Toth discloses the limitations of claim 1. In addition, Toth shows the process of expanding the fluid-tight chamber within the uterine cavity into a triangular shape (see figures 8A-8D and 11; paragraphs 29-32, 48-53, and 58-59).
In regards to claims 8, 13, and 19, Toth discloses the limitations of claim 1. In addition, Toth shows the process of ablating tissue in the uterine cavity with the working end of the device (see figures 8A-8D and 11; paragraphs 29-32, 38, 45, 48-53, and 65 describe the ablating of tissue in the uterine cavity).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2011/0112433 (Toth) as applied to claim 1 above, and further in view of US 2010/0114089 (Trukai et al., hereinafter Trukai).
In regards to claim 5, Toth discloses the limitations of claim 1 but does not state that the fluid-tight chamber is made of silicone. In a related area, Trukai discloses endometrial ablation devices and systems (title and abstract; figures 5-10; paragraphs 21-56). Trukai discloses the following steps:
passing a working end (122) of a medical device through a cervical canal and into a patient's uterine cavity (see figures 5, 6, and 8A-8D; paragraphs 29-32 and 48-53; device is inserted into uterine cavity); and
sealing the cervical canal around a shaft of the medical device (see figures 8A-8D; paragraphs 29-32, 38, 45, and 48-53; balloon (225) is retracted to cervical canal and inflated expanded to seal the cervical canal).
Trukai also states that the dielectric wall of the working end is typically made of silicone due to it being a conformable material (paragraphs 9, 14, 25, 45, 49, and 58). Thus, it would have been obvious to one of ordinary skill in the art before the invention was made to modify the method of Toth to use silicone as the material for the fluid-tight chamber as taught by Trukai in due to it being a conformable material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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