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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/4/2025 has been entered.
Election/Restrictions
Newly submitted claim 30 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Invention of claim 30 is a mutually exclusive species to the invention as originally presented. The method of claim 3 presented 6/11/2021 requires directing liquid through a visualization scope. Further, this feature is incorporated into the independent claim 1 of 2/10/2025. The method of claim 30 of 9/4/2025 requires a visualization scope incapable of directing liquid and a catheter capable of directing liquid but incapable of imaging. Otherwise, it would be unintuitive and wasteful to remove an irrigation catheter to introduce a visualization scope and vice versa as claimed in the method of claim 30 of 9/4/2025. Hence, new method claim 30 of 9/4/2025 is drawn to a materially different process than what was originally claimed due to requiring a materially different apparatus for performing said process.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 30 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
Amendment to claims 1, 2, 6, 8, 10-15, 21, 22 of 9/4/2025 acknowledged and entered.
New claims 25-30 of 9/4/2025 acknowledged and entered.
Cancellation of claims 3-5, 7, 23, 24 of 9/4/2025 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 9/4/2025 have been fully considered but they are not persuasive. Regarding p. 8, para. 2, amendment to abstract does not address the recitation of legal phraseology. The term “said fallopian tube” remains in the 5th line of the amended abstract.
Applicant’s arguments, see p. 8, para. 4, filed 9/4/2025, with respect to the rejection(s) of claim(s) 1 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nikolchev.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. (Emphasis added)
Claim Objections
Claim10 objected to because of the following informalities: claim indicates a change to "wherein the includes digital camera includes", which is improper grammar. 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.
Claim(s) 1, 2, 6, 8-10, 12-14, 21, 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolchev (WO 9524149 A1) in view of Skieller (US 20170258392 A1) and Barton (US 20210244346 A1).
Regarding claim 1, Nikolchev teaches A diagnostic method for evaluating an intrapelvic condition, comprising:
introducing a hysteroscope (fig. 7, element 10, p. 6, para. 5, hysteroscope 10) through a cervix of a patient, the hysteroscope defining a first passageway (fig. 7, element 12, p. 6, para. 5, working shaft 12) therethrough;
advancing the hysteroscope until a distal end of the hysteroscope is disposed within a uterus of the patient (fig. 10, element 12, p. 6, para. 5, hysteroscope introduced to uterus);
while the distal end of the hysteroscope is disposed within the uterus of the patient, introducing a catheter (fig. 7, element 40, p. 6, para. 5, access catheter 40 introduced over a guidewire) through the passageway of the hysteroscope, the catheter defining a second passageway therethrough (p. 6, para. 5, catheter has a hole for accommodating guidewire and imaging probe);
advancing the catheter into the uterus beyond the distal end of the hysteroscope (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
directing the catheter into a Fallopian tube of the patient (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
advancing the catheter along the Fallopian tube of the patient such that a distal end of the catheter is disposed in the Fallopian tube of the patient (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
while the distal end of the catheter is disposed in the Fallopian tube of the patient, advancing a scope through the second passageway (p. 6, para. 5, guide wire is replaced by a fiber optic imaging element 60 inserted through the catheter 40)
Nikolchev does not explicitly teach the method wherein the imager extends out of a distal end of the catheter, the scope having a digital camera disposed at a distal end thereof;
advancing a distal end of the scope along the Fallopian tube:
visually inspecting the Fallopian tube using the digital camera while advancing the distal end of the scope along the Fallopian tube:
advancing the distal end of the scope out of the Fallopian tube proximate an ovary of the patient;
visually inspecting the ovary using the digital camera;
advancing the scope into the pelvic cavity of the patient; and
visually inspecting an outer surface of the uterus of the patient
However, Skieller teaches the method wherein the imager extends out of a distal end of the catheter (fig. 11d, element 1112, [0154], distal end of visualization instrument 1112 is advanced distally to perform visualization), the scope having a digital camera disposed at a distal end thereof ([0090], CCD as an imager);
advancing a distal end of the scope along the Fallopian tube ([0154], advancement of the visualization instrument through the fallopian tube):
visually inspecting the Fallopian tube using the digital camera while advancing the distal end of the scope along the Fallopian tube ([0154], advancement of the visualization instrument through the fallopian tube:
However, Barton teaches advancing the distal end of the scope (fig. 10, element 202, [0041] falloposcope 202) out of the Fallopian tube proximate an ovary of the patient ([0068], distal end of falloposcope threaded through fallopian tube and positioned in proximity to a first ovary);
visually inspecting the ovary using the digital camera ([0068], distal end of falloposcope threaded through fallopian tube and positioned in proximity to a first ovary;
advancing the scope into the pelvic cavity of the patient; and
visually inspecting an outer surface of the uterus of the patient (fig. 10, falloposcope distal tip is positioned in the pelvic cavity, which enables viewing of at least a portion of the outer surface of the uterus within the field of view of the falloposcope).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include extending an imaging probe past the distal tip of the catheter as taught in Skieller in order to flexibly follow the contours of the fallopian tube (Skieller [0153]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include extending the imager to the ovaries and beyond as taught in Barton in order to screen for ovarian cancer (Barton [0003]).
Regarding Claim 2, Nikolchev in view of Skieller and Barton teaches The method of Claim 1, wherein
Barton further teaches the scope is directed from outside the patient through the vagina, uterus, and Fallopian tube into the pelvic cavity without puncturing a tissue structure (fig. 10, falloposcope passes through the body lumen out of the fallopian tubes and is positioned proximate the ovaries in the pelvic cavity).
Regarding Claim 6, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Skieller further teaches the method further comprising detecting at least one abnormality associated with endometriosis using the scope ([0007] Endometriosis is among the diseases of the fallopian tubes examined for).
Regarding Claim 8, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Barton teaches further comprising:
aspirating a fluid sample from said abdominal cavity ([0086], fluid introduction and aspiration is used to collect cell samples) through the channel of the scope, wherein the scope includes at least one radial stiffening element configured to prevent the channel of the scope from collapsing radially inwardly when under negative fluid pressure (fig. 3, element 312, [0059], stainless steel tubular portion 312 would have rigidity); and
performing at least one testing procedure on the fluid sample in order to detect at least one abnormality ([0008], diagnosis of abnormalities is applied to cell samples).
Regarding Claim 9, Nikolchev in view of Skieller and Barton teaches The method of Claim 8,
Barton further teaches the method wherein the at least one testing procedure is configured to detect at least one of
cancerous tissue ([0008], cancer is one of the screened abnormalities), and
endometriosis.
Regarding Claim 10, Nikolchev in view of Skieller and Barton teaches The method of Claim 1, Further, Skieller teaches the method wherein
the includes digital camera includes an electronic photodetector chip ([0090], image sensor includes a CCD) disposed proximate to the distal end of the scope for receiving incoming light and
a light emitting device proximate to the distal end of the scope ([0090], LED light source or fiber optics), and
the method further comprises directing light onto a tissue structure and observing the tissue structure using the electronic photodetector chip ([0090]).
Regarding Claim 12, Nikolchev in view of Skieller and Barton teaches The method of Claim 1
Barton teaches the method further comprising
directing liquid into the pelvic cavity by way of the visualization scope ([0086], cell collection via fluid introduction and aspiration, fig. 10 shows the scope disposed in the pelvic cavity).
Regarding Claim 13, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Nikolchev teaches the method further comprising conducting a diagnostic or treatment regimen using the scope (p. 2, para. 6, diagnostic testing and treatment),
Skieller teaches repeating the method a plurality times over a plurality of examinations in order to track progress of a treatment regimen of the patient ([0012] patient may return for repeat procedures).
Regarding Claim 14, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Barton teaches the method further comprising
directing a therapeutic agent through the scope to treat tissue inside of the patient (therapy agents may be delivered rather than cell collection fluid).
Regarding claim 21, Nikolchev in view of Skieller and Barton teaches The method of Claim 6,
Barton further teaches the device further comprising discharging a laser pulse to the abnormality from the visualization scope ([0043], laser-based illumination, hence any applied illumination is a laser pulse).
Regarding claim 25, Nikolchev in view of Skieller and Barton teaches The diagnostic method of Claim 1,
Further, Nikolchev teaches the device wherein the catheter has a diameter of 5 French (p. 4, para. 9, diameter of lumen 20, which the catheter passes through, measure 1-2mm, of 3-6 French).
Regarding claim 26, Nikolchev teaches A diagnostic method for evaluating an intrapelvic condition, comprising:
introducing a hysteroscope (fig. 7, element 10, p. 6, para. 5, hysteroscope 10) through a cervix of a patient, the hysteroscope defining a first passageway therethrough (fig. 7, element 12, p. 6, para. 5, working shaft 12);
advancing the hysteroscope until a distal end of the hysteroscope is disposed within a uterus of the patient (fig. 10, element 12, p. 6, para. 5, hysteroscope introduced to uterus);
while the distal end of the hysteroscope is disposed within the uterus of the patient, introducing a catheter (fig. 7, element 40, p. 6, para. 5, access catheter 40 introduced over a guidewire) through the passageway of the hysteroscope, the catheter defining a second passageway therethrough;
advancing the catheter into the uterus beyond the distal end of the hysteroscope (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
directing the catheter into a Fallopian tube of the patient (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
advancing the catheter along the Fallopian tube of the patient such that a distal end of the catheter is disposed in the Fallopian tube of the patient (p. 6, para. 5, catheter will be introduced until distal end approaches fimbria);
while the distal end of the catheter is disposed in the Fallopian tube of the patient, advancing an elongate medical device through the second passageway (p. 6, para. 5, guide wire is replaced by a fiber optic imaging element 60 inserted through the catheter 40)
Nikolchev does not explicitly teach the method wherein the imager extends out of a distal end of the catheter, the elongate medical device defining a lumen therethrough and defining a fluid port proximate a distal end of the elongate medical device;
advancing the distal end of the elongate medical device along the Fallopian tube, out of the Fallopian tube and into the pelvic cavity of the patient;
collecting a sample from the pelvic cavity of the patient; and
testing the sample for at least one abnormality.
However, Skieller teaches the method wherein the imager extends out of a distal end of the catheter, the elongate medical device defining a lumen therethrough and defining a fluid port proximate a distal end of the elongate medical device (fig. 11d, element 1112, [0154], distal end of visualization instrument 1112 is advanced distally to perform visualization);
advancing the distal end of the elongate medical device along the Fallopian tube([0154], advancement of the visualization instrument through the fallopian tube),
However, Barton teaches advancing the device (fig. 10, element 202, [0041] falloposcope 202) out of the Fallopian tube and into the pelvic cavity of the patient ([0068], distal end of falloposcope threaded through fallopian tube and positioned in proximity to a first ovary);
collecting a sample from the pelvic cavity of the patient ([0086], fluid introduction and aspiration is used to collect cell samples); and
testing the sample for at least one abnormality ([0008], diagnosis of abnormalities is applied to cell samples).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include extending an imaging probe past the distal tip of the catheter as taught in Skieller in order to flexibly follow the contours of the fallopian tube (Skieller [0153]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include extending the imager to the ovaries and beyond as taught in Barton in order to screen for ovarian cancer (Barton [0003]).
Regarding claim 27, Nikolchev in view of Skieller and Barton teach The method of Claim 26,
Further, Barton teaches the method wherein the abnormality includes cancer ([0007], method for screening a patient for ovarian cancer).
Regarding claim 28, Nikolchev in view of Skieller and Barton teach The method of Claim 26,
Further, Barton teaches the method wherein the abnormality includes ovarian cancer ([0007], method for screening a patient for ovarian cancer).
Regarding claim 29, Nikolchev in view of Skieller and Barton teach The method of Claim 26,
Further, Skieller teaches the method wherein the abnormality includes endometriosis ([0007], Endometriosis would be detected by the evaluation as described in Skieller).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolchev in view of Skieller and Barton as applied to claim 1 in further view of Pravong (US 20120082970 A1).
Regarding Claim 11, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Nikolchev in view of Skieller and Barton does not explicitly teach the method further comprising tilting the pelvis of the patient in order to move the bowels out of the way of the scope.
However, Pravong teaches the method further comprising tilting the pelvis of the patient in order to move the bowels out of the way of the scope ([0063] Trendelenburg position allows for gravity to pull intestines away from pelvis, which is where the scope is located).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include placing the patient in the Trendelenburg position in order to prevent encroachment of the intestines upon the operating field and provide more working space in the abdominal cavity (Pravong [0063]).
Claim(s) 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolchev in view of Skieller and Barton as applied to claim 1 in further view of de Koning (US 20170303903 A1).
Regarding Claim 15, Nikolchev in view of Skieller and Barton teaches The method of Claim 1,
Nikolchev in view of Skieller and Barton does not explicitly teach a method wherein the visualization scope includes an uneven outer surface configured to collect a tissue sample from a patient as the visualization scope passes over tissue of a patient.
However, de Koning teaches a method wherein the visualization scope includes an uneven outer surface (fig. 15, 16, element 360) configured to collect a tissue sample from a patient as the visualization scope passes over tissue of a patient ([0080-81] sample collecting device 360 composed of a series of bristles 376).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include a device with bristles as taught in de Koning in order to sample the vaginal space (de Koning [0003])
Regarding Claim 16, Nikolchev in view of Skieller, Barton and de Koning teaches The scope of Claim 15,
Further, de Koning teaches the device wherein the uneven outer surface includes a plurality of hair-like elements (fig. 15, 16, element 376, [0080-81] sample collecting device 360 composed of a series of bristles 376).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolchev in view of Skieller and Barton in view of Adams (US 20080097468 A1).
Regarding claim 22, Nikolchev in view of Skieller and Barton teaches The method of Claim 6,
Nikolchev in view of Skieller and Barton do not explicitly teach the device further comprising delivering electrical energy to the abnormality from the scope.
However, Adams teaches the device further comprising delivering electrical energy to the abnormality from the scope ([0152], electrocautery probe).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nikolchev to include an electrocautery device as taught in Adams in order to treat a gynecological disorder (Adams [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795