Prosecution Insights
Last updated: April 19, 2026
Application No. 18/498,885

METHODS AND APPARATUS FOR PREVENTING VAGINAL LACERATIONS DURING CHILDBIRTH

Non-Final OA §103§112
Filed
Oct 31, 2023
Examiner
KREMER, MATTHEW
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Materna Medical Inc.
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
4y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allow Rate
196 granted / 448 resolved
-26.2% vs TC avg
Strong +52% interview lift
Without
With
+51.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 5m
Avg Prosecution
58 currently pending
Career history
506
Total Applications
across all art units

Statute-Specific Performance

§101
6.2%
-33.8% vs TC avg
§103
35.5%
-4.5% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
36.2%
-3.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 448 resolved cases

Office Action

§103 §112
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 Applicant should note that the large number of references in the attached information disclosure statements (IDSs) have been considered by the Examiner in the same manner as other documents in Office search files are considered by the Examiner while conducting a search of the prior art in a proper field of search (See MPEP 609.05(b)). The Applicant is requested to point out any particular references in the IDSs which they believe may be of particular relevance to the instant claimed invention in response to this office action (see suggestion 13 of MPEP 2004). One of the IDSs filed on 5/21/2024 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. In particular, on one of the IDSs filed on 5/21/2024, a reference under U.S. Patent Documents (no. 239) was not considered since there is no U.S. Patent Document with the document number 013/0144388. As such, the reference was not properly listed. Claim Objections Claims 22, 36, and 38 are objected to because of the following informalities: in claim 22, line 4: “a vaginal canal” should be “the vaginal canal”; in claim 22, line 4: “the vaginal introitus” should be “a vaginal introitus”; in claim 22, line 5: “the cervix” should be “a cervix”; in claim 22, line 13: “a beginning” should be “a beginning”; in claim 36, line 2: “the urethra and the perineum” should be “an urethra and a perineum”; and in claim 38, line 2: “configuration” should be inserted after “the expanded”. 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 25-26, 28-29, 31-32, 35, and 40-41 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. Claim 25 recites “a series of radial expansions” in line 1, but it is not clear if this recitation is the same as, related to, or different from “a series of radial expansions” of claim 22, line 11. If they are the same, “a series of radial expansions” in claim 25 should be “the series of radial expansions”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the series of radial expansions” (such as, in claim 26) should make it clear which recitation is being referred to. Claim 25 recites “about 3 cm” in line 2 and “about 8 cm” in lines 2-3, which includes the relative term “about” that renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how close one has to be to the target number to be considered “about” the target number. Claim 25 recites “an expanded configuration” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “an expanded configuration” of claim 22, lines 6-7. If they are the same, “an expanded configuration” in claim 25 should be “the expanded configuration”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of “the expanded configuration” (such as, in claim 26) should make it clear which recitation is being referred to. Claim 26 is rejected by virtue of their dependence from claim 25. Claim 26 recites “about 8 cm” in line 2, which includes the relative term “about” that renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how close one has to be to the target number to be considered “about” the target number. Claim 26 recites “the beginning of stage two of labor of the patient” in lines 2-3 in which there is insufficient antecedent basis for this recitation in the claim. Claim 26 recites “wherein the controller sets a period for the series of radial expansions to reach the expanded configuration of about 8 cm prior to the beginning of stage two of labor of the patient” in lines 1-3, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). Claim 28 recites “wherein the controller is configured to apply, during the expansion of the padded exterior, a constant force for expanding the diameter of the padded exterior” in lines 1-2, which appears to contradict the recitation “a controller configured to control the actuation mechanism to expand the padded exterior by a series of radial expansions during which a diameter of the padded exterior is increased by a preselected incremental step and held at the diameter increased by the preselected incremental step until the beginning of a subsequent radial expansion” of claim 22, lines 10-13. The controller cannot apply a constant force and have that force occurring during “a series of radial expansions during which a diameter of the padded exterior is increased by a preselected incremental step and held at the diameter increased by the preselected incremental step until the beginning of a subsequent radial expansion” since the force is fluctuating during and between the series of radial expansions. This contradiction renders claim 28 indefinite. Claim 29 recites “expansion of the diameter of the padded exterior” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a series of radial expansions” in claim 22, line 11. Their relationship should be made clear. Claim 31 recites “the force applied to the padded exterior” in line 2 and “a force” in line 5, but it is not clear if these recitations are the same as, related to, or different from each other or “a force applied for expanding the diameter of the padded exterior” in claim 30, lines 2-3. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Claim 32 is rejected by virtue of its dependence from claim 31. Claim 35 recites “radial expansion” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a series of radial expansions” in claim 22, line 11. Their relationship should be made clear. Claim 40 recites “to remove and reinsert the dilation device” in lines 2-3, but it is not clear what structure is being referred to from which the dilation device is removed and reinserted. Claim 41 is rejected by virtue of its dependence from claim 40. Claim 41 recites “a user” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a user” of claim 40, lines 1-2. If they are the same, “a user” in claim 41 should be “the user”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements. 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. Claims 22-33 and 37-41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2008/0052604 (Sorensen), in view of FR 2460679 (Lavoisier). Citations to Lavoisier will refer to the accompanying English machine translation. With respect to claim 22, Sorensen teaches a device for dilating a vaginal canal of a patient, comprising: a handle (the handle 20 of Sorensen) having a longitudinal axis; a dilation device (the spiral rolled clear tunnel 19 of Sorensen) connected to the handle to extend along the longitudinal axis and being sized to fit in a vaginal canal to traverse the vaginal introitus and extend to a position inferior to the cervix, and having an expandable padded exterior (the plastic exterior of the tunnel of Sorensen and/or the anesthetic coating on the tunnel; paragraphs 0094 and 0096 of Sorensen) configured to expand radially from a contracted configuration having a first diameter to an expanded configuration having a second larger diameter (see FIGS. 5-8 of Sorensen); an actuation mechanism (the electric timer motor 48 of Sorensen; paragraphs 0094 and 0096 of Sorensen) coupled to the dilation device and configured to expand the padded exterior from the contracted configuration to the expanded configuration; and a controller (the timer mechanism of Sorensen; paragraphs 0038 and 0094 and claim 11 of Sorensen) configured to control the actuation mechanism. Lavoisier teaches that the application of increasing diameters can be done gradually or in stages so as to allow a relaxation of the vaginal muscles (page 3 of Lavoisier). It would have been obvious to one of ordinary skill in the art at the time of invention to have the timer mechanism of Sorenson control the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages (i.e., by a series of radial expansions during which a diameter of the padded exterior is increased by a preselected incremental step and held at the diameter increased by the preselected incremental step until the beginning of a subsequent radial expansion) so as to allow a relaxation of the vaginal muscles and provide less trauma to the patient. Also, the combination teaches or suggests that the timer mechanism of Sorenson controls the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages between 3 cm and 11 cm (paragraph 0098-0101 of Sorensen and FIGS. 5-8 of Sorensen) during childbirth. Childbirth may take place in a couple of hours to a couple of days (paragraph 0003 of Sorensen). The stages of opening should take place over a period of time (abstract and paragraphs 0029, 0094, and 0096 of Sorensen). Lavoisier teaches that the application of increasing diameters can be done in stages so as to allow a relaxation of the vaginal muscles (page 3 of Lavoisier). From these teachings, one of ordinary skill in the art would have understood that the number of stages, the size of the device in those stages, and the times of those stages are subject to change. The number of stages, the size of the device in those stages, and the times of those stages would depend upon the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. As such, the number of stages, the size of the device in those stages, and the times of those stages are results-effective variables that would have been optimized through routine experimentation based on the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the number of stages, the size of the device in those stages, and the times of those stages so as to obtain the desired outcome based on the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. With respect to claim 23, the combination teaches or suggests that the controller is configured to control the actuation mechanism to, prior to the series of radial expansions, generate an initial expansion of the padded exterior by having the actuation mechanism expand the padded exterior to a diameter capable of engaging the padded exterior against a tissue wall of the vaginal canal (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages in which the first iterative stage that contacts the tissue is the initial expansion). With respect to claim 24, the combination teaches or suggests that the padded exterior is configured when engaged against the vaginal canal to reduce movement of the dilation device in a direction out of the vaginal canal (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages in which the last iterative stage engages the vaginal canal in such a manner). With respect to claim 25, the combination teaches or suggests that the controller employs a series of radial expansions selected to expand the diameter of the padded exterior from about 3 cm to an expanded configuration of about 8 cm (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages between 3 cm (paragraphs 0051 and 0098 of Sorensen) and 8 cm (paragraph 0053 and 0100 of Sorensen)). With respect to claim 26, the combination teaches or suggests that the controller sets a period for the series of radial expansions to reach the expanded configuration of about 8 cm (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages between 3 cm (paragraphs 0051 and 0098 of Sorensen) and 8 cm (paragraph 0053 and 0100 of Sorensen)) prior to the beginning of stage two of labor of the patient (the state of the patient does not structurally limit the claimed device). With respect to claim 27, the combination teaches or suggests that the combination teaches or suggests that the timer mechanism of Sorenson controls the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages between 3 cm and 11 cm (paragraph 0098-0101 of Sorensen and FIGS. 5-8 of Sorensen) during childbirth. Childbirth may take place in a couple of hours to a couple of days (paragraph 0003 of Sorensen). The stages of opening should take place over a period of time (abstract and paragraphs 0029, 0094, and 0096 of Sorensen). From these teachings, one of ordinary skill in the art would have understood that the number of stages, the size of the device in those stages, and the times of those stages are subject to change. The number of stages, the size of the device in those stages, and the times of those stages would depend upon the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. As such, the number of stages, the size of the device in those stages, and the times of those stages are results-effective variables that would have been optimized through routine experimentation based on the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the number of stages, the size of the device in those stages, and the times of those stages so as to obtain the desired outcome based on the patient’s condition (the comfort and elasticity of the 12 birth canal and 17 dilated cervix; paragraph 0096 of Sorensen) and the practitioner’s judgment. the preselected increment step includes an increment between 0 cm and 4 cm during a predetermined period of time between 0 and 2 hours. With respect to claim 28, the combination teaches or suggests that the controller is configured to apply, during the expansion of the padded exterior, a constant force for expanding the diameter of the padded exterior (the opening speed caused by the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen applies a constant force; paragraph 0094 and 0096 of Sorensen). With respect to claim 29, the combination teaches or suggests a force sensor (the pressure sensor of Sorensen; paragraphs 0094 and 0096 of Sorensen) connected to and arranged on the padded exterior to sense a force applied to the vaginal canal and being coupled to the controller (the pressure sensor is used to determine the optimal progression of opening speed verses comfort and elasticity of the 12 birth canal and 17 dilated cervix such that connection to the timer mechanism is implied, inherent, or understood; paragraphs 0094 and 0096 of Sorensen) and wherein the controller is configured to halt expansion of the diameter of the padded exterior upon sensing the force applied to the vaginal canal reaching a force threshold (the pressure sensor is used to determine the optimal progression of opening speed verses comfort and elasticity of the 12 birth canal and 17 dilated cervix which is based on discomfort or pain threshold, thus, the force must be below this threshold; paragraphs 0094 and 0096 of Sorensen). With respect to claim 30, the combination teaches or suggests that the controller is configured to control the actuation mechanism by adjusting, during the series of radial expansions, a force applied for expanding the diameter of the padded exterior (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages necessarily means an adjusting of the force applied for expanding the diameter of the plastic or anesthetic coated exterior of the tunnel of Sorensen; paragraph 0094 of Sorensen). With respect to claim 31, the combination teaches or suggests a force sensor (the pressure sensor of Sorensen; paragraphs 0094 and 0096 of Sorensen) for measuring the force applied to the padded exterior while holding the diameter at the diameter increased by the preselected incremental step (holding at each stage during tunnel expansion), and wherein the controller is configured to begin the subsequent radial expansion after the force sensor measures a force below a threshold force value (the pressure sensor is used to determine the optimal progression of opening speed verses comfort and elasticity of the 12 birth canal and 17 dilated cervix which is based on discomfort or pain threshold, thus, the force must be below this threshold; paragraphs 0094 and 0096 of Sorensen). With respect to claim 32, the combination teaches or suggests that the controller is further configured to wait a predetermined period of time before beginning the subsequent radial expansion (the timer mechanism of Sorenson controlling the motor so as to expand the spiral rolled clear tunnel 19 of Sorensen in stages and holding in those stages so as to allow a relaxation of the vaginal muscles). With respect to claim 33, the combination teaches or suggests a quick-release mechanism (the button in paragraph 0039 and claim 12 of Sorensen) configured to cause the actuation mechanism to reduce the diameter of the padded exterior to allow for removal of the dilation device from the vaginal canal of the patient. With respect to claim 37, the combination teaches or suggests that the handle (the handle 20 of Sorensen) includes an interior compartment (see FIG. 3 of Sorensen) and the actuation mechanism (the timer motor 48 of Sorensen; paragraph 0094 of Sorensen) is arranged within the interior compartment (see FIG. 3 of Sorensen) and the handle includes a control for operating the actuation mechanism (the finger knob of Sorensen; paragraphs 0094 and 0096 of Sorensen). With respect to claim 38, the combination teaches or suggests that the actuation mechanism includes an electric motor (the electric timer motor 48 of Sorensen; paragraphs 0094 and 0096 of Sorensen) for applying a force to expand and contract the padded exterior between the expanded and the contracted configuration. With respect to claim 39, the combination teaches or suggests a clutch (the limited slip clutch, clutch, and pressure sensing clutch of Sorensen; claims 2, 4, and 6 of Sorensen) for limiting the force applied to expand the diameter of the padded exterior. With respect to claim 40, the combination teaches or suggests that the handle is sized for being gripped by a user for allowing the user to control the actuation mechanism to remove and reinsert the dilation device (the handle 20 of Sorensen is so sized). With respect to claim 41, the combination teaches or suggests that the handle is longitudinally aligned with the dilation device to allow a user to apply to the handle a longitudinally directed force to insert the dilation device into the patient (the handle 20 of Sorensen is so aligned). Claims 22-24 and 34-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7,648,470 (Omata), in view of WO 2005/020814 (Mansour), and further in view of FR 2460679 (Lavoisier). Citations to Lavoisier will refer to the accompanying English machine translation. With respect to claim 22, Omata teaches a device for dilating a vaginal canal of a patient, comprising: a handle (the probe base 5 of Omata) having a longitudinal axis; a dilation device (the balloons 11 of Omata) connected to the handle to extend along the longitudinal axis and being sized to fit in a vaginal canal to traverse the vaginal introitus and extend to a position inferior to the cervix, and having an expandable padded exterior (the balloon surface of Omata) configured to expand radially from a contracted configuration having a first diameter to an expanded configuration having a second larger diameter (col. 5, lines 35-45 of Omata); an actuation mechanism (the pump 13 of Omata) coupled to the dilation device and configured to expand the padded exterior from the contracted configuration to the expanded configuration. Mansour teaches that a processor may activate a pump and reversible activate the pump to deflate a balloon (page 12 of Mansour). It would have been obvious to one of ordinary skill in the art at the time of invention to use a processor to activate and reversible activate the pump of Omata so as to better automate the process. Thus, the combination teaches a controller (the processor suggested by Mansour controlling the pump of Omata ) configured to control the actuation mechanism. Lavoisier teaches that the application of increasing diameters can be done gradually or in stages so as to allow a relaxation of the vaginal muscles (page 3 of Lavoisier). It would have been obvious to one of ordinary skill in the art at the time of invention to have the processor suggested by Mansour control the pump of Omata so as to expand the balloon 11 of Omata in stages (i.e., by a series of radial expansions during which a diameter of the padded exterior is increased by a preselected incremental step and held at the diameter increased by the preselected incremental step until the beginning of a subsequent radial expansion) so as to allow a relaxation of the vaginal muscles and provide less trauma to the patient. Lavoisier teaches that the application of increasing diameters can be done in stages so as to allow a relaxation of the vaginal muscles (page 3 of Lavoisier). From these teachings, one of ordinary skill in the art would have understood that the number of stages, the size of the device in those stages, and the times of those stages are subject to change. The number of stages, the size of the device in those stages, and the times of those stages would depend upon the patient’s condition and the practitioner’s judgment. As such, the number of stages, the size of the device in those stages, and the times of those stages are results-effective variables that would have been optimized through routine experimentation based on the patient’s condition and the practitioner’s judgment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the number of stages, the size of the device in those stages, and the times of those stages so as to obtain the desired outcome based on the patient’s condition and the practitioner’s judgment. With respect to claim 23, the combination teaches or suggests that the controller is configured to control the actuation mechanism to, prior to the series of radial expansions, generate an initial expansion of the padded exterior by having the actuation mechanism expand the padded exterior to a diameter capable of engaging the padded exterior against a tissue wall of the vaginal canal (the processor suggested by Mansour control the pump of Omata so as to expand the balloon 11 of Omata in stages in which the first iterative stage that contacts the tissue is the initial expansion). With respect to claim 24, the combination teaches or suggests that the padded exterior is configured when engaged against the vaginal canal to reduce movement of the dilation device in a direction out of the vaginal canal (the processor suggested by Mansour control the pump of Omata so as to expand the balloon 11 of Omata in stages in which the last iterative stage engages the vaginal canal in such a manner). With respect to claim 34, the combination teaches or suggests that the padded exterior includes a plurality of radially movable arms (the balloons 11 of Omata) configured to expand radially outwardly from the longitudinal axis. With respect to claim 35, the combination teaches or suggests that the plurality of radially movable arms are arranged to be disposed to engage tissue proximate a pubic bone of the patient and apply force against the tissue proximate the pubic bone during radial expansion (the balloons 11 of Omata are so capable; col. 5, lines 35-45 of Omata). With respect to claim 36, the combination teaches or suggests that the radially movable arms are arranged to engage tissue proximate a pubic bone of the patient and to be spaced away from the urethra and the perineum of the patient (the balloons 11 of Omata are so capable; col. 5, lines 35-45 of Omata). Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7,648,470 (Omata), in view of WO 2005/020814 (Mansour), and further in view of FR 2460679 (Lavoisier), and further in view of GB 2444034 (Matchilskaiai). Citations to Lavoisier will refer to the accompanying English machine translation. Matchilskaiai discloses a button valve 25 of an inflatable vaginal device that can rapidly deflate balloons after use and before extraction (pages 7 and 9 of Matchilskaiai). It would have been obvious to one of ordinary skill in the art at the time of invention to include a button valve external to the patient as disclosed by Matchilskaiai in the apparatus of Omata since it would permit rapid deflation of the balloons of Omata before extraction. With respect to claim 33, the combination teaches or suggests a quick-release mechanism (the button valve of Matchilskaiai) configured to cause the actuation mechanism to reduce the diameter of the padded exterior to allow for removal of the dilation device from the vaginal canal of the patient. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off. 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, JACQUELINE CHENG can be reached at (571) 272-5596. 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. /MATTHEW KREMER/Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Oct 31, 2023
Application Filed
May 03, 2024
Response after Non-Final Action
Feb 03, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
44%
Grant Probability
96%
With Interview (+51.9%)
4y 5m
Median Time to Grant
Low
PTA Risk
Based on 448 resolved cases by this examiner. Grant probability derived from career allow rate.

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