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 .
Response to Amendment
The amendments filed on 03/05/2026 have been entered. Claims 1-4, 6, and 8 remain pending in the application. The amendment overcome the claim objections and rejection under 35 USC 112(b) set forth in the previous office action dated 12/31/2025.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. Applicant argues on page 7 that the cylindrical propelling body 324 of Dejima is housed within tubular body 322 and therefore does not provide an outwardly protruded surface which would be configured to contact tissue within the uterine cavity. It is the examiners position that the device is at least capable of being used in a manner in which the surface can contact tissue of a uterine cavity because member 324 is separable form tubular body 322, see FIGs 3A-3B and 8A-8C, and can hold instruments within the grooves via treatment tool fixture 450 and endoscope fixture 430. Therefore, the device is at least capable of being sued in a manner in which the outwardly protruded surface can separate tissue within a uterine cavity from the guiding groove.
Applicant further argues on pages 7-8 that it would not have been obvious to modify the front end of the cylindrical propelling body to be arc-shaped as required by the claim. However, it is the examiners position that the device of Dejima meets the limitation of the front end being arc shaped without the need for modification. For example, FIG 5 shows various arc shaped portions of a front end of the body. The claim as written does not specify the direction of curvature.
Lastly, applicant argues on page 8 that the handle 340 of Dejima is attached to tubular body 322 and therefore is not “arranged on a rear end of the cylindrical propelling body”. However, examiner notes that 340 is still “arranged on the rear end” as required by the claim, as shown in FIG 3A-3B. at least some portion of 324 is connected to proximal end cap 340 as demonstrated by the fact that 324 does not slide proximally out of the cap. Therefore, as shown in the cross sections of FIG 11A-11B, at least some piece of 340 is “arranged on” the rear end of 324. For at least these reasons, applicants’ arguments are not found to be persuasive.
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.
Claim(s) 1, 2, 4-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima et al. (US 2018/0296073) in view of Tal (US 2017/0056237).
Regarding claim 1, Dejima et al. discloses a single-piece hysteroscopic instrument operation propeller (324, FIG 4, [0077-0080]), configured for being slidably connected with a hysteroscope body ([0078] discloses the guide system facilitates slidable introduction of endoscope 100, FIG 1 and 11A-11B, therefore the device is at least configured for being connected with a hysteroscope body, which is a type of endoscope. Examiner notes that a hysteroscope is not a positively recited element of the claim) comprising: a cylindrical propelling body (324, see generally cylindrical shape in FIG 4 and 8A-8C), having one side outer surface (Right side as viewed in FIG 4 which forms groove 326) being provided with an engagement groove (326, [0078]) configured for fitting with the hysteroscope body (Since 324 is disclosed as receiving an endoscope, it is also configured to receive a hysteroscope), and an other side outer surface (Left side as viewed in FIG 4 which forms 328) being provided with a guiding groove (328) extending along a longitudinal direction of the hysteroscope body (If a hysteroscope were inserted within groove 326, similar to 100 as shown in FIG 1 and 11B, the guide grieve 328 extends in a longitudinal direction thereof, see FIG 11B) and recessed towards the one side surface of the cylindrical propelling body (FIG 4 shows the curvature of the groove 328 extends towards the direction of groove 326), wherein the cylindrical propelling body is configured to be slidable along a length of the hysteroscope body during treatment ([0111] discloses the endoscope is slidable within the cylindrical propelling body. Although disclosed as occurring before insertion into the patient, there are no locks or features which would prevent further slidable adjustment after insertion into the patient. Therefore, the cylindrical propelling body is configured to be slidable along a length of the hysteroscope body during treatment), and a transverse section of the guiding groove is arc shaped (See arc shape in FIG 4 and 7-8C), wherein a surface portion of the cylindrical propelling body located between an opening of the engagement groove and an opening of the guiding groove (See annotated FIG 4 below) is protruded outwardly (The surface portions protrude radially outward relative to the openings of the grooves), and the protrudes surface portion is divided into two sections (Top and bottom as shown in the annotated FIG 4 below) symmetrically distributed along a longitudinal section of the cylindrical propelling body (See symmetry in FIG 4 and FIG 7 for example), and a transverse section, perpendicular to the longitudinal direction of the hysteroscope body (FIG 7 best shows a perfectly perpendicular cross section), of an outwardly protruded surface of each section is arc-shaped (See arc space protruding outwardly and connecting from the opening of the guiding groove to the opening of the engagement groove); the outwardly protruded surface is configured to separate tissue within a uterine cavity from the guiding groove (because the outwardly protruded section forms a structural separation between the guiding groove and at least some tissue if the device were inserted within a uterine cavity); wherein a front end of the cylindrical propelling body is arc shaped (FIG 5 shows various arc shaped portions of a front end of the body), a push-pull handle (340, FIG 3A-3B) is arranged on a rear end of the cylindrical propelling body (as shown in FIG 3A-3B and 11A-11B, wherein 324 is attached to an constrained to 340by being received within 322) and is configured for sliding the hysteroscope body relative to the engagement groove (340 is positioned at the proximal end of 324 can could be held by a used while the hysteroscope body is translated relative to the cylindrical propelling body).
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Dejima et al. is silent regarding the cylindrical propelling body being made of stainless steel.
However, Tal teaches a cylindrical propelling body (14, FIG 2A-2C) for use in a uterine procedure (FIG 1, abstract, [0026]) wherein the body is made of stainless steel ([0027]. Tal also discloses the body is flexible and alternatively could be made of a polymer ([0027]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the polymer material of Stefanchik to be stainless steel, as taught by Tal, for the purpose of substituting a commonly known biocompatible material while maintaining the desired flexibility properties.
Further, Dejima discloses a radian of the guiding groove is equal to π (See FIG 7 wherein the groove forms a semicircle) but not wherein the radian is less than π.
However, it would have been an obvious matter of design choice to modify the radian to be slightly less than π, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). The modification would also be obvious since applicant has not disclosed that having the radian be less than π provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Paragraph [0008] of the specification of the present invention discloses the benefit of having a groove radian be greater than π, but does not provide criticality of a groove arc being less than π.
Regarding claim 2, Dejima/Tal disclose the invention substantially as claimed, as set forth above for claim 1. Dejima further discloses a transverse section of the engagement groove is arc-shaped (See arc shape of 326 in FIGs 4, and 7-8C).
Regarding claim 4, Dejima/Tal disclose the invention substantially as claimed, as set forth above for claim 1. Dejima further discloses a length of the cylindrical propelling body is configured to be less than a length of the hysteroscope body (FIG 11B shows a length of the cylindrical propelling body being less than the length of endoscope 100, and therefore it is capable of being less than the length of a hysteroscope used in the same manner).
Regarding claim 6, Dejima/Tal disclose the invention substantially as claimed, as set forth above for claim 1, Dejima further discloses a surface of the front end of the cylindrical propelling body is configured to be adjacent to a front end of the hysteroscope body (FIG 11B shows the distal end or the front end is adjacent to a front end of endoscope 100. Therefore it is at least configured to achieve the claimed arrangement if 100 were a hysteroscope).
Claim 3 and 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dejima et al. (US 2018/0296073) in view of Tal (US 2017/0056237), in view of Germain et al. (US 2017/0055811),
Regarding claim 3, Dejima/Tal disclose the invention substantially as claimed, as set forth above for claim 1. Dejima et al. discloses a radian of the engagement groove is equal to π (See FIG 7 wherein the groove forms a semicircle) but not wherein the radian is greater than π.
However, Germain et al. discloses a hysteroscopic instrument operation propeller (200, FIGs 3A-6C; [0069] discloses 200 is configured to connect to a hysteroscope represented by shaft 250. Therefore, the adapter 200 is interpreted as a “hysteroscopic instrument operation propeller” because it attaches to and aids in the insertion of a hysteroscope 500), comprising: a cylindrical propelling body (202), one side surface of the cylindrical propelling body being provided with an engagement groove (Channel 205, FIG 3B, 4) configured fitting with a hysteroscope body (250, FIGs 6A-6C, [(0062, 0065, 0069-0071]. Further, FIG 9 discloses hysteroscope 500 and [0084] discloses connecting 200 to the hysteroscope), wherein a transverse section of the engagement groove is arc-shaped (See transverse view in FIG 4 wherein 205 is arc shaped), and wherein a radian of the engagement groove is greater than π (A radian of the groove being greater than π means greater than 180 degrees. FIGs 6A-6C show the engagement groove extends radially along more than 180 degrees).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify guiding groove of Dejima to have a radian at least slightly greater than π, as taught by Germain, for the purpose of increasing the securement of the hysterscope within the groove such that accidental translation of the hysteroscope relative to the groove is restricted and only sliding/translating movement is permitted (Germain [0062]).
Regarding claim 8, Dejima/Tal disclose the invention substantially as claimed, as set forth above for claim 1. Dejima further discloses a surgical instrument (200, [0063] such as forceps) which enters along the guiding groove ([0078-0080]), and that the present invention is applicable for use in surgical settings of inserting an endoscope into a body cavity of the patient ([0058-0063]).
Dejima fails to disclose the body cavity being a uterus and therefore further fails to provide specific step including combining the cylindrical propelling body with a hysteroscope body through the engagement groove; sending the hysteroscope body into a uterine cavity; and adjusting a position of the cylindrical propelling body along the hysteroscope body under a hysteroscope view, such that a surgical instrument is able enter the uterine cavity along the guiding groove.
However, Germain et al. discloses a method for operating the single-piece hysteroscopic instrument operation propeller comprising following steps: combining a cylindrical propelling body (200) with the hysteroscope body (250) through an engagement groove (205, FIGs 6A-6C, wherein [0069] discloses that shaft 250 can be a hysteroscope. Further, FIG 9 discloses hysteroscope 500 and [0084] discloses connecting 200 to the hysteroscope); adjusting a position of the cylindrical propelling body along the hysteroscope body ([0065] disclose the body being slidable along the hysteroscope), such that a surgical instrument is able to enter the uterine cavity along the guiding groove ([0064-0065] discloses use of a surgical instrument of some kind within the guiding groove. Insertion of the body and the hysteroscopy into the uterine cavity would therefore enable a surgical instrument to be inserted as well).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771