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 .
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 5 and 12 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.
Regarding claim 5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The examiner requests amendment of claim 5 in order to distinctly claim the subject matter of the disclosure.
Regarding claim 12, the limitation “an intermediate portion proximal with respect to the gripping portion” renders the claim indefinite as it is unclear based upon the specification and drawings what the term “intermediate portion” refers to. The gripping portion as interpreted by the examiner is element 61 of figure 5 of the applicant’s disclosure, and it can be seen that there is no portion of introducer body 60 proximal to the gripping element 61 that could be labeled an “intermediate portion”. The examiner requests amendment of claim 12 in order to distinctly claim the subject matter of the disclosure and suggests replacing “proximal” with “distal” in the highlighted limitation of this rejection.
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.
Claims 1, 2, 4, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gallego et al (European Patent Application EP3449805A1, hereinafter “Gallego”) in view of Abbate et al (U.S. Patent Application Publication 2010/0211093, hereinafter “Abbate”). Regarding claim 1, Gallego teaches a rectoscope for inspecting a cavity of an individual, comprising:
a dilator body (figure 1 element 1), extending prevalently along a longitudinal axis, between a proximal end and a distal end, wherein the proximal end and the distal end are connected by a side wall and define, together with said side wall, an inner volume (figure 1 see space inside cylinder 1 spanning between the distal (3) and proximal (2) ends)
wherein the proximal end identifies a proximal opening (figure 1 opening 6) coaxial with said longitudinal axis and is connected to a gripping element (figure 1 element 4), which is accessible or graspable by an operator
wherein the distal end identifies a distal opening (figure 1 element 2), for access to the tissues delimiting said cavity from the inner volume
said dilator body comprising in said proximal end a cover movable between a first position (figure 2 element 7), in which said cover defines a closing of said proximal opening (PO), and a second position in which said cover is moved away from the proximal opening so as to make said inner volume of the dilator body accessible (figure 1 element 7 see that figure 1 depicts the cover lifted while figure 2 depicts the cover in a closed configuration)
However, Gallego fails to teach a rectoscope wherein said cover comprises at least one window made of a frangible material and breakable in use, when said cover is in said first position, to allow a controlled access to the inner volume of the dilator body.
Abbate teaches a rectoscope wherein said cover (figure 16a element 1604) comprises at least one window made of a frangible material and breakable in use (par 119 details how apertures 1608 of figure 16a are covered by a breakable membrane or film), when said cover is in said first position, to allow a controlled access to the inner volume of the dilator body (par 119 pressure breaking the film over the apertures allows access to the inner volume). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the rectoscope of Gallego with the frangible cover material of Abbate in order to allow for a controlled release of pressure as required by an operation, as a smaller breakable film on the cover creates a smaller change in pressure when broken as opposed to the change accompanying opening the cover fully. This lesser, controlled pressure release ensures that sudden large changes in pressure that could damage the target region inside a patient are avoided during an operation.
Regarding claim 2, Gallego further teaches a rectoscope wherein said dilator body also comprises, in said proximal end, a cannula adapted to favor (figure 1 nozzle 8 described in paragraph 20), when said cover is in said first position, a communication of air from the outside of the dilator body to the inner volume, said cover, or said at least one window preventing, when said cover is in said first position, an exit of air from the inner volume towards the outside of the dilator body through said proximal opening (in the first position the cover is closed (figure 2 element 7), so air cannot exit the dilator body through the proximal opening).
Regarding claim 4, Gallego and Abbate combined teach the limitations of claims 1, and Abbate further teaches a rectoscope wherein said at least one window is made in the form of a hole made on said cover, said hole being occluded by a film (paragraph 119 details how apertures 1608 of figure 16a are covered by a breakable membrane or film). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the rectoscope of Gallego with the window occluded by a film of Abbate in order to allow for a controlled release of pressure as required by an operation, as a smaller breakable film on the cover creates a smaller change in pressure when broken as opposed to the change accompanying opening the cover fully. This lesser, controlled pressure release ensures that sudden large changes in pressure that could damage the target region inside a patient are avoided during an operation.
Regarding claim 8, Gallego further teaches a rectoscope wherein said cover comprises a base coupled or defined at the proximal end and an overturning portion movable between the first and the second position with respect to the base by means of a hinge coupling (figures 1 and 2 see element 7 in both the first and second position as the cover is moved about its hinge connection).
Regarding claim 9, Gallego further teaches a rectoscope comprising lighting means to generate a direct light beam from the proximal end towards the distal end and wherein said dilator body has a cavity obtained inside it, at the proximal end, said lighting means being contained inside said cavity to generate said light beam directly inside the dilator body or the inner volume (paragraph 22 details a light source 12 within the dilator body positioned to send light distally from the proximal end of the cavity).
Regarding claim 10, Gallego further teaches a rectoscope wherein said gripping element comprises a first element (figure 3 handle 4), solidly constrained to the dilator body, and a second element couplable to the first element (figure 3 element 20 (lid couplable to the handle by a hinge)).
Claims 3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gallego and Abbate in view of Norton et al (U.S. Patent 11,571,118, hereinafter “Norton”). Regarding claim 3, while Gallego and Abbate combined teach the limitations of claim 1 and teach a rectoscope comprising a cover, they fail to teach a cover comprising at least one pair of windows opposite with respect to a central portion of the cover itself. Norton teaches a cover (figure 2 element 101) comprising at least one pair of windows (figure 2 elements 11) opposite with respect to a central portion of the cover itself. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cover of Gallego and Abate with the cover comprising a pair of windows of Norton in order to increase the clarity of the view of the target region within the patient’s body by providing two light source outputs. The addition of an extra light source better illuminates the target region, and adds lighting redundancy should one window become covered by debris or tissue during an operation. This improved clarity and redundancy allows for an operator to more safely operate a device within the patient, as well as improve diagnosis ability with a more defined image.
Regarding claim 6, while Gallego and Abbate combined teach the limitations of claim 1, they fail to teach a rectoscope comprising an acquisition device configured to acquire images in a portion external to said distal opening and wherein said cover further comprises at least one connection seat for said acquisition device, defined in a central portion of the cover itself, and provided with a transparent window or a lens defining an acquisition axis passing through the distal opening. Norton teaches an acquisition device (figure 3 element 119) configured to acquire images in a portion external to said distal opening and wherein said cover further comprises at least one connection seat (figure 3 element 107) for said acquisition device, defined in a central portion of the cover itself (connection seat is located within a central portion of cover 101), and provided with a transparent window or a lens (figure 3 cover 133) defining an acquisition axis passing through the distal opening (distal opening being the distal lens of the acquisition device through which an image is captured). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the rectosope of Gallego and Abbate with the acquisition device and connection seat of Norton in order to capture images or video of the target region within the patient for use during an operation or during diagnosis/treatment planning after an operation.
Regarding claim 7, while Gallego and Abbate combined teach the limitations of claim 1, they fail to teach a rectoscope comprising a lighting device configured to generate a light beam passing through the proximal opening and the distal opening and wherein said at least one connection seat is also configured, in use, to allow the connection or the maintaining of said lighting device in said central portion of the cover. Norton teaches a lighting device (as detailed in the paragraph spanning from column 4 line 64 to column 5 line 10) configured to generate a light beam passing through the proximal opening and the distal opening (light passes through proximal and distal sides of the connection seats 111 in figure 2) and wherein said at least one connection seat is also configured, in use, to allow the connection or the maintaining of said lighting device in said central portion of the cover (connection seats 111 in figure 2 can hold lighting means (optical fibers or mediums) as detailed in the paragraph spanning from column 4 line 64 to column 5 line 10). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the rectoscopes of Gallego and Abbate with the lighting devices of Norton to increase the clarity of the view of the target region within the patient’s body by providing two light source outputs. The addition of an extra light source better illuminates the target region, and adds lighting redundancy should one window become covered by debris or tissue during an operation. This improved clarity and redundancy allows for an operator to more safely operate a device within the patient, as well as improve diagnosis ability with a more defined image.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gallego and Abbate in view of Smith et al (U.S. Patent Application Publication 2021/0361147, hereinafter “Smith”). While Gallego and Abbate combined teach the limitations of claim 1, they fail to teach a rectoscope wherein said at least one window is made or delimited by weakening lines, said weakening lines preferably defining a cross delimiting the window itself. Smith teaches a rectoscope wherein said at least one window (figure 4a element 166’) is made or delimited by weakening lines (paragraph 55 details that the perforations 166’ that make up the window are structured to break/open upon application of a pressure or force), said weakening lines preferably defining a cross delimiting the window itself. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the window of Abbate with the weaking lines of Smith in order to create an automated (precipitated by a certain pressure level reached within the cap) pressure release function that protects the patient from a potentially harmful pressure buildup within the device during a surgical operation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gallego and Abbate in view of Oddenino (European Patent Application EP 0771545A1). While Gallego and Abbate combined teach the limitations of claims 1 and 9, they fail to teach a rectoscope wherein said second element has a termination adapted to accommodate and to retain said lighting means. Oddenino teaches a rectoscope wherein said second element (figure 1 handle 3) has a termination (paragraph 18 “seat 22” in figure 1) adapted to accommodate and to retain said lighting means (paragraph 18 “ light guide insert 23” in figure 1 and paragraph 19 “optical fibre 27”)). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the rectoscopes of Gallego and Abbate with the second element and termination of Oddenino in order to provide for a modular lighting system for the rectoscope. The termination of Oddenino allows for the attachment of an optical fiber to the rectoscope system, giving the operator choice of a certain intensity of light to be supplied as needed by the operation, by connecting a different light and optical fiber configuration to the termination of the second element. This variety of light source choice allows for the correct level of lighting to be supplied to the target region of the patient as required by a specific operation.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gallego and Abbate in view of Brefka et al (U.S. Patent 5,249,568, hereinafter “Brefka”). While Gallego and Abbate teach the limitations of claim 1, and teach a rectoscope comprising a cover movable between a first and second position, they fail to teach a rectoscope further comprising an introducer body, having a gripping portion, accessible or graspable by the operator, connected to an insertion portion having an elongated extension along the longitudinal axis between an insertion end, of substantially ogival shape, distal with respect to the gripping portion, and an intermediate portion proximal with respect to the gripping portion, said insertion portion being slidably insertable within, and disengageable from, the inner volume through the proximal opening when said cover is in the second position. Brefka teaches a rectoscope further comprising an introducer body (figure 1 element 14), having a gripping portion (figure 1 element 36), accessible or graspable by the operator, connected to an insertion portion (figure 1 element 34) having an elongated extension along the longitudinal axis between an insertion end, of substantially ogival shape (figure 1 see oglival shape of element 34), distal with respect to the gripping portion, and an intermediate portion proximal with respect to the gripping portion, said insertion portion being slidably insertable within (figure 1 see slidable insertion configuration of element 14 within the cavity of element 10), and disengageable from, the inner volume through the proximal opening. It would have been obvious before the effective filing date of the claimed invention to modify the rectoscopes of Gallego and Abbate with the introducer body of Brefka in order to facilitate an easier entry of the dilator into the patient’s tissue. The oglival shape of the distal tip of the introducer allows for a more comfortable entry process for the rectoscope, minimizing pain and potential injury to the patient during a procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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