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 .
Election/Restrictions
Applicant’s election without traverse of Species C, Species 9, and Method Z in the reply filed on May 4, 2026, is acknowledged.
Claims 24 and 29 are withdrawn as being directed to a non-elected species. Claim 24 refers to a heat sink shown in Fig. 19C (Species D), and Claim 29 refers to a strain relief shown in Fig. 20A, which is part of unelected Species E.
Claims 21-23, 25-28, and 30-31 are addressed on the merits below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sleeve” must be shown or the feature(s) canceled from the claim(s). The Examiner notes that the term “sleeve” appears in the Specification, but at no point is the term identified with the Drawings. If the “sleeve” is in the Drawings, then the Specification should reference the sleeve with a corresponding number from the Drawings. The Examiner assumes that sheath 1720 is the sleeve. The “guide” of claim 23 should also be shown. The inner body of cannula 1910 is said to function as a guide tube, but this is not a separate guide as claimed. The subject matter of claim 31 is not clearly shown. Nothing shows the first and second optical pathways.
No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “1727”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 requires a guide not clearly shown in the drawings or described in the Specification as originally filed. Therefore, the limitation is considered new matter. The same can be said of the first and second optical pathways of claim 31. If anything, the LEDs are disclosed as illuminating the area for the photodetector chip such that they would seemingly be directed along the same optical pathway. Because these claims are not part of the original disclosure and are not clearly shown nor described in the Specification, a person having ordinary skill in the art would reasonably conclude that Applicant was not in possession of the claimed invention at the time of filing.
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.
Claim 31 is 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 31 refers to both the “light source” (claim 21) and the “plurality of micro-LED elements” (claim 30). First, the claim does not depend from claim 30 creating a lack of antecedent basis problem. Second, the claim includes both the light source and plurality of LEDs such that it is unclear whether or not these are the same thing. The Examiner assumes that they are. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 21-23, 25, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 4,254,762) in view of Shibata et al. (US 2008/0243162).
Regarding Claim 21, Yoon discloses:
A surgical instrument, comprising:
a distal outer assembly including a distal housing (40), wherein the distal outer assembly forms a passageway to pass at least one of fluid and instruments therethrough (see Fig. 7 showing 40 as hollow);
a visualization stylet assembly (10 and 26) configured to be at least partially disposed within the passageway of the distal outer assembly (see Fig. 7 showing 10 within 40), the visualization stylet assembly being removably coupled to the distal outer assembly (10 can be removed from 40 by means of 30, see Fig. 1a showing the disassembled device), the visualization stylet assembly including:
an elongate body (14) having a proximal end and a distal end (14 has proximal and distal ends as shown in Fig. 7); and
a proximal housing (26) to receive a proximal region of the elongate body (26 is at the proximal end of the elongate body 14);
a sleeve (54) slidably disposed about at least a distal tip region of the removable visualization stylet assembly (54 extends distally to 50 and the two tubular elements can slide relative to one another in that one can be removed from the other), the sleeve including a window (56 or 60 act as a window) disposed at a distal end thereof to direct light through the window toward the imaging means, wherein at least a portion of the sleeve is configured to extend through the passageway of the distal housing (see Fig. 7 showing 54 extending through 14), and
further wherein:
the distal outer assembly and the elongate body of the visualization stylet assembly can be decoupled from each other (the components are removably attached; see Fig. 1a for example);
the sleeve is configured to be disengaged from the elongate body of the visualization stylet assembly (the device is designed to be disassembled; see Col 7 Lines 6-7).
Yoon does not explicitly disclose an electronic photodetector chip mounted proximate the distal end of the elongate body, the electronic photodetector chip having a distally facing surface to detect incoming light traveling along a proximal direction; and a light source configured to project light beyond the electronic photodetector chip in a distal direction to provide direct forward illumination. The Examiner notes that such features are common in the art for acquiring images within the patient. Shibata is one example of a similar device with an image sensor (38) and a light source (39) at the distal end of an endoscopic device to supply light and acquire images from within the patient. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon’s device to have Shibata’s sensor and light. Such a modification replaces the old eyepiece technology with modern chips as is known in the art. Modern sensors allow for images to be acquired, processed, displayed on a screen, and have all the features that well-known digital imaging provides.
Regarding Claim 22, Yoon as modified further discloses wherein the visualization stylet assembly further includes a distally facing connector (27) to removably couple to the sleeve.
Regarding Claim 23, Yoon as modified further discloses wherein the distal outer assembly further includes a guide (proximal shoulder of 44 and/or cap 46 help with guiding the stylet into the passageway) to guide the visualization stylet assembly into the passageway.
Regarding Claim 25, Yoon as modified further discloses wherein the proximal housing defines a proximal cavity in which a proximal end of the elongate body of the visualization stylet assembly is received (26 includes an open portion as seen in Figs. 1 and 7 that receives the proximal end of 14).
Regarding Claim 28, Yoon as modified further discloses:
A method comprising providing a device according to claim 21 (see rejection of claim 21 above), introducing the device into an anatomical region of a patient (Col 7 Lines 47-55), and inspecting at least one anatomical feature inside the patient using the visualization stylet (Col 7 Lines 47-55; the device punctures the wall of a body cavity and provides a means for assessing the situation within the cavity).
Regarding Claim 30, Yoon as modified further discloses wherein the light source includes a plurality of micro-LED elements disposed radially outwardly with respect to the electronic photodetector chip (Shibata – see Fig. 6 and Paragraph 0112).
Regarding Claim 31, Yoon as modified further discloses wherein the light source, wherein the plurality of micro-LED elements are configured to direct light along a distal direction along a first optical pathway that is spatially distinct from and radially outwardly displaced from a second optical pathway associated with the electronic photodetector chip(Shibata – see Fig. 6 and Paragraph 0112; the LEDs are space apart radially from the image sensor) .
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 4,254,762) and Shibata et al. (US 2008/0243162), as applied to claim 21 above, and further in view of Adams (US 2006/0020165).
Yoon and Shibata disclose the invention substantially as claimed as stated above.
Regarding Claim 26, they do not explicitly disclose wherein the distal housing includes a flush port operably coupled thereto, the flush port being configured to direct a liquid from a source of liquid through the flush port, into the distal housing and through the passageway. Yoon does disclose a flush port (49) operably coupled to the distal housing, the flush port being configured to direct a liquid from a source of liquid through the flush port, into the distal housing and through the passageway. The Examiner notes that Yoon does not have much to say about 49, and in Fig. 7 the port is in a different location. However, Adams teaches a similar port (50) for supplying a liquid to a site (Paragraph 0041), and the Examiner notes that supplying liquid to surgical sites is well-known in the art. For example, during joint surgery, fluid is often used to flush the joint free of any debris. Fluid is also commonly used to clear and clean the distal end of inserted devices (see Paragraph 0042). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon’s distal housing to include Adams’ flush port. Such a modification incorporates a well-known feature (irrigation port) into the embodiment of Fig. 7 to provide a means for supplying liquid to the target site as is known in the art.
Regarding Claim 27, Yoon as modified further discloses:
A method comprising providing a device according to claim 26 (see rejection of claim 26 above), operably coupling the flush port to the source of liquid, and directing liquid from the liquid source through the passageway of the distal housing into an anatomical region of a patient (see Adams Paragraph 0041).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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