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 Objections
Claims 1-20 are objected to because of the following informalities: Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). 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 1-20 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 1 fails to include a transitional phrase (comprising, consisting of, or consisting essentially of) rendering the open or closed nature of the claim indeterminate. The claim could be either. Furthermore, the claim does not clearly set forth the structural limitations of the targeting device. Without a transitional phrase and without clearly setting forth the structural features of the targeting device, the Examiner asserts that a person having ordinary skill in the art would not be able to determine the metes and bounds of the claim. The targeting device is being treated as comprising a plurality of needle guides with the claimed features. Appropriate correction is required.
Claim 14 states “wherein the targeting device is azimuthally broken through between the hollow needle guides.” The Examiner does not know what this means, and this format places a method step (is azimuthally broken through”) in an apparatus claim. The Specification fails to provide any details related to this feature such that a person having ordinary skill in the art would not be able to determine the metes and bounds of the claim. The Examiner assumes that the device is capable of being broken through. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, 7-14, and 18-20 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Bunch et al. (US 2014/0358087).
Regarding Claim 1, Bunch discloses:
A targeting device for a targeted guidance of a hollow needle with an endoscopic-surgical operation, wherein the targeting device is fastened or can be fastened to an endoscopy unit which extends essentially in an endoscopy longitudinal axis and defines a viewing region (functional language, Bunch’s device and attach to an endoscopy unit at 540),
wherein the targeting device defines a plurality of hollow needle guides (538a-e),
wherein each of the hollow needle guides each extends towards the viewing region along a different polar angle with respect to the endoscopy longitudinal axis (see Fig. 10C showing the guide directing the needle to the end of 510; each guide is at a different location and has a different polar angle),
wherein each of the hollow needle guides is open towards one of its two azimuthal sides over its entire length (see Figs. 9-14C showing the opening of the guides for receiving the needle).
Regarding Claim 2, Bunch further discloses wherein each hollow needle guide comprises a proximal guide end and a distal guide end, wherein the proximal guide end of each of the hollow needle guides essentially have the same distance to the viewing region (see Figs. 9-10C, for example, showing the curved nature of the proximal end such that the distance to the viewing region is essentially the same).
Regarding Claim 5, Bunch further discloses wherein adjacent hollow needle guides are connected to one another each at the proximal guide end and at the distal guide end (see Fig. 9, for example, showing the adjacent guides connected to one another).
Regarding Claim 7, Bunch further discloses a fastening element (540) for a tool-free releasable fastening to the endoscopy unit.
Regarding Claim 8, Bunch further discloses wherein the fastening element is configured to at least partly embrace an access tube of the endoscopy unit in a designated manner and to be clamped onto the access tube (see Fig. 10B, for example, showing the tube 510 clamped to 540).
Regarding Claim 9, Bunch further discloses wherein the fastening element is arranged at a distal end region of the targeting device (see Fig. 9 showing the location at the distal end).
Regarding Claim 10, Bunch further discloses wherein the fastening element comprises a quick release lever or clamping lever (592).
Regarding Claim 11, Bunch further discloses wherein the fastening element comprises a positive-fit element configured to form a positive fit with a corresponding positive-fit element provided on the endoscopy unit at a defined position along the endoscopy longitudinal axis (see Fig. 10A, for example, showing the positive fit elements that correspond to one another, see Paragraph 0064 (the Examiner notes that the endoscopy unit is only functionally recited and is not part of the targeting device)).
Regarding Claim 12, Bunch further discloses wherein the hollow needle guides are formed by a single-piece guide element (see Fig. 9, for example, showing the guides as a single piece).
Regarding Claim 13, Bunch further discloses wherein the hollow needle guides are additively manufactured as a single-piece unit (product-by-process limitation that does not produce a structure different from the reference; Bunch’s guides are a single-piece unit as seen in Fig. 9).
Regarding Claim 14, Bunch further discloses wherein the targeting device is azimuthally broken through between the hollow needle guides (Bunch’s targeting device can be broken as desired).
Regarding Claim 18, Bunch further discloses wherein each of the hollow needle guides has an inner diameter for axially receiving the hollow needle and at its open azimuthal side comprise an opening slot with a clear slot width, wherein the clear slot width is smaller than the inner diameter (see Figs. 11A-11C showing the slot width in 11B being smaller than the inner diameter).
Regarding Claim 19, Bunch further discloses wherein apart from the hollow needle guides, the targeting device comprises open and/or closed hollow chambers (see Figs. 11A-11C showing the hollow chambers allowing for 571 to extend therein).
Regarding Claim 20, Bunch further discloses wherein the hollow needle guides are arranged in a meridionally rowed manner (see Figs. 9-14C showing the guides extending along the meridionally along the arc).
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 3, 15-17, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bunch et al. (US 2014/0358087) in view of Torrie (US 2010/0241106).
Bunch discloses the invention substantially as claimed as stated above.
Regarding Claim 3, Bunch does not explicitly disclose wherein for every pair which is selected from the hollow needle guides, the distal guide end of a first hollow needle guide of a pair extends along a first polar angle and has a first distance to the viewing region and the distal guide end of a second hollow needle guide of the pair extends along a second polar angle and has a second distance to the viewing region, wherein the first polar angle is smaller than the second polar angle and the first distance is smaller than the second distance.
Torrie discloses a configuration where the relative distances of the distal end of the guide decreases as the angle relative to the endoscopy unit decreases (see Fig. 7 showing guide 80). This configuration provides a larger attachment area for attachment to the endoscopy unit while maintaining a smaller profile for the needle guides to reduce weight, bulk, and unnecessary material. 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 Bunch’s device to include Torrie’s profile. Such a modification provides a large attachment area for securing the guide to the endoscopy unit while reducing the size of the guide without changing the function of the device.
Regarding Claim 15, Bunch does not explicitly disclose wherein at least one of the hollow needle guides comprises a distal guide section and a proximal guide section, wherein the targeting device between the distal guide section and the proximal guide section comprises at least one free section, in which the hollow needle is not guided.
Torrie teaches placing openings (67) in a needle guide to make the guide lightweight. Therefore, it would have been obvious to modify Bunch’s guide to include Torrie’s openings. Such a modification reduces the weight of the guide making it easier to handle and helping it cool after autoclaving.
Regarding Claim 16, Bunch does not explicitly disclose wherein for each pair selected from the hollow needle guides, a first hollow needle guide of a pair extends along a first polar angle and a second hollow needle guide of the pair extends along a second polar angle, wherein the at least one free section of the first hollow needle guide is longer than the at least one free section of the second hollow needle guide and the first polar angle is smaller than the second polar angle.
Torrie discloses a configuration where the relative distances of the distal end of the guide decreases as the angle relative to the endoscopy unit decreases (see Fig. 7 showing guide 80). This configuration provides a larger attachment area for attachment to the endoscopy unit while maintaining a smaller profile for the needle guides to reduce weight, bulk, and unnecessary material. When combined with the embodiment in Fig. 5, these free spaces would conform to the shape of the guide. A person having ordinary skill in the art would understand from Torrie’s teaching that reducing weight is beneficial, and that elongating the free spaces 67 of Torrie would further achieve that goal. 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 Bunch’s device to include Torrie’s profile. Such a modification provides a large attachment area for securing the guide to the endoscopy unit while reducing the size of the guide without changing the function of the device.
Regarding Claim 17, Bunch does not explicitly disclose wherein for each pair selected from the hollow needle guides, a first hollow needle guide of a pair extends along a first polar angle and a second hollow needle guide of the pair extends along a second polar angle, wherein a length of the first hollow needle guide is larger than a length of the second hollow needle guide and the first polar angle is smaller than the second polar angle.
Torrie discloses a configuration where the relative distances of the distal end of the guide decreases as the angle relative to the endoscopy unit decreases (see Fig. 7 showing guide 80). This configuration provides a larger attachment area for attachment to the endoscopy unit while maintaining a smaller profile for the needle guides to reduce weight, bulk, and unnecessary material. 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 Bunch’s device to include Torrie’s profile. Such a modification provides a large attachment area for securing the guide to the endoscopy unit while reducing the size of the guide without changing the function of the device.
Regarding Claim 21, Bunch discloses:
An endoscopy system for an endoscopic-surgical operation, the endoscopy system comprising:
at least one hollow needle (561); and
a targeting device (500) for a targeted guidance of the at least one hollow needle towards the viewing region along a selectable polar angle with respect to the endoscopy longitudinal axis, wherein the targeting device is fastened or can be fastened to the unit (using 540), wherein the targeting device defines a plurality of hollow needle guides (538a-e), wherein each of the hollow needle guides extends towards the viewing region along a different polar angle with respect to the endoscopy longitudinal axis (see Fig. 10C showing the guide directing the needle to the end of 510; each guide is at a different location and has a different polar angle), wherein each of the hollow needle guides is open towards one of its two azimuthal sides over its entire length (see Figs. 9-14C showing the opening of the guides for receiving the needle).
Bunch does not explicitly disclose an endoscopy unit extending essentially in an endoscopy longitudinal axis and defines defining a viewing region. Torrie teaches using an endoscopy unit (20) to visualize insertion of the needle. 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 Bunch’s device to include Torrie’s endoscopy unit. Such a modification provides a means to visualize the needle as it is being introduced to the target.
Regarding Claim 22, Bunch as modified further discloses wherein the endoscopy unit comprises an access tube extending essentially in the endoscopy longitudinal axis and an endoscope which can be inserted into the access tube from a proximal side (see Torrie – cannula 40 with endoscope 20 inserted therein in Fig. 2).
Regarding Claim 23, Bunch as modified further discloses wherein the targeting device is releasably fastened to a proximal end section of the access tube in a tool-free manner (see Bunch element 540 includes 592 to releasably fasten the tube to the targeting device without a tool).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bunch et al. (US 2014/0358087) in view of Henalla (US 6,071,230).
Bunch discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the proximal guide end of each of the hollow needle guides widen proximally in a funnel-like manner and each forms a defined stop for the hollow needle. Funnels are well-known structure for facilitating entry into the guide, and a stop prevents over insertion into the patient. Henalla teaches a funnel-shaped opening for 28 and a stop 32 to facilitate insertion into the guide. 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 Bunch’s guides to include Henalla’s funnel and stop. Such a modification facilitates insertion into the guide and prevents the needle from being over inserted.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bunch et al. (US 2014/0358087) in view of Kamler (US 2019/0328210).
Bunch discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the hollow needle guides are open towards different ones of their two azimuthal sides in an alternating manner. Kamler teaches a holding device with alternating open and closed sides (see Figs. 5A-5D). The Examiner also notes that the difference between the prior art and the claim is nothing more than a minor rearrangement of parts that would not change the operation of the device. 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 Bunch to include Kamler’s alternating open guides. Such a modification allows for tools to be inserted and attached to the guide from either side and does not change the function of the device.
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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