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 .
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-11 and 21-28 in the reply filed on July 8, 2026 is acknowledged. The traversal is on the ground(s) that the claims are linked through the same or corresponding technical features. This is not found persuasive because the method requires specific steps that are not required by the product claims. Additionally, the special technical feature(s) do not make a contribution over the art in view of the rejection(s) below.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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 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 1-3, 6-7, 9, 11, 21-22 and 25 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Rome et al. (US 2006/0135949).
With reference to claims 1 and 21, Rome et al. (hereinafter “Rome”) discloses a medical device comprising a tunneler device (abstract) including a shaft including an inner lumen (28) as shown in figure 3E, a proximal portion defining a proximal end (left end of 28, figure 3e), the proximal end being open and providing access to the inner lumen (figure 3E), a distal portion defining a distal end (right end of 28, figure 3E), and an attachment element positioned at the distal end of the shaft (8,44, figure 3E);
wherein the attachment element is configured to capture a distal portion of a medical tube [0072];
wherein the tunneler device is fully capable for insertion within a body of a patient resulting in formation of a tunnel within the body;
wherein insertion of the tunneler device within the body results in concurrent insertion of the medical tube within the body as set forth in [0088].
As to claim 2, Rome discloses a medical device wherein the inner lumen is configured to (fully capable) to receive the medical tube prior to insertion of the tunneler device within the body as set forth in [0088].
Regarding claims 3 and 22, Rome discloses a medical device wherein the attachment element occludes the inner lumen at the distal end of the shaft as shown in figures 3G-3H.
With respect to claim 6, Rome discloses a medical device wherein the attachment element defines a first channel (96) that communicates with a second channel (82), the first channel being in communication with an exterior of the shaft [0074-0075] and the second channel being in coaxial alignment with the inner lumen of the shaft as shown in figure 5B.
As to claims 7 and 25, Rome discloses a medical device of claim 1, wherein the attachment element defines a tapered distal portion as shown in figures 6A-6B.
With reference to claim 9, Rome discloses a medical device wherein the attachment element defines a first cylindrical section (82) configured for insertion within a distal portion of the shaft as shown in figure 5.
Regarding claim 11, Rome discloses a medical device wherein a proximal portion of the first cylindrical section includes a barb as set forth in [0069].
Claims 1-2, 4, 8, 21, 23 and 26-28 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Lun et al. (US 5,342,325).
With reference to claims 1 and 21, Lun et al. (hereinafter “Lun”) discloses a medical device (abstract) comprising a tunneler device including a shaft including an inner lumen (118 with hollow body 122) as discussed in col. 5, lines 63-68 and as shown in figures 7-8 , a proximal portion defining a proximal end (124), the proximal end being open and providing access to the inner lumen (figure 8), a distal portion defining a distal end (right end of 124), and an attachment element (126) positioned at the distal end of the shaft (figures 7-8);
wherein the attachment element is configured to capture a distal portion of a medical tube [0072];
wherein the tunneler device is fully capable for insertion within a body of a patient resulting in formation of a tunnel within the body;
wherein insertion of the tunneler device within the body results in concurrent insertion of the medical tube within the body as set forth in col. 4, lines 55-68 and as shown in figure 5.
As to claim 2, Lun discloses a medical device wherein the inner lumen is configured to (fully capable) to receive the medical tube prior to insertion of the tunneler device within the body as set forth in col. 4, lines 55-68 and as shown in figure 5.
Regarding claims 4 and 23, Lun discloses a medical device wherein the shaft defines a bend angle along the distal portion of the shaft as discussed in col. 2, lines 65-68.
With reference to claim 8, Lun discloses a medical device wherein the attachment element (126) is permanently fixed to the shaft as set forth in figures 7-8.
With respect to claim 26, Lun discloses a system further comprising a handle (19) slidably mounted along an external surface of the shaft as set forth in col. 4, lines 44-52.
Regarding claim 27, Lun discloses a system wherein the handle is removably coupled along the shaft as set forth in col. 4, lines 44-52 where the handle (19) is discloses as selectively mounted.
As to claim 28, Lun discloses a system further comprising a stopper (see generally cylindrical portion of 19 extending towards element 48 in figures 1 and 5) positioned at the proximal end of the shaft and configured to couple with a suction generating device, wherein the stopper includes a stopper aperture (i.e., apertured formed by cylindrical portion that receives element 48) that enables access to the inner lumen at the proximal end of the shaft as set forth in col. 3, lines 35-48.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rome et al. (US 2006/0135949) and further in view of Herweck et al. (US 2001/0032023).
With reference to claim 5, Rome teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Rome and claim 5 is the provision that the attachment element includes at least one receptacle that captures a distal portion of the medical tube in a friction-fit engagement.
Herweck et al. (hereinafter “Herweck”) teaches an analogous tunneling device having an attachment element that includes at least one receptacle that captures a distal portion of the medical tube in a friction-fit engagement as set forth in [0052-0053] and as recited in claims 10-12 and 17-19 of Herweck.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the device of Rome with the attachment element(s) as taught by Herweck in order to provide the device with a convenient method of utilizing suitable elements to perform specific tasks.
As to claim 24, see the rejection of claim 5.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
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