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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024, 05/15/2025, and 03/31/2026 was filed after the mailing date of the application on 06/28/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The Examiner notes that claims filed 06/28/2024 are under examination herein, despite the more recent filing of claims 11/27/2024.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Regarding claims 1-9, the claims recite a “medical-device hook”, but does not describe a hook in the claimed features, nor is the purpose of the hook defined. The intended limitation of the pre-amble is not clear for this claim. The Examiner is interpreting the medical-device hook to be encompassed by any art that teaches the components of the medical-device hook as recited in claim 1 even though no hook structure is explicitly described.
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.
Claims 1, 3, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Niwa (EP 1 634 529 A1), herein after “Niwa”.
Regarding claim 1, Niwa teaches
“A medical-device hook (Fig. 10) to be attached to a medical device including a tubular portion (1 in Fig. 8) to be inserted into a body lumen (Fig. 1), the medical-device hook comprising an inset opening (22) allowing the tubular portion (1) to be inset into the inset opening (Fig. 8) and a surrounding portion around the inset opening (22a; Examiner interprets the element being able to accept the portion but does not interpret surround to mean enclose), the surrounding portion being configured to deform elastically to come in close contact with the tubular portion inset (1b) in the inset opening such that the tubular portion is held due to frictional resistance on a closely contacted portion between the surrounding portion around the inset opening and the tubular portion (p.[0023] in combination with Fig. 3, see also Fig. 8 and p.[0044])”.
Regarding claim 3, the limitations of claim 1 are taught as described above. Niwa teaches that the surrounding portion 22a is elastic (see p.[0044])) and elastically deforms when the tubular portion 1 is inset into the inset opening 22 in order to hold the tubular portion in p.[0022-0024] and therefore teaches the claimed limitation as described.
Regarding claim 7, the limitations of claim 1 are taught as described above. Niwa teaches that the device is formed of an elastomer resin in p.[0044] which states that “The holding device… is formed of an elastic material” therefore teaching the claimed invention.
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.
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 2, 4-6, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Niwa.
Regarding claim 2, the limitations of claim 1 are taught as described above. Niwa shows the medical-device hook (20) on a hanger (30) in Figure 8, with the surrounding portion 22a configured to deform elastically as described in p.[0022-0023], and that the entire structure 20 can be made of an elastic material (and is capable of creating friction as elastic material can deform when placed under load, see p.[0044]). It is the Examiner's position that the system of Niwa would accomplish the claimed limitation of deforming the inset opening elastically in the presence of a weight (such as from a medical device in the same inset opening as the tubular portion) as Niwa describes an inset opening that can accomplish elastic deformation when an object (such as a medical device) is acted upon it. It would have been obvious to one of ordinary skill in the art to place and hold a medical device in the inset opening of Niwa via elastic deformation of the surrounding portion of the inset opening. Niwa contemplates that the inset opening is originally intended for the holding of a probe/tubing, but could be modified to hold a therapeutic device such as grasping forceps (p.[0044]) and such a modification would produce predictable results of a similar medical device via elastic deformation of the surrounding portion of the inset opening.
Regarding claim 4 and 10, the limitations of claim 2 are taught as described above. Niwa shows that the inset opening includes a hole and a slit in Figures 2 and 3 and therefore teaches the claimed limitation as described.
Regarding claim 5 and 11, the limitations of claim 2 are taught as described above. Niwa shows that the inset opening includes a hole having a diameter larger than the outer diameter of the tubular portion in Figure 2, 3, and 10 and therefore teaches the claimed limitation as described.
Regarding claim 6 and 12, the limitations of claim 2 are taught as described above. Niwa shows that the inset opening includes a slit having a width narrower than the outer diameter of the tubular portion in Figure 2, 3, and 10 and therefore teaches the claimed limitation as described.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Niwa in view of Sigmon (WO 2014/151780).
Regarding claim 8, the limitations of claim 1 are taught as described above. Niwa does not teach a medical device comprising a tubular portion to be inserted into a body lumen or a grip portion connected to the base end of the tubular portion, but Sigmon does in an analogous medical device system. Sigmon shows in Figure 1 a medical device (100) with a tubular portion to be inserted into a body lumen (catheter 150) and grip portion connected to the base of the tubular portion (handle body 180). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Sigmon in Niwa to arrive at the claimed invention. As stated in Sigmon (p.[0008]) the use of this device allows for easy management of looped catheters or similar tubular structures and produces predictable results of maintaining catheter/tubular integrity during use.
Regarding claim 9, the limitations of claim 8 are taught as described above. Niwa does not teach that the medical device hook is attached to the grip portion so as to pose a slant with respect to a direction of gravity when the medical-device hook is hung on a hanger, but the system of Niwa/Sigmon does. If the medical device hook of Niwa were to be combined with the base end of the grip portion of Sigmon, the medical device hook would hang with a slant with respect to the direction of gravity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Sigmon in Niwa to arrive at the claimed invention. Both the inventions of Sigmon and Niwa attempt to solve the same problem of holding tubular structures during medical procedures and produce predictable results of maintaining the position of said tubular structures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 5712724764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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