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 1-17 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.
The claims are replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The non-standard structure of the claims appears to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. The Examiner will try to address all of the issues below, but asks Applicant to review the claims as well.
Claim 1 includes “one end of an actuation cable” in lines 1-2 and then refers to “one end of an actuation cable” in line 6 and “the end of an actuation cable” in lines 9 and 12-13. This is improper as the claim is not clear as to whether or not these are the same ends. One way to correct the issue is to state “A method for fixing an end of an actuation cable” and then refer to “the end of the actuation cable”. Other solutions are possible. The Examiner assumes that these are the same ends. Appropriate correction is required.
Claim 1 also refers to “an actuation cable” throughout without ever switching to “the actuation cable”. Again, this is unclear as the language creates ambiguity as to how many cables are being claimed. The Examiner assumes only one such that each subsequent recitation of actuation cable should be preceded by “the”. Appropriate correction is required.
Claim 1 in line 4 refers to “this part” instead of “the part”. The use of “this” renders the claim indefinite because “this” implies there is a “that” or some other part, but as currently drafted there is only a single part. Using “the” clarifies that the claim is referring to the previously referenced “part”. Appropriate correction is required.
Claim 1 includes the use of the word “region” in lines 5, 9, 11, and 14. In the first instance, the part is provided with “at least one region” and not simply “a region”. The second usage is to “the region” and is unclear as to whether or not this is intended to be the same region as the first recitation. Maybe not as “a” is used instead of “the”, but the second usage seems to be the same region in that it also refers to a “region made of thermoplastic material”. Applicant should use the same convention to help clarify. If these are the same region, then the second reference should be to “the at least one region”. The third and fourth use of the term present the same problem as the second. Are these all the same region or different regions. The Examiner assumes they are the same. Appropriate correction is required.
Claim 2 refers to “the end” and not necessarily “one end”. The Examiner prefers “the” over “one”, but the claims should be consistent with their terminology. Here, the Examiner assumes this is the same end as that in claim 1. Appropriate correction is required.
Claims 3-6 refer to “a serrated welding head” where claim 1 already introduces a serrated welding head. Is this the same head or a different head? The claim is not clear. The Examiner assumes they are the same such that the second recitation should be to “the serrated welding head”. Appropriate correction is required.
Claims 3-6 refer to either a number or series of hollows or teeth where claim 1 already refers to “teeth alternately separated by hollows”. The Examiner treats that as meaning there are at least three teeth and two hollows because “hollows” is plural and two teeth would only require a single hollow to separate them. The dependent claims reference to additional hollows and teeth is indefinite because it is unclear if these are the same or different from the hollows and teeth in claim 1. The Examiner assumes they are the same. Appropriate correction is required.
Claim 3 also provides a range within a range using the term “preferably”. The Examiner assumes the larger range sets forth the scope of the claim, but the use of “preferably” renders the claim indefinite. The Specification is the proper place for discussing preferences, not the claims. Appropriate correction is required.
Claim 5 also refers to “either side of the actuation cable” where no sides have previously been claimed. This creates confusion as to which “sides” these are or what they may be within the claimed configuration. Furthermore, because cables are circular or round, the use of the word “side” is not clear in that the cross-section of a circle does not have sides. What does Applicant mean by sides in this context? The Examiner does not know. Appropriate correction is required.
Claim 7 refers to “the region” and suffers from the same problems addressed above for claim 1. Appropriate correction is required.
Claim 8 uses the term “ensures” without explicitly claiming the step of ultrasonic welding. The Examiner assumes the actuation cable is fixed to the part using ultrasonic welding or the method further includes ultrasonically welding the actuation cable to the part. Claim 9 is similarly worded and presents the same problem. Appropriate correction is required.
Claim 10 uses the term “it” without clarifying what “it” is. The Examiner assumes the pivoting part is configured to orient a distal head of a medical device. Claim 10 then refers to “a part” when “a part” has already been claimed. Again, the use of “this pivoting part” is unclear (see discussion of claim 1 above). Finally, the use of “the fixing of a proximal end of an actuation cable” is indefinite because “the fixing” implies an already claimed fixing step, which is not the case and a new actuation cable, hence “an” instead of “the”. The Examiner assumes that this is the same actuation cable and this is a new fixing step. Appropriate correction is required.
Claim 11 lacks a transitional phrase (comprising, consisting, or consisting essentially of). Claim 1 also lacked such a phrase, but “including” is considered to be the same as comprising. Here, “provided with” is not clear. This claim may be either open or closed. The Examiner assumes the claim is open where “provided with” is equivalent to “comprising” as the context provided by the disclosure as a whole suggests this. The claim also appears to require the actuation cable because the bead is trapping an anchoring portion of an actuation cable embedded into the part. The claim then refers to “the portions” without providing proper antecedent basis. Finally, “either side” is used again without setting forth any sides to begin with. The Examiner is treating the claim as requiring a fixing region made of a thermoplastic material having at least one bead made of the thermoplastic material and an actuation cable having an anchoring portion, a first portion, and a second portion, wherein the at least one bead is configured to trap the anchoring portion of the actuation cable such that the anchoring portion is embedded into the fixing region by being recessed between the first portion and the second portion of the actuation cable. Appropriate correction is required.
Claim 12 uses the term “it” where this is improper. The Examiner assumes this is “the part”, but the reference could be to any of the nouns in claim 11. Appropriate correction is required. Claim 12 also suffers from some of the same issues as claim 11 with respect to “either side” and the overall structure of the claim language (see discussion of claim 11 above). Appropriate correction is required.
Claim 13 uses the term “it” (see discussion of claim 12 above), mentions “beads”, and “in the vicinity of the inlet”. Claim 11 already refers to “at least one bead”, so this claim is unclear as to whether or not these beads are the same as the at least one bead in claim 11 or if they are different beads altogether. “[I]n the vicinity” does not provide a reasonable means of determining what is or is not within the scope of the claim and is a relative term of degree. The disclosure fails to provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. Furthermore, “the inlet” is without proper antecedent basis. The Examiner assumes the part further comprises wherein the at least one bead is located adjacent an inlet of a guide groove of the actuation cable. Appropriate correction is required.
Claim 14 refers to “the bead” without providing proper antecedent basis. The claim is not clear as to whether these are the same beads as the “at least one bead” in claim 11. Appropriate correction is required.
Claim 15 is similar to claim 10 and has the same problems (see discussion of claim 10 above). Appropriate correction is required.
Claim 16 uses the term “it”. As discussed above, this is improper (See discussion of claim 12 above). Appropriate correction is required.
Claim 17 is similar to claim 10 (see discussion of claim 10 above) and is rejected based on the problems with claim 11, from which the claim depends. The Examiner is interpreting the claim as being directed to a control handle for a medical device comprising (“including” being construed to be an open term equivalent to “comprising”) a control mechanism configured to orient a distal head of the medical device, wherein the control mechanism includes a part in accordance with claim 11. The Examiner’s discussion of claim 11 applies here as well. 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 11 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (US 2019/0231179) in view of Barfoot et al. (US 2020/0165055).
Regarding Claim 11¸Hansen discloses:
A part of a control mechanism provided with at least one fixing region (see Fig. 6b showing region 94c) having at least one bead (see Fig. 6b showing the head of pin engaging the wire 5; see marked up drawing below) trapping an anchoring portion (52) of an actuation cable embedded into the part by being located recessed from the portions of the actuation cable located on either side of the anchoring portion (see Fig. 6b showing the left and right portions of 52; see marked up drawing below).
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Hansen does not explicitly disclose wherein the fixing region an at least one bead is made of a thermoplastic material. Hansen does disclose that the pin is resilient and designed to snap into place (see Paragraph 0090). Barfoot is analogous art in that it too is providing a snap fit for pins (see Paragraph 0099), and Barfoot’s pins are made from a thermoplastic, resilient material. The selection of a resilient material is the problem, and Barfoot is reasonably pertinent to that problem. 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 Hansen’s pin to be made from Barfoot’s thermoplastic. Such a modification incorporates a well-known material that has the desired property of resiliency so that a pin can be snapped into place.
Regarding Claim 15, Hansen as modified further discloses wherein the part is a pivoting part (42) being a part of a control mechanism making it possible to orient the distal head of a medical device (see Fig. 4 showing the pin 9 as part of the lever system 42 for articulating the distal tip 33).
Regarding Claim 16, Hansen as modified further discloses wherein it is in the form of a disk or of an annular ring (see Fig. 4 showing the control mechanism and pivoting part in the form of a disk or annular ring) to form an actuation pulley (42 is a ring with the control wires attached thereto such that the ring acts as a pulley to control the wires 5 and 5’ and articulate the distal tip 33).
Regarding Claim 17¸ Hansen as modified further discloses:
A control handle for a medical device (see Fig. 1 showing the handle 2) including a control mechanism (42) making it possible to orient the distal head of a medical device (see Fig. 4 showing how 42 is used to articulate the distal tip 33), the control mechanism including a part in accordance with claim 11 (see rejection of claim 11 above).
Allowable Subject Matter
Claims 1-10 and 12-14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Given the significant number of 112b issues, the Examiner is hesitant to indicate that anything would necessarily be allowable without seeing how Applicant addresses those issues. However, from an art standpoint, the Examiner did not find anything that reads on a part of a control mechanism made of a thermoplastic material that connects to an actuation cable by having a bead trap an anchoring portion of the cable so that the anchoring portion becomes embedded in the part by being recessed relative to adjacent portions of the cable. The method, which sets forth how this is accomplished, was similarly not found or rendered obvious by the prior art.
Claims 12-14 require more than one bead. Hansen fails to include multiple bead that could be considered to read on the claim. One region is provided with one “bead”, but to include more would be superfluous. Without some teaching in the prior art, the Examiner considers such a modification to be impermissible hindsight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hijihara (US 2017/0238787) showing different means for attaching a cable to a pulley.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795