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 without traverse of group I in the reply filed on 3/9/2026 is acknowledged.
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 1-9, 11, 15 and 16 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.
In claim 1, Applicant amended “distal end” to “a distal end” (on what is now line 6) in order to address the examiner’s objection. However, the examiner suggested “the” not “a”. It is now unclear how “a distal end” on line 6 is related to that on line 4. They are treated as being the same and the second instance is “the”
In claim 1, it is unclear to what “a respective number of wire extending inside the tubular member from the proximal end” is respective. It is treated as if “each of the at least two sections has a respective number of wires...”. Further, it does not seem feasible that “each wire affixed to the distal end of each section” as it would require every wire to affixed to the distal end of every section. The examiner suggests “each wire affixed to the distal end of its respective section”.
Claim 15 is a single claim which claims both an apparatus and a method step. Such is indefinite because it is not directed to the system, but the actions of a user, which creates confusion as to when direct infringement occurs. See MPEP 2173.05(p). The claim details the use of the steerable arm with a transmission tube.
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.
Claim(s) 1, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovac et al (US 6,171,316) in view of Ostrovsky et al (US 8,465,420).
Regarding claim 1, Kovac steerable arm (fig 6) for fitting into the instrument channel of an endoscope (capable of such) for use in endoscopic surgical procedures, comprising: a continuum structure (fig 17) in the form of a tubular member; the tubular member having a proximal end and a distal end (fig 17) and at least two sections (including unsegmented proximal length in fig 17 and ribs 232/234 distal of said length); (the) distal end suitable for being fitted with a surgical end effector (such as 140, fig 6); the tubular member being made of a resilient material (Col.9 ll 55-59); and a wire 278 extending inside the tubular member from the proximal end (fig 17); each wire affixed to the distal end of each section (fig 17), the distal end of the most distal section being the distal end of the tubular member (fig 17); each section capable of having a curvature lengthwise of the tubular member (fig 17), such that curvature of each section is changed when the distal end of each section is pulled on by the respective wire (fig 17), wherein the resilience of the material providing the tubular member with a bias such that the curvature change of each section is reversed reverses when the pull on the distal end is released (Col.9 ll 58-59).
While Kovac substantially discloses the invention as claimed, it does not disclose more than one wire, and thus does teach each section having its own wire attached to the distal end (see how claim is considered indefinite), and thus not a respective number of wires extending inside the tubular member from the proximal end; each wire affixed to the distal end of each section, the distal end of the most distal section being the distal end of the tubular member; each section capable of having a curvature lengthwise of the tubular member, such that curvature of each section is changed when the distal end of each section is pulled on by the respective wire, wherein the resilience of the material providing the tubular member with a bias such that the curvature change of each section is reversed reverses when the pull on the distal end is released; and the change of curvature of each of the at least two sections lies in a different plane.
Ostrovsky discloses a steerable device which embodiments which are only steerable in one plane (fig 2) or alternative embodiments which have two sections (258 and 260) which have their own control wires and which change the curvature in different planes.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Kovac such that it has a respective number of wires extending inside the tubular member from the proximal end; each wire affixed to the distal end of each section, the distal end of the most distal section being the distal end of the tubular member; each section capable of having a curvature lengthwise of the tubular member, such that curvature of each section is changed when the distal end of each section is pulled on by the respective wire, wherein the resilience of the material providing the tubular member with a bias such that the curvature change of each section is reversed reverses when the pull on the distal end is released; and the change of curvature of each of the at least two sections lies in a different plane as taught by Kovac to allow greater control over the curvature of the distal end of the device.
Regarding claim 15, (see 112 rejection above) wherein the steerable arm is placed at the distal end of a transmission tube (fig 6); the transmission tube containing a channel in which the wire is threaded (fig 1); the proximal end of the wires connected to knobs and/or levers 12/14 for pulling on the wire (fig 1); such that the curvature changes when the distal end of the tubular member is pulled on by the wire at the proximal end of the transmission tube (fig 17).
Regarding claim 16, wherein the surgical end effector is forceps 140 (although shown by reference, claim is mostly intended use).
Claim(s) 2-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovac et al (US 6,171,316) in view of Ostrovsky et al (US 8,465,420) and Besselink (US 2020/0038630).
Regarding claim 2, while Kovac substantially discloses the invention as claimed, it does not disclose wherein the tubular member has a first side and a second side along an axis of the tubular member; the first side being relatively more compressible than the second side; the second side being relatively less compressible compared to the first side; wherein the side of the tubular member that the wire is attached is the first side; and a pull on the wire compresses the first side to change the curvature of the tubular member.
Besselink discloses a steerable device where the tubular member has a first side and a second side along an axis of the tubular member; the first side being relatively more compressible than the second side (figs 5, 6 and 8); the second side being relatively less compressible compared to the first side (fig 8, due to more material); wherein the side of the tubular member that the wire is attached is the first side; and a pull on the wire compresses the first side to change the curvature of the tubular member (¶34). The configuration provides both flexibility and steerability while preserving the structural rigidity necessary to ensure the reliable, repeatable correlation between controlling movement at one elongate end of the device and rotational movement at the opposing end of the device (¶28).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Kovac such that the tubular member has a first side and a second side along an axis of the tubular member; the first side being relatively more compressible than the second side; the second side being relatively less compressible compared to the first side; wherein the side of the tubular member that the wire is attached is the first side; and a pull on the wire compresses the first side to change the curvature of the tubular member as taught by Besselink to provide both flexibility and steerability while preserving the structural rigidity necessary to ensure the reliable, repeatable correlation between controlling movement at one elongate end of the device and rotational movement at the opposing end of the device
Regarding claim 3, further comprising gaps in the first side to provide the compressibility of the first side; wherein the pull of the wire changes the curvature of the tubular member by bringing gaps closer and bending the second side towards the first side (fig 17 of Kovac, also see combination in claim 3 and figs 5 and 6 of Besselink).
Regarding claim 4, while Kovac substantially discloses the invention as claimed, it does not disclose wire guides inside the tubular member for guiding the translation of the wire.
Ostrovsky discloses wire channels disposed on the inner surface of the sections (Col.6 ll 30-38).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Kovac with wire guides inside the tubular member for guiding the translation of the wire as taught by Ostrovsky to prevent the wire from becoming caught on something.
Regarding claim 5, while Kovac substantially discloses the invention as claimed, it does not disclose wherein the tubular member is curved in a rest state, such that there is a concave side and a convex side to the tubular member; and the convex side of the tubular member being the first side.
Kovac discloses the preselected configured the tube naturally reverts to “such as a relatively straight configuration” (Col.9 ll 49-52), such that one of ordinary skill in the art would consider other shapes that re not straight, including the state the device is intended to assume - a concave side and a convex side to the tubular member; and the convex side of the tubular member being the first side as seen in fig 17 of Kovac and fig 6 of Besselink.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Kovac such that the tubular member is curved in a rest state, such that there is a concave side and a convex side to the tubular member; and the convex side of the tubular member being the first side as suggested by Kovac itself so that it requires less effort to have the device assume its intended shape.
Regarding claim 6-9, while Kovac substantially discloses the invention as claimed, it does not disclose wherein the tubular member is a tubular coil of spiraling loops providing the two sections; the curvature of the tubular member being such that the edges of the loops on the first side are spaced apart to provide the gaps; and the edge of each of the loops on the second side abutting the edge of each adjacent loop; wherein the first side and the second side are on opposite sides of the tubular member. Nor wherein the loops have different spiral pitches and/or spacing variations along different parts of the steerable arm, in order to provide the different parts with different flexibility, the loops are produced by at least one spiral cut made to a tube, or a slit in the edge of at least one of the loops on the second side.
As discussed in claim 2, Besselink provides an alternative shape with advantages. The alternative shape, in addition to the limitations in claim 2, also has the following features: the tubular member is a tubular coil of spiraling loops providing the two sections; the curvature of the tubular member being such that the edges of the loops on the first side are spaced apart to provide the gaps; and the edge of each of the loops on the second side abutting the edge of each adjacent loop; wherein the first side and the second side are on opposite sides of the tubular member (fig 5). Besselink also teaches wherein the loops have different spiral pitches and/or spacing variations along different parts of the steerable arm, in order to provide the different parts with different flexibility (¶37), the loops are produced by at least one spiral cut made to a tube (fig 5), and a slit in the edge of at least one of the loops on the second side (fig 5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Kovac such that the tubular member is a tubular coil of spiraling loops providing the two sections; the curvature of the tubular member being such that the edges of the loops on the first side are spaced apart to provide the gaps; and the edge of each of the loops on the second side abutting the edge of each adjacent loop; wherein the first side and the second side are on opposite sides of the tubular member; wherein the loops have different spiral pitches and/or spacing variations along different parts of the steerable arm, in order to provide the different parts with different flexibility, the loops are produced by at least one spiral cut made to a tube, and a slit in the edge of at least one of the loops on the second side as taught by Besselink to provide both flexibility and steerability while preserving the structural rigidity necessary to ensure the reliable, repeatable correlation between controlling movement at one elongate end of the device and rotational movement at the opposing end of the device.
Response to Arguments
Pages 8-12 of the arguments do not have any specific arguments but seem to be summarizing the invention.
Applicant argues on page 13 that there is neither usage or discussion of an endoscope to provide a surgical instrument with re-useable access into a body nor mention of steerable arms intended for the tip of an endoscope in Kovac. As the device of Kovac is a tubular device that is used for endoscopic procedures (title/abstract), and has the form of one based on the figures, the examiner maintains that said device is capable of use as claimed.
Applicant argues on pages 13 and 14 that there is no disclosure of any steerable arm having two bends, each capable of flexing in a different plane. The examiner doesn’t disagree with this. The claim is novel over Kovac, but the rejection is a 103 over Kovac and Ostrovsky, and Ostrovsky provides for the missing limitation)
On page 14, Applicant argues Kovac provides no reference to the skilled reader for improved cooperation and use of an endoscope in an endoscopic surgery and thus should be dismissed from consideration by the examiner. The examiner disagrees the pending claims are apparatus/device claims and as per MPEP 2114(II) an apparatus/device claim covers what a device is, not what a device does. As the reference has all the claimed structures and arranged as claimed, it meets the claimed limitations and thus the rejection is maintained.
On pages 14 and 15, Applicant discusses Ostrovsky and that the claims are novel over Ostrovsky. Again, the examiner does not disagree, only maintains that the rejection is Kovac in view of Ostrovsky. Applicant also states Ostrovsky is not a continuum structure, said limitation is provided for by primary reference Kovac. Applicant argues the assembly devices cannot be heated into retaining or memorizing any bend, which is not required by any claim language for which Ostorvsky is relied. That Ostrovsky cannot possibly disclose any pre-bent sections in the arm, which is not claimed, and even if it was Kovac would be relied upon for said limitation. Applicant argues Ostrovsky does not disclose “two bending sections which both bend in the same plane and not different planes”, the examiner does not see the relevance as that is neither claimed nor what Ostrovsky is being relied upon. Ostrovsky was cited as having a setup which bends in only one plane (establishing a link with Kovac as Kovac only bends in one plane) but that it also teaches bending in different planes (which IS claimed). Thus making it obvious to combine Kovac and Ostrovsky for the purpose of giving Kovac the ability to bend in an additional plane.
On pages 15 and 16, Applicant discusses Besselink and that it cannot provide the purportedly missing elements from claim 1. The examiner does not disagree, Besselink was not used for the rejection of claim 1.
Applicant argues on page 16 that claim 1 is not taught or suggested by Kovac in view of Ostrovsky. The examiner disagrees. Applicant has attacked the references individually, not the combination of references. Every limitation is covered by one of the references cited.
Applicant argues with respect to the 112 of claim 1 that “when read as a whole, and in light of subsequent recitation that curvature of each section is changed when the distal end of each section is pulled on by the respective wire” that one of ordinary skill in the art would understand the other parts of the claim and that each wire is paired in a one-by-one pairing. The examiner is not persuaded. While a claim is interpreted in light of the specification, it is not read into the claims. For example, the “respective number of wires” could be associated with the surgical end effector and still otherwise be arranged as claimed. It simply is not clear from the claims that “a respective number of wires” is respective with respect to the sections. Further, Applicant is arguing that “each wires affixed to the distal end of each section,” should be read in a more convoluted manner than stated, which is counter-intuitive and unclear.
With respect to the 112 rejection of claim 15, Applicant argues the claim only recites structural elements and functional recitation, not a step actively performed by a user or practitioner. The examiner maintains the rejection. Applicant is requiring structures not part of the steerable arm (a transmission tube) and a use of placing the claimed steerable arm at the end of the transmission tube. This is a use/method step.
Applicant has overcome the 112 rejection of claim 16
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
