DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 04/02/2026. As indicated by the amendment: claims 1-2 and 4-7 have been amended. In response to the amendments of claims 1-2, 4-7 and 10, their rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Non-Final Office action of 01/02/2026 have been withdrawn. Claims 1-10 are presently pending in the application and are examined below.
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 1-10 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.
Amended independent claim 1 recites, in pertinent part, the first shaft and second shaft secured by a flexible material, wherein the flexible material comprises a tubular structure disposed between the first shaft and second shaft, wherein the second shaft comprises an outer layer and an inner layer of the flexible material. The claim recites that the flexible material is a tubular structure that is disposed between the first and second shaft segments. It also recites that the second shaft comprises an outer layer and an inner layer of the flexible material. The structure of the shaft is not clear from the claim language. It is not clear how “the flexible material” that is a tubular structure is both disposed between the first and second shaft segments and comprises the layers of the second shaft. It is not clear if the flexible material that is disposed between the first and second shaft segments is the same flexible material that comprises the inner and outer layers of the second shaft segment. Does the tubular structure of the flexible material comprise one layer or two layers? Accordingly, the claim is rendered indefinite. Appropriate correction is required.
Dependent claim 2 recites that the flexible material may be a flexible intermediate tube. The use of the phrase “may be” does not provide definiteness to the claim as it could be a flexible intermediate tube or it could be something else. Further, amended independent claim 1 recites that the flexible material is a tubular structure. It is not clear how, or if, the flexible intermediate tube is different than the tubular structure recited in independent claim 1. Accordingly, the claim is rendered indefinite. Appropriate correction is required. For purposes of examination, the flexible intermediate tube is interpreted as being the same as the tubular structure recited in independent claim 1.
Dependent claim 3 recites that the first shaft and second shaft are secured by a flexible material. Amended independent claim 1 recites that the first shaft and second shaft are secured by a flexible material. Thus, the language of claim 3 suggests that an additional flexible material also secures the first and second shafts. The structure of the shaft comprising a second flexible material is not clear. Accordingly, the claim is rendered indefinite. For purposes of examination, “a flexible material” of claim 3 is interpreted as being the same flexible material of claim 1.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2022/0133138 A1) in view of Takahashi (US 2012/0180896 A1) in view of Yamashita (US 2015/0305598 A1).
Regarding claim 1, Lin discloses an articulating cannula (10; Fig. 1a) comprising: a proximal end (Fig. 1a; 14) and a distal end (Fig. 1a; 18), the distal end configured to articulate between a first position and a second position (par. [0022]); and a hollow tubular shaft (12; Fig. 1a) connecting the proximal end (at 14) and the distal end (18), the shaft (12) being segmented into a first shaft (more rigid/less flexible proximal portion; par. [0018]) and a second shaft (less rigid/more flexible distal portion; par. [0018]), wherein the proximal end (14) comprises of a housing (housing of 14; Fig. 1a) having diameter substantially greater than the diameter of the shaft (12; Fig. 1a), and configured to allow insertion of an articulating surgical endoscope (capable of such intended use; see Fig. 2b), wherein the second shaft (less rigid/more flexible distal portion; par. [0018]) comprises of an outer layer (par. [0017]-[0018] – when 12b is disposed between layers of flexible tubular plastic material 12a) and an inner layer (par. [0017]-[0018] – when 12b is disposed between layers of flexible tubular plastic material 12a) of the flexible material with a spring (12b; par. [0017]-[0018]) [[in]] between the outer layer and inner layer (par. [0018] – “coil 12b can be embedded in the plastic material wall of tube 12a or can be between layers of plastic material”), wherein the second shaft (less rigid/more flexible distal portion; par. [0018]) configured to facilitate the articulation of the distal end (par. [0022]),
However, Lin does not specifically disclose the first and second shaft secured by a flexible material, wherein the flexible material comprises a tubular structure disposed between the first shaft and the second shaft. Takahashi teaches an analogous device wherein the shaft varies in flexibility, like that of Lin, with a first shaft portion (proximal portion having resin layer 18; par. [0034]; Fig. 2), a second shaft portion (distal portion having resin layer 17; par. [0034]; Fig. 2), and a flexible material comprising a tubular structure (central portion comprising both resin layers 17 and 18; par. [0034]; Fig. 2) disposed between the first shaft (proximal portion having resin layer 18) and the second shaft (distal portion having resin layer 17). Takahashi teaches that the first shaft portion is more rigid/less flexible and the second shaft portion is less rigid/more flexible (par. [0037]). Takahashi teaches that the tubular structure of the flexible material (central portion comprising both resin layers 17 and 18; par. [0034]; Fig. 2) is a transitional area where the flexibility of the shaft changes from more flexible to more rigid in the proximal direction. Takahashi teaches forming the shaft having the variable flexibility using extrusion molding of the outer layers (17 and 18) and a covering layer (15; par. [0014]-[0015]). Takahashi teaches that the covering layer (15) secures both good molding precision and hardness difference between the distal and proximal sides of the shaft (par. [0014]). It would have been obvious to one having ordinary skill in the art to modify the outer layers of Lin with resins having different hardnesses and with a covering layer, as taught by Takahashi, thereby providing the variable flexibility shaft, contemplated by Lin, with materials for the desired flexibility of the first and second shafts, and a flexible material that is a tubular structure that is a transitional area where the flexibility of the shaft changes. Such modification also provides both good molding precision and hardness difference between the distal and proximal sides of the shaft, as taught by Takahashi.
Lin does not specifically disclose that the spring is a compression spring, wherein the compression spring is configured to cooperate with the outer layer and inner layer to resist radial collapse of the second shaft during articulation. Yamashita teaches an analogous device (Fig. 6) having a shaft (40; par. [0041]) that uses a compression spring (60; par. [0041]) for passive bending of the shaft (par. [0024]). It would have been obvious to one having ordinary skill in the art to substitute the compression spring of Yamashita for the coil between the outer and inner layers in the cannula of Lin to provide passive bending as taught by Yamashita and contemplated by Lin. Such modification provides a configuration wherein the compression spring is configured to cooperate with the outer layer and inner layer (par. [0018] – “coil 12b can be embedded in the plastic material wall of tube 12a or can be between layers of plastic material”) to resist radial collapse of the second shaft during articulation (capable of such functioning due to presence of compression spring between the outer and inner layers of the shaft).
Regarding claim 2, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein the flexible material may be a flexible intermediate tube
Regarding claim 3, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein the first shaft and the second shaft are secured by a flexible material using at least one of an ultrasonic or over-mould type of sealing (Takahashi: par. [0018] – extrusion molding).
Regarding claim 4, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, but does not specifically disclose wherein the flexible material comprises at least one of Viton, Silicon, or natural rubbercannula, and applicant’s invention, to perform equally well with either the material taught by modified Lin or the claimed Viton, Silicon or natural rubber materials because both materials would perform the same function of connecting the shaft segments. Therefore, it would have been prima facie obvious to modify Lin to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of modified Lin.
Regarding claim 5, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein material utilized to make the spring comprises at least one of a Stainless steel (Yamashita: par. [0041]), Music wire, or Plastic
Regarding claim 6, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein articulation of the distal end is configured to articulate up to 90° any plane about 360° (the passive bending shaft is capable of bending in any direction that force is applied).
Regarding claim 7, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein the articulating endoscope may be an instrument with articulating tip associated with one or more surgical tasks, such as a forceps, a needle driver, a shears, a bipolar cauterizer, a tissue stabilizer or retractor, a clip applier, an anastomosis device, an imaging device, an endoscope, or an ultrasound probenot a claimed structural component of the articulating cannula; the articulating cannula of Lin is capable of having such an endoscope inserted therethrough).
Regarding claim 8, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein the spring (12b; Yamashita: 60) helps to maintain remote center of motion (RCM) with patient body in a surgical robotic system (capable of such intended use).
Regarding claim 9, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein spacing between the outer layer and the inner layer can be between 2.2 mm to 28 mm (par. [0021]).
Regarding claim 10, Lin in view of Takahashi in view of Yamashita disclose the articulating cannula as claimed in claim 1, wherein the articulating endoscope (318) comprises of a proximal end connected with a distal end by an endoscope shaft (the articulating endoscope is not a claimed structural component of the articulating cannula; the articulating cannula of Lin is capable of having such an endoscope inserted therethrough).
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive. Applicant contends that Lin does not disclose any spring positioned between inner and outer layers (see pages 8 and 9 of the Remarks filed 04/02/2026). The Examiner respectfully disagrees. As discussed above Lin discloses the “coil 12b can be embedded in the plastic material wall of tube 12a or can be between layers of plastic material” (see par. [0018]). As is clear, Lin discloses a spring (coil 12b) that is disposed between inner and outer layers as it is located between layers of plastic materials. Applicant next argues that neither Takahashi and Yamashita cure the alleged deficiencies of Lin (see pages 9-10 of the Remarks filed 04/02/2026). The Examiner asserts that neither Takahashi nor Yamashita are used for or needed to cure the alleged deficiency of Lin. As is clear from the above disclosure, Lin discloses a spring disposed between layers. Takahashi and Yamashita are used to teach other features of the claimed device. As it is clear that Lin discloses a spring that is disposed between inner and outer layers, the rejection is maintained. The Examiner recommends clarifying the claimed structure of the cannula and/or adding additional structure of the cannula to overcome the prior art.
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.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/17/26
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