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 .
Status of Claims
Claims 22-40 are pending, claims 1-21 and 41-60 have been cancelled, and claims 22-40 are currently under consideration for patentability under 37 CFR 1.104.
Election/Restrictions
Applicant’s election without traverse of Group 1, readable on claims 22-40, in the reply filed on 08/03/2026 is acknowledged.
Claim Objections
Claim 22 is objected to because of the following informalities: on line 5, change “or the elongate flexible member” to “of the elongate flexible member”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a rigidizing device” in claim 35.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 22-26, 28, 30-31, 34, 36-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319), in view of Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393).
Regarding claim 22, Martone discloses an external working channel assembly (100, figure 1a), the assembly comprising: an elongate, flexible member (receive an endoscope [0049]); a core region (108, figure 1a) extending over an outer surface of an elongate, flexible member (endoscope is within 102, figure 1b), wherein the core region is coupled to the outer surface of the elongate flexible member at a proximal end region of the elongate flexible member (ring 158 holds outer sheath 108 in place [0077], see figure 2b), and an external working channel (112, figure 1b) extending along an outer surface of the core region (see figures 1), wherein the external working channel is configured to accommodate a tool inserted through the external working channel (introducing tools…[0049]). Martone is silent regarding the core region is coupled to the outer surface of the elongate flexible member at a distal end region or the elongate flexible member; but is not secured to the elongate flexible member between the distal end region and the proximal end region; a coefficient of friction between core region and the outer surface of the elongate flexible member is between 0.3 and 1 to prevent bunching of the core region and external working channel when operating the assembly.
Avitsian teaches an endoscope sheath (100, figure 1) placed on an endoscope (102, figure 1). An elastic band can hold the distal sheath end tightly around the endoscope ([0038]).
Stefanchik teaches a sheath (200, figure 1) with a coefficient of friction which is suitable for gripping the endoscope with the sheath ([0089]). The inner surface can have a coefficient of static friction and coefficient of sliding friction between 0.3 and about 0.6 ([0089]). The sheath is formed of a polymeric film material ([0082]).
It would have been obvious to modify the assembly with an elastic band at the distal end of the core region as taught by Avitsian ([0038]). Doing so would hold the distal end of the core region to the elongate flexible member ([0038]). It also would have been obvious to modify the assembly to have a coefficient of friction between the core region and the outer surface of the elongate flexible member through the sheath being formed of a polymeric film material ([0082]) as taught by Stefanchik. Doing so would provide a sheath that is suitable for gripping the endoscope ([0089]). The modified assembly would have the core region is coupled to the outer surface of the elongate flexible member at a distal end region or the elongate flexible member (elastic band holding the distal sheath end tightly around the endoscope [0038]; Avitsian); but is not secured to the elongate flexible member between the distal end region and the proximal end region (elastic band holding the distal sheath end tightly around the endoscope [0038]; Avitsian | ring 158 is at proximal end 250 of an endoscope assembly [0077]; Martone | interpreted the rest of the core region is not secured); a coefficient of friction between core region and the outer surface of the elongate flexible member is between 0.3 and 1 (coefficient of friction between 0.3-0.6 [0089]; Stefanchik) to prevent bunching of the core region and external working channel when operating the assembly (suitable for gripping…[0089]).
Regarding claim 23, Stefanchik further teaches the coefficient of friction is between 0.4 and 1 (coefficient of friction between 0.3-0.6 [0089]; Stefanchik).
Regarding claim 24, Martone further discloses the external working channel is formed of one or more non-elastic filaments (strands…non-elastic…Teflon [0066]; Martone).
Regarding claim 25, Martone further discloses the external working channel comprises a plurality of pore openings (see pores between 204 and 206, figure 2a; Martone) formed by the one or more non-elastic filaments (strands…non-elastic…Teflon [0066]) and configured to change dimension as the one or more non-elastic filaments slide over each other (see figure 1b vs. 1c).
Regarding claim 26, Martone further discloses the external working channel is knitted or braided (braided tube 114 [0050]; Martone).
Regarding claim 28, Martone further discloses the one or more non-elastic filaments comprises one of: polytetrafluoroethylene (PTFE) (Teflon [0066]; Martone | Teflon is the brand name for PTFE), polyester, ultra-high-molecular-weight polyethylene (UHMWPE), high density polyethylene (HDPE), and polypropylene.
Regarding claim 30, Martone further discloses the core region is formed of one or more filaments (strands…non-elastic [0066] | braided tube 114…within the volume between sheaths 102 and 108 [0050]; Martone | interpreted the filaments to be within the core region 108; see figure 1b).
Regarding claim 31, Martone further discloses the core region is formed of at least some of the filaments of the one or more filaments forming the external working channel (strands…non-elastic [0066] | braided tube 114…within the volume between sheaths 102 and 108 [0050]; Martone | interpreted the filaments to be within the core region 108; see figure 1b).
Regarding claim 34, Martone further discloses the elongate, flexible member comprises an endoscope (receive an endoscope [0049]) or an overtube.
Regarding claim 36, Martone further discloses the core region and the external working channel comprises a multi-lumen braid (strands…non-elastic [0066] | braided tube 114…within the volume between sheaths 102 and 108 [0050]; Martone | interpreted the filaments to be within the core region 108; see figure 1b).
Regarding claim 37, Martone further discloses the core region and the external working channel comprises horizontal knit (see how 204 and 206 horizontally crossover one another, figure 2a; Martone).
Regarding claim 39, Martone further discloses the external working channel comprises a lubricious coating (coated…enhance lubricity [0054]; Martone).
Claim(s) 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 24 above, and further in view of Mazur et al. (2021).
Regarding claim 27, Martone further discloses the one or more non-elastic filaments comprise a plastic material (Teflon or PTFE [0066]; Martone). They are silent regarding the plastic material having a modulus of elasticity of greater than 50,000 psi.
Mazur et al. teaches PTFE has a Young’s Modulus of 766 ± 29 MPa (Table 2, pg. 6).
It would have been obvious to modify the assembly, specifically the one or more non-elastic filaments, to be made of PTFE as taught by Mazur. Doing so would provide a material with a flexible nature (pg. 5, Section 3.2) and that has a Young’s Modulus of 766 ± 29 MPa (Table 2, pg. 6). The modified assembly would have the plastic material having a modulus of elasticity of greater than 50,000 psi (766 ± 29 MPa; Table 2, pg. 6 | 766 MPa -> 111,099 psi).
Regarding claim 29, Martone further discloses the one or more non-elastic filaments comprise a plastic material (Teflon or PTFE [0066]; Martone). They are silent regarding the plastic material having a coefficient of friction of 0.5 or less.
Mazur et al. teaches PTFE is characterized by a low friction coefficient below 0.1 (pg. 1; Introduction).
It would have been obvious to modify the assembly, specifically the one or more non-elastic filaments, to be made of PTFE as taught by Mazur. Doing so would provide a polymer material with high molecular cohesion that is characterized by high chemical/corrosion resistance, low friction coefficient, and has a wide operating temperature range (pg. 1; Introduction). The modified assembly would have the plastic material having a coefficient of friction of 0.5 or less (0.1; pg.1 in Introduction of Mazur et al.).
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 22 above, and further in view of Lombardi (US 2017/0035276).
Regarding claim 32, Martone and Avitsian and Stefanchik disclose all of the features in the current invention as shown above in claim 22. They are silent regarding a plurality of external working channels extending along the outer surface of the core region.
Lombardi teaches a disposable sheath device (10, figure 1a) with a primary lumen (12, figures 1) and a secondary lumen (17, figures 1). The secondary lumen expands from a collapsed position to full height when a tool device is inserted into the lumen as needed ([0053]). It is desirable for the secondary lumen sheath material to be flexible and to stretch to expand radially to accommodate tools having an exterior diameter slightly larger than the interior diameter of the secondary lumen ([0057]). Multiple secondary lumens can be attached to the primary lumen to accommodate the use of more than one tool device simultaneously ([0098]).
It would have obvious to modify the assembly to have multiple external working channels as taught by Lombardi ([0098]). Doing so would accommodate the use of more than one tool device simultaneously ([0098]). The modified assembly would have a plurality of external working channels (multiple secondary lumens [0098]; Lombardi) extending along the outer surface of the core region (see 17, figure 1c; Lombardi).
Claim(s) 33 is rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 22 above, and further in view of Blumenkranz (US 2007/0151390).
Regarding claim 33, Martone and Avitsian and Stefanchik disclose all of the features in the current invention as shown above in claim 22. They are silent regarding the external working channel is configured to have an anisotropic stretch profile with a lower hoop stretch than an axial stretch.
Blumenkranz teaches an anisotropic linear fiber reinforced polymer tubing applied to surgical instruments ([0041]). This allows for constant and easily characterized elastic properties ([0041]).
It would have been obvious to modify the assembly, specifically the external working channel, to have an anisotropic linear fiber reinforced polymer tubing as taught by Blumenkranz ([0041]). Doing so would provide constant and easily characterized elastic properties ([0041]). The modified assembly would have the external working channel is configured to have an anisotropic stretch profile with a lower hoop stretch than an axial stretch (anisotropic linear…tubing…[0041]; Blumenkranz).
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 22 above, and further in view of Okaniwa (US 2018/0263469).
Regarding claim 35, Martone and Avitsian and Stefanchik disclose all of the features in the current invention as shown above in claim 22. They are silent regarding the elongate, flexible member comprises a rigidizing device.
Okaniwa teaches an endoscope system (50, figure 1) with an endoscope (1, figure 1) and an overtube (40, figure 1). The endoscope has a flexible tube portion (10, figure 3) and an operation section (3, figure 1). The operation section (3, figure 1) has a rigidity changing knob (21, figure 1) for operating a rigidity changing mechanism portion (20, figure 3). The rigidity changing mechanism portion changes rigidity of the flexible tube portion (10, figure 3) to flexion ([0030]). The rigidity changing mechanism (20, figure 3) includes a coil pipe (22, figure 3), a first wire (24, figure 3), a second wire (25, figure 3), and a pulling mechanism portion (30, figure 3). When a compressive force is applied to the coil pipe according to the tension applied by the pulling mechanism, resistance force of the coil pipe to bending deformation is increasing ([0039]).
It would have been obvious to modify the assembly to be used with the endoscope (1, figure 1) that has a rigidity changing knob (21, figure 1) and a rigidity changing mechanism portion (20, figure 3) of Okaniwa. Doing so would provide an endoscope where the rigidity of a flexible tube portion can be changed ([0030]). The modified assembly would have the elongate, flexible member comprises a rigidizing device (this element is interpreted under 35 USC 112f as a plurality of layers that can transition from a flexible to a rigid configuration through pressure or jamming particles, phase change, shape memory alloys, interlocking components, EAP or any other rigidizing mechanism [0173] | see 20, figure 3; Okaniwa).
Claim(s) 38 is rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 22 above, and further in view of Gafford (US 2023/0371795).
Regarding claim 38, Martone and Avitsian and Stefanchik disclose all of the features in the current invention as shown above in claim 22. They are silent regarding a matched pair of tools configured to be inserted together through the external working channel, wherein a first tool of the pair of tools comprises a steerable distal end configured to steer a second tool of the pair of distal tools as it exits the external working channel.
Gafford teaches a surgical system (10, figure 1) with an endoscope (30, figure 1). A steerable sheath (50, figure 1) is introduced through a working port (38, figure 1) of the endoscope ([0064]). A surgical tool (70, figure 1) can be passed through the sheath to access the surgical site ([0064]). The sheath (50, figure 1) is steered remotely from a proximal end of the endoscope via an external controller (not shown; [0064]).
It would have been obvious to modify the assembly to use a sheath (50, figure 1) and surgical tool (70, figure 1) that can be inserted through the external working channel as taught by Gafford. Doing so would provide a surgical tool (and sheath) that can be steered to a desired position and orientation outside the external working channel ([0064]). The modified assembly would have a matched pair of tools (50 and 70, figure 1; Gafford) configured to be inserted together through the external working channel (modified assembly can have 50 and 70 inserted through the external working channel), wherein a first tool (50, figure 1) of the pair of tools comprises a steerable distal end (52, figure 1) configured to steer a second tool (70, figure 1) of the pair of distal tools as it exits the external working channel ([0064]).
Claim(s) 40 is rejected under 35 U.S.C. 103 as being unpatentable over Martone (US 2007/0088319) and Avitsian (US 2015/0031955) and Stefanchik (US 2007/0203393) as applied to claim 22 above, and further in view of Hadani (US 2012/0089028).
Regarding claim 40, Martone and Avitsian and Stefanchik disclose all of the features in the current invention as shown above in claim 22. They are silent regarding a deflector at a distal end of the external working channel configured to defect a tool extending from a distal end of the external working channel radially away from the distal end of the elongate, flexible member.
Hadani teaches a device (300, figure 3) including a catheter (102, figure 2) and a sheath channel (302, figure 3). A tool deflector (206, figure 3) controls an orientation of an endoscopic tool (204, figure 3).
It would have been obvious to modify the assembly with a deflector (206, figure 3) and sheath channel (302, figure 3) at the distal end of the external working channel as taught by Hadani. Doing so would control the orientation of the tool ([0061]). The modified assembly would have a deflector (206, figure 3; Hadani) at a distal end of the external working channel (see figure 3) configured to defect a tool (204, figure 3) extending from a distal end of the external working channel radially away from the distal end of the elongate, flexible member (see figure 3; [0061]).
Conclusion
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PAMELA F. WU
Examiner
Art Unit 3795
August 22, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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