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 .
Response to Amendment
The amendment filed on 6/27/2025 has been entered. Claims 1-9, 15-20, and 22-26 remain pending in the application. Claims 8-9 remain withdrawn. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed April 14th, 2025.
Response to Arguments
Applicant’s arguments, see pages 3-5, filed 6/27/2025, with respect to claim 1, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejections identified in the non-final dated 4/14/2025 moot, and require a new ground of rejection.
Therefore, the 102 rejections previously identified in the non-final action dated 4/14/2025 have been withdrawn.
Applicant’s arguments, see pages 5-10, filed 6/27/2025, with respect to claims 1 and 15, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejections identified in the non-final dated 4/14/2025 moot, and require a new ground of rejection.
Therefore, the 103 rejections previously identified in the non-final action dated 4/14/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Claim Objections
Claims 23 and 25 are objected to because of the following informalities:
In claim 23, lines 1-2 and claim 25, lines 1-2, “the plurality of first guides extend” should read “the plurality of first guides extends.”
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 limitations are: “an insertion portion configured to be inserted into a subject” in claims 1 and 15, and “a guided portion … engaged with the plurality of first guides” in claim 15.
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.
The specification discloses in paragraph 0018 that the “insertion portion” is an insertion tube. The language in claims 1 and 15 will be interpreted as requiring the disclosed structure in paragraph 0018, or equivalents.
The specification discloses in paragraph 0039 that the “guided portion” is a trench fitted to a rail. The language in claim 15 will be interpreted as requiring the disclosed structure in paragraph 0039, or equivalents.
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
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.
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.
Claims 1-3, 5, 15-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2004/0230096 A1 to Stefanchik et al. (hereinafter “Stefanchik ‘096”) in view of U.S. Patent Appl. Publ. No. 2008/0132758 A1 to Stefanchik et al. (hereinafter “Stefanchik ‘758”) and further in view of U.S. Patent Appl. Publ. No. 2008/0033241 A1 to Peh et al. (“Peh”).
Regarding claim 1, Stefanchik ‘096 discloses an endoscope (a sheath 80 surrounds endoscope 100 and rail 30; Fig. 6, paragraph 0065), comprising:
an insertion portion configured to be inserted into a subject (the endoscope 100 with rail 30 can then be inserted into the body of the patient; Fig. 4B, paragraph 0078);
a channel provided in the insertion portion (lumen of sheath 80; Fig. 6), the channel configured to receive an accessory (accessory 50 may be a working channel, through which instrument 168 may be introduced; Fig. 6, paragraph 0078); and
a first guide protruding from an inner surface of the channel and the first guide configured to guide the accessory along a longitudinal axis of the insertion portion (rail 30 can be joined to an inner surface of sheath 80. Such an embodiment allows passage of mating member 40 and accessory 50 within sheath 80; Fig. 6, paragraph 0065).
However, Stefanchik ‘096 does not explicitly teach breaking the first guide into segments and the plurality of first guide segments spaced apart at intervals in the channel.
Stefanchik ‘758 teaches a plurality of first guides spaced apart at intervals in the channel (a portion of sidewalls 672, 674, and the bottom of 676 of the track 632 can be omitted to form a gap 102. Multiple gaps of any length can also be included; Fig. 6, #102, paragraph 0032-0033). Stefanchik ‘758 teaches that the gaps allow the distal end of the accessory channel to derail from the sheath without compromising the integrity of the mating between the shaft and accessory channel (paragraph 0032).
Stefanchik ‘758 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with guiding systems for an accessory. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide rail of Stefanchik ‘096 to incorporate the teachings of Stefanchik ‘758 by adding gaps in the first guide rail. Doing so would allow the distal end of the accessory channel to derail from the sheath without compromising the integrity of the mating between the shaft and accessory channel, as recognized by Stefanchik ‘758.
Futhermore, Stefanchik ‘096 does not explicitly teach a housing at a distal end of the insertion portion, the housing including an image pick-up optical system, and the channel opening into the housing.
Peh teaches an insertion portion configured to be inserted into a subject (deployment catheter 16; Fig. 3B, paragraph 0050);
a housing at a distal end of the insertion portion (imaging hood 12 may be attached at interface 24 to a deployment catheter 16; Fig. 1B and 3B, paragraph 0044), the housing including an image pick-up optical system (an imaging element 64 (e.g. CCD, or CMOS electronic imager) may be placed along an interior surface of imaging hood 12 to provide imaging of the open area such that the imaging element 64 is off-axis relative to a longitudinal axis of the hood 12; Fig. 5B, paragraph 0054);
a channel provided in the insertion portion and opening into the housing (lumen of deployment catheter opens into the lumen of imaging hood 12; Fig. 5B), the channel configured to receive an accessory (an articulatable delivery catheter 48 … may be delivered through the deployment catheter 16 and into imaging hood 12; Fig. 3B, paragraph 0050).
Peh teaches that housing with an image pick-up optical system helps to provide direct visualization and uninhibited access by instruments from the catheter to the underlying tissue during treatment (paragraph 0054).
Peh is considered to be analogous to the claimed invention because it is in the same field of surgical insertion devices with a distal camera. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath of Stefanchik ‘096 to incorporate the teachings of Peh by adding the housing with an image pick-unit to the distal end of the sheath. Doing so would help to provide direct visualization and uninhibited access by instruments from the endoscope to the underlying tissue during treatment, as recognized by Peh.
Regarding claim 2, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. Stefanchik ‘096 further teaches wherein the accessory is a guide wire that guides a treatment instrument (other devices which can be provided as suitable accessories include, but are not limited to, a biopsy forceps, an articulating instrument, a surgical scissor, a device adapted for sewing or stapling tissue, a guidewire, a device adapted for liquid or gas injection, or a tissue ablation system; paragraph 0079).
Regarding claim 3, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. Stefanchik ‘096 further teaches wherein the accessory is a treatment instrument (other devices which can be provided as suitable accessories include, but are not limited to, a biopsy forceps, an articulating instrument, a surgical scissor, a device adapted for sewing or stapling tissue, a guidewire, a device adapted for liquid or gas injection, or a tissue ablation system; paragraph 0079).
Regarding claim 5, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. Stefanchik ‘096, as modified by Stefanchik ‘758, further teaches wherein the plurality of first guides is located on a first axis that is parallel to the longitudinal axis of the insertion portion (rail 30 runs along an axis that is parallel to the longitudinal axis of sheath; Fig. 2B).
Regarding claim 15, Stefanchik ‘096 discloses an endoscope system comprising an endoscope (a sheath 80 surrounds endoscope 100 and rail 30; Fig. 6, #80, paragraph 0065), and an accessory (accessory 50 can be in the form of a flexible tubular guide for receiving and guiding a medical instrument alongside an endoscope; Fig. 6, #50, paragraph 0036), wherein the endoscope includes:
an insertion portion configured to be inserted into a subject (the endoscope 100 with rail 30 can then be inserted into the body of the patient; Fig. 4B, paragraph 0078),
a channel provided in the insertion portion (lumen of sheath 80; Fig. 6), the channel configured to receive the accessory (accessory 50 may be a working channel, through which instrument 168 may be introduced; Fig. 6, #50, paragraph 0078), and
a first guide provided in the channel and configured to guide the accessory along a longitudinal axis of the insertion portion, and the first guides protruding from an inner surface of the channel (rail 30 can be joined to an inner surface of sheath 80. Such an embodiment allows passage of mating member 40 and accessory 50 within sheath 80; Fig. 6, #30, paragraph 0065), and
wherein the accessory includes:
a body configured to be inserted into the channel (accessory 50 can be in the form of a flexible tubular guide for receiving and guiding a medical instrument alongside an endoscope; Fig. 6, #50, paragraph 0036), and
a guided portion provided at the body (mating member 40 and accessory 50 can be formed as a unitary piece, or joined by any suitable attachment method; Fig. 6, #40, paragraph 0038) and engaged with the first guide (mating member 40 is operatively coupled to rail 30 through interlocking contours; Fig. 6, #40, paragraph 0037).
However, Stefanchik ‘096 does not explicitly teach breaking the first guide into segments and the plurality of first guide segments spaced apart at intervals in the channel.
Stefanchik ‘758 teaches a plurality of first guides spaced apart at intervals in the channel (a portion of sidewalls 672, 674, and the bottom of 676 of the track 632 can be omitted to form a gap 102. Multiple gaps of any length can also be included; Fig. 6, #102, paragraph 0032-0033). Stefanchik ‘758 teaches that the gaps allow the distal end of the accessory channel to derail from the sheath without compromising the integrity of the mating between the shaft and accessory channel (paragraph 0032).
Stefanchik ‘758 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with guiding systems for an accessory. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide rail of Stefanchik ’096 to incorporate the teachings of Stefanchik ‘758 by adding gaps in the first guide rail. Doing so would allow the distal end of the accessory channel to derail from the sheath without compromising the integrity of the mating between the shaft and accessory channel, as recognized by Stefanchik ‘758.
Furthermore, Stefanchik ‘096 does not explicitly teach a housing at a distal end of the insertion portion, the housing including an image pick-up optical system, and the channel opening into the housing.
Peh teaches an insertion portion configured to be inserted into a subject (deployment catheter 16; Fig. 3B, paragraph 0050);
a housing at a distal end of the insertion portion (imaging hood 12 may be attached at interface 24 to a deployment catheter 16; Fig. 1B and 3B, paragraph 0044), the housing including an image pick-up optical system (an imaging element 64 (e.g. CCD, or CMOS electronic imager) may be placed along an interior surface of imaging hood 12 to provide imaging of the open area such that the imaging element 64 is off-axis relative to a longitudinal axis of the hood 12; Fig. 5B, paragraph 0054);
a channel provided in the insertion portion and opening into the housing (lumen of deployment catheter opens into the lumen of imaging hood 12; Fig. 5B), the channel configured to receive an accessory (an articulatable delivery catheter 48 … may be delivered through the deployment catheter 16 and into imaging hood 12; Fig. 3B, paragraph 0050).
Peh teaches that housing with an image pick-up optical system helps to provide direct visualization and uninhibited access by instruments from the catheter to the underlying tissue during treatment (paragraph 0054).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath of Stefanchik ‘096 to incorporate the teachings of Peh by adding the housing with an image pick-unit to the distal end of the sheath. Doing so would help to provide direct visualization and uninhibited access by instruments from the endoscope to the underlying tissue during treatment, as recognized by Peh.
Regarding claim 16, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 15. Stefanchik ‘096 further teaches wherein the accessory is a guide wire that guides a treatment instrument (other devices which can be provided as suitable accessories include, but are not limited to, a biopsy forceps, an articulating instrument, a surgical scissor, a device adapted for sewing or stapling tissue, a guidewire, a device adapted for liquid or gas injection, or a tissue ablation system; paragraph 0079).
Regarding claim 17, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 15. Stefanchik ‘096 further teaches wherein the accessory is a treatment instrument (other devices which can be provided as suitable accessories include, but are not limited to, a biopsy forceps, an articulating instrument, a surgical scissor, a device adapted for sewing or stapling tissue, a guidewire, a device adapted for liquid or gas injection, or a tissue ablation system; paragraph 0079).
Regarding claim 18, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 15. Stefanchik ‘096 further teaches wherein the guided portion is disposed at a distal end portion of the accessory (guide system 20 can have a mating member 40 and a rail 30 either or both of which is substantially the same length as, or longer than the endoscope with which they are used; Fig. 2A, #40, paragraph 0047).
Regarding claim 19, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. Stefanchik ‘096 further teaches wherein, in a plane perpendicular to the longitudinal axis of the insertion portion, at least a portion of the plurality of first guides have a T-shape (rail 30 has a T-shaped cavity and mating member 40 is T-shaped; Fig. 6, #30 and #40).
Regarding claim 22, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. Stefanchik ‘096 further teaches wherein the guided portion has a length that is equal to or greater than 1.1 times the interval (embodiments of the guide system 20 of the present invention having a mating member 40 with a length that is greater than or substantially equal to the length of rail 30 and the insertion length of the endoscope provide an advantage over endoscopic systems using an engaging member that is not sustainably the same length as the track; Fig. 2AB-B, paragraph 0051). Stefanchik ‘096 teaches a guided portion that is equal to or greater than the length of the first guide without any gaps introduced by Stefanchik ‘758. It is understood that any gap introduced by Stefanchik ‘758 must have a length that is less than the length of the first guide. Therefore, the length of the guided portion must be equal to or greater than the length of the gap. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the guide portion of Stefanchik ‘096 from equal to or greater than the length of the gap to equal to or greater than 1.1 times the length of the gap since it has been held that “[i}n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 4, 20, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik ‘096 in view of Stefanchik ‘758 and Peh as applied to claims 1 and 15 above, and further in view of U.S. Patent Appl. Publ. No 2010/0268028 A1 to Ghabrial (“Ghabrial”).
Regarding claim 4, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. However, Stefanchik does not explicitly teach wherein the plurality of first guides includes a distalmost first guide, the distalmost first guide being located in a distal end portion of the insertion portion.
Ghabrial teaches wherein the plurality of first guides includes a distalmost first guide, the distalmost first guide being located in a distal end portion of the insertion portion (the tracks 360 can extend along any portion of the shaft 322 and/or the end cap 315. As in the illustrated embodiment, the tracks 360 can continuously extend along the substantially the entire longitudinal length of the proximal and distal portion 312, 314: Fig. 9-10, paragraph 0062). Ghabrial teaches that extending the first guide to the distal end portion of the insertion portion helps direct the surgical instrument through the end cap thereby helping distally direct surgical devices advanced through the device (paragraph 0061).
Ghabrial is considered to be analogous art to the claimed invention because it is in the same field of endoscopes with guiding systems for an accessory. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of first guides of Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, to incorporate the teachings of Ghabrial by extending the distalmost first guide to the distal end portion of the insertion portion. Doing so would help distally direct surgical devices advanced through the device, as recognized by Ghabrial.
Regarding claim 20, Stefanchik ‘096, as previously modified by Stefanchik ‘758, Peh, and Ghabrial, teaches the endoscope according to claim 1 and 4. Stefanchik ‘096 further teaches wherein, in a plane perpendicular to the longitudinal axis of the insertion portion, the distalmost first guide has a T-shape (rail 30 has a T-shaped cavity and mating member 40 is T-shaped; Fig. 6, #30 and #40).
Regarding claim 23, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 15. However, Stefanchik ‘096, as modified by Stefanchik ‘758 and Peh, does not explicitly teach wherein the plurality of first guides extends into the housing.
Ghabrial teaches wherein the first guide extends into the housing (the tracks 360 can extend along any portion of the shaft 322 and/or the end cap 315; Fig. 9-10, paragraph 0062). Ghabrial teaches that extending the first guide to the housing helps direct the surgical instrument through the housing thereby helping distally direct surgical devices advanced through the device (paragraph 0061).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of first guides of Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, to incorporate the teachings of Ghabrial by extending the first guide into the housing. Doing so would help distally direct surgical devices advanced through the device, as recognized by Ghabrial.
Regarding claim 25, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. However, Stefanchik ‘096, as modified by Stefanchik ‘758 and Peh, does not explicitly teach wherein the plurality of first guides extends into the housing.
Ghabrial teaches wherein the first guide extends into the housing (the tracks 360 can extend along any portion of the shaft 322 and/or the end cap 315; Fig. 9-10, paragraph 0062). Ghabrial teaches that extending the first guide to the housing helps direct the surgical instrument through the housing thereby helping distally direct surgical devices advanced through the device (paragraph 0061).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of first guides of Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, to incorporate the teachings of Ghabrial by extending the first guide into the housing. Doing so would help distally direct surgical devices advanced through the device, as recognized by Ghabrial.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik ‘096 in view of Stefanchik ‘758 and Peh as applied to claim 1 above, and further in view of 2007/0225555 A1 to Stefanchik (hereinafter “Stefanchik ‘555”).
Regarding claim 6, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. However, Stefanchik ‘096, as modified by Stefanchik ‘758 and Peh, does not explicitly teach wherein the insertion portion includes a bending portion, wherein the plurality of first guides is spaced apart at a first interval in the bending portion, wherein the plurality of first guides is spaced apart at a second interval in a portion of the insertion portion other than the bending portion, and wherein the first interval is greater than the second interval.
Stefanchik ‘555 teaches wherein the insertion portion includes a bending portion (track 300 can include a portion having a bending flexibility and axial flexibility that is greater than the bending flexibility and axial flexibility of another portion of the track; Fig. 3, Section B, paragraph 0103-0106),
wherein the plurality of first guides is spaced apart at a first interval in the bending portion (sections A and B are interrupted at intervals along their respective lengths to reduce the bending stiffness and the axial stiffness of the regions; Fig. 3, #340, Section B, paragraph 0104-0106),
wherein the plurality of first guides is spaced apart at a second interval in a portion of the insertion portion other than the bending portion (Sections A and B are interrupted at intervals along their respective lengths to reduce the bending stiffness and the axial stiffness of the regions; Fig. 3, #340, Section A, paragraph 0104-0106), and
wherein the first interval is greater than the second interval (the spacing 342 between the slits 340 on the same side of the track 300 can be about 0.120 to about 0.130 inch in Section A and about 0.250 inch in Section B; Fig. 3, #342, paragraph 0104-0106).
Stefanchik ‘555 is considered to be analogous to the claimed invention because it is in the same field of endoscopes with guiding systems for an accessory. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide of Stefanchik ‘096, as modified by Stefanchik ‘758 and Peh, to incorporate the teachings of Stefanchik ‘555 by spacing the first guides at two different intervals along the insertion portion. Doing so would help to allow the track to follow the curvature of the endoscope without significantly increasing the bending stiffness of the sheath and endoscope assembly, as recognized by Stefanchik ‘555.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik ‘096 in view of Stefanchik ‘758 and Peh as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No 2019/0282068 A1 to Bunch et al. (“Bunch”).
Regarding claim 7, Stefanchik ‘096, as previously modified by Stefanchik ‘758 and Peh, teaches the endoscope according to claim 1. However, Stefanchik ‘096 does not explicitly teach further comprising a tube in which the plurality of first guides is disposed, wherein the tube is provided in the channel.
Bunch teaches further comprising a tube in which the plurality of first guides is disposed (elongated jacket 140 extend coaxially around an outer surface of elongated body 110 and includes longitudinal track 170 extending from the distal end to the proximal end of elongated body 110; Fig. 6, #140, paragraph 0044), wherein the tube is provided in the channel (the mini-scope and clip are positioned within the lumen of access sheath 158; Fig 6, #158, paragraph 0050). Bunch teaches that providing the first guide in a tube within the channel allows for the endoscope to be used with or without the first guide (paragraph 0044) while in the channel.
Bunch is considered to be analogous to the claimed invention because it is in the same field of endoscopes with guiding systems for an accessory. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guide of Stefanchik ‘096, as modified by Stefanchik ‘758 and Peh, to incorporate the teachings of Bunch by adding the first guide to a tube within the channel. Doing so would allow the endoscope to be used with or without the first guide while in the channel, as recognized by Bunch.
Allowable Subject Matter
Claims 24 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 24, Stefanchik ‘096, as previously modified by Stefanchik ‘758, Peh, and Ghabrial, teaches the endoscope according to claims 15 and 23. However, Stefanchik ‘096, as modified by Stefanchik ‘758, Peh, and Ghabrial, fails to explicitly teach wherein the housing further includes a raising base.
Regarding claim 26, Stefanchik ‘096, as previously modified by Stefanchik ‘758, Peh, and Ghabrial, teaches the endoscope according to claims 1 and 25. However, Stefanchik ‘096, as modified by Stefanchik ‘758, Peh, and Ghabrial, fails to explicitly teach wherein the housing further includes a raising base.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modify the above endoscope to have the above features.
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 OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795