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 1, 4-7, 22-24, 26, 34-35, 37-39, 57, 59-60, 63, 65, 70, and 72-74 are pending, claims 2-3, 8-21, 25, 27-33, 36, 40-56, 58, 61-62, 64, 66-69, and 71 have been cancelled, and claims 72-74 have been added, claims 1, 4-7, 22-24, 26, 34-35, 37-39, 57, 59-60, 63, 65, 70, and 72-74 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-7, 22-24, 26, 34-39, 57, 59-60, 63, 65, and 70 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 22, 26, 64, and 72 are objected to because of the following informalities:
Regarding claim 22, on line 33, change “each of the the” to “each of the”.
Regarding claim 26, change “moulded” to “molded”.
Regarding claim 64, on line 7, change “the insertion tube;.” to “the insertion tube.”
Regarding claim 72, on line 2, change “insertion tube tube” to “insertion tube”.
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 video processing apparatus” in claims 39 and 70.
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 § 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 37-38, 57, 59-60, 63, 65, 70, and 72-74 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.
Regarding claim 37, the feature “the fluid discharge opening” lacks antecedent basis and has not been previously recited.
Regarding claim 38, the feature “the interstitial space” and “the fluid discharge opening” lack antecedent basis and have not been previously recited.
Regarding claim 57, the feature “the outlet end of the fluid passage” lacks antecedent basis and has not been previously recited. Dependent claims (or claims that refer back to claim 57) 59-60, 63, 65, 70, and 72-74 are rejected due to their dependency on claim 57.
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) 1, 26, 38-39, 57, 63, 65, 70, and 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819), in view of Matthison-Hansen (US 2020/0138268).
Regarding claim 1, Ouyang discloses an endoscope (see 100, figure 1) comprising: a handle housing (104, figure 5) comprising an internal space (see fluid inflow 618, figure 6; [0099]); an insertion cord (122, figure 4a) attached to the handle housing (see how the proximal end of 122 is attached to 104 and 108, figure 4a), the insertion cord including: an insertion tube (see the shaft 122, figure 4a) having an internal surface (see circular internal surface of 122, figure 9c), a distal end and a proximal end (see distal and proximal ends of 122, figure 4a); a distal tip (120, figure 4a), the distal tip comprising a camera (camera in tip 120 [0095]); electrical conductors extending from the camera to the handle (electrical cable…between the camera module…to connection pins housed within sleeve 460 [0093]; see figure 4b); a working channel tube (see 116 and 628, figure 6) extending through the insertion tube (822, figure 9c); a sealing body (see part of 470 with 618 in it, figure 8b) positioned in the internal space of the handle housing, the proximal end of the insertion tube being sealingly connected to (see arrows for 618, figure 8b), and sealed from the internal space of the handle housing by (see gasket 620, figure 8b), the sealing body (see figure 8b); and a fluid passage (see 618, figure 6) inside the handle and comprising an outlet end (114a, figure 6) sealingly connected to the sealing body, wherein the insertion tube comprises an interstitial lumen (614 and 616, figures 7 and 8b) formed at least between the internal surface, and the working channel tube (see how 618 enters into 614 and 616 of 122, figure 6 | the Examiner interpreted how the fluid 618 enters into 614 and 616, which is around 820 and 822 in figure 9c, to be an interstitial lumen that is between the internal surface and internal channels/lumens), said interstitial lumen directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the working channel tube, and the internal surface of the insertion tube (see 614 and 616 of 122, figures 6 and 9c). Ouyang is silent regarding a bending section connected to the distal end of the insertion tube: a distal tip extending distally from the bending section; the electrical conductors extending through the bending section and the insertion tube; the working channel tube extending through the insertion tube and the bending section; pull cable sheaths extending through the insertion tube: and pull cables extending through the pull cable sheaths; wherein the insertion tube comprises an interstitial lumen formed at least between the internal surface, the working channel tube, and the pull cable sheaths, said interstitial lumen directing a fluid discharged from the outlet end of the fluid passage through the insertion cord indirect fluid contact with the working channel tube, the pull cable sheaths and the internal surface of the insertion tube.
Matthison-Hansen teaches an endoscope (1, figure 1) with a control handle (2, figure 1) and an insertion cord (3, figure 1). The insertion cord has a distal end (4, figure 1) with a bending section (5, figures 1-2) and a distal tip (7, figure 2). A monitor (30, figure 1) may be connected to the handle through a cable (31, figure 1). The bending section is comprised of a number of sections including a distal end segment (11, figure 2) and a proximal end segment (13, figure 2), with a number of segments (12, figure 2) arranged between the two. The segments (11-13, figure 2) are interconnected connected by hinges (14, figure 2), where the hinges are integrally made from the same material as the segments ([0037]). Holes (15, figure 2) in the bending section are for positioning pull wires ([0039]). The pull wires are arranged inside guide tubes, thereby forming Bowden cables from the handle to the proximal segment of the bending section ([0039]). The guide tubes terminate at the proximal segment (13, figure 2) and the pull wires continues through the holes in the bending section ([0039]). A bending cover is provided to protect the bending section ([0036]).
It would have been obvious to one of ordinary skill in the art to modify the endoscope of Ouyang to have the bending section (5, figure 2), bending cover ([0036]) and Bowden cables ([0039]) as taught by Matthison-Hansen. Doing so would provide a bending section that allow the maneuvering of the tip of the endoscope ([0005]). The modified endoscope would have a bending section (5, figure 2; Matthison-Hansen) connected to the distal end of the insertion tube (see 5 connected to 3, figure 2); the distal tip (120, figure 4a; Ouyang) extending distally from the bending section (see 7 extending distally from 5, figure 2; Matthison-Hansen); the electrical conductors extending through the bending section and the insertion tube (electrical cable…between the camera module…to connection pins housed within sleeve 460 [0093]; see figure 4b; Ouyang | see 7 connected to 5 that connects to 3; figure 1 of Matthison-Hansen); the working channel tube (see 116 and 628, figure 6; Ouyang) extending through the insertion tube and the bending section (see 5 connect to 3, figure 1; Matthison-Hansen); pull cable sheaths (guide tubes…from the control handle to the proximal segment 13 [0039]; see figures 1-2) extending through the insertion tube: and pull cables (pull wires arranged inside guide tubes [0039]) extending through the pull cable sheaths; wherein the insertion tube comprises the interstitial lumen (614 and 616, figures 7 and 8b; Ouyang) formed at least between the internal surface, the working channel tube, and the pull cable sheaths (see how 618 enters into 614 and 616 of 122, figure 6; Ouyang | the Examiner interpreted how the fluid 618 enters into 614 and 616, which is around 820 and 822 in figure 9c, to be an interstitial lumen that is between the internal surface and internal channels/lumens | guide tubes…of the bending section [0039]; Matthison-Hansen), said interstitial lumen directing the fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the working channel tube, the pull cable sheaths and the internal surface of the insertion tube (see 614 and 616 of 122, figures 6 and 9c; Ouyang | guide tubes…[0039]; Matthison-Hansen).
Regarding claim 26, Ouyang further discloses the sealing body is constituted by a single moulded body (molded…barrier 530…manufactured [0101]; Ouyang | interpreted the barrier 530 can be a single molded piece or two molded halves), and wherein the single moulded body is moulded in situ (manufactured [0101] | glue…between the barrier 530 and shell 470 [0102]).
Regarding claim 38, Ouyang further discloses the distal tip comprises a fluid channel (distal tip…channels for fluid in-flow [0109]; Ouyang) having a distal end and a proximal end in fluid communication with the interstitial space (in-flow fluid lumens 614 and 616 [0099]; Ouyang | interpreted 614 and 616 to be lumens that are created by space between the insertion tube and components), and wherein the distal end comprises the fluid discharge opening ([0109]).
Regarding claim 39, Ouyang discloses an endoscope system comprising: the endoscope of claim 1 (see rejection of claim 1 above); and a video processing apparatus (this element is interpreted under 35 USC 112f as a monitor | see 110, figure 1; Ouyang).
Regarding claim 57, Ouyang discloses an endoscope (see 100, figure 1) comprising: a handle (104, figure 5) including a handle housing (see 104, figure 5), an irrigation inlet port (114a, figure 8b) adapted to receive irrigation fluid (see 618, figure 8b), and an irrigation channel (see channel for 618, figure 8b); a working channel tube (see 116 and 628, figure 6); and an insertion cord (122, figure 4a) extending distally from the handle (see how the proximal end of 122 is attached to 104 and 108, figure 4a), the insertion cord including: an insertion tube (see the shaft 122, figure 4a) having an internal surface (see circular internal surface of 122, figure 9c), a distal end and a proximal end (see distal and proximal ends of 122, figure 4a); a distal tip (120, figure 4a) including a tip housing (see 120 and 1040, figure 10); a camera (camera in tip 120 [0095]) at least partially enclosed in the tip housing; interstitial space (614 and 616, figures 7 and 8b) within the insertion tube in fluid communication with the irrigation channel (see 618, figure 8b); and at least one interstitial flow opening (614 and 616, figure 10) in fluid communication with the interstitial space and adapted to discharge the irrigation fluid ([0103]), wherein the working channel tube extend through the insertion tube (822, figure 9c), and wherein the interstitial space is formed at least between the internal surface, the working channel tube (see how 618 enters into 614 and 616 of 122, figure 6 | the Examiner interpreted how the fluid 618 enters into 614 and 616, which is around 820 and 822 in figure 9c, to be the interstitial space that is between the internal surface and internal channels/lumens), said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the working channel tube, and the internal surface of the insertion tube (see 614 and 616 of 122, figures 6 and 9c). Ouyang is silent regarding pull cable sheaths; and pull cables extending through the pull cable sheaths; a bending section extending from the insertion tube, the bending section comprising a one-piece part comprising segments and hinges interconnecting the segments to each other, the segments including a distal segment; a bending section cover; the distal tip extending from the bending section; wherein the pull cable sheaths extend through the insertion tube; and wherein the interstitial space is formed at least between the internal surface, the working channel tube, and the pull cable sheaths; said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the pull cable sheaths.
Matthison-Hansen teaches an endoscope (1, figure 1) with a control handle (2, figure 1) and an insertion cord (3, figure 1). The insertion cord has a distal end (4, figure 1) with a bending section (5, figures 1-2) and a distal tip (7, figure 2). A monitor (30, figure 1) may be connected to the handle through a cable (31, figure 1). The bending section is comprised of a number of sections including a distal end segment (11, figure 2) and a proximal end segment (13, figure 2), with a number of segments (12, figure 2) arranged between the two. The segments (11-13, figure 2) are interconnected connected by hinges (14, figure 2), where the hinges are integrally made from the same material as the segments ([0037]). Holes (15, figure 2) in the bending section are for positioning pull wires ([0039]). The pull wires are arranged inside guide tubes, thereby forming Bowden cables from the handle to the proximal segment of the bending section ([0039]). The guide tubes terminate at the proximal segment (13, figure 2) and the pull wires continues through the holes in the bending section ([0039]). A bending cover is provided to protect the bending section ([0036]).
It would have been obvious to one of ordinary skill in the art to modify the endoscope of Ouyang to have the bending section (5, figure 2) with the distal tip (7, figure 2), bending cover ([0036]) and Bowden cables ([0039]) as taught by Matthison-Hansen. Doing so would provide a bending section that allow the maneuvering of the tip of the endoscope ([0005]). The modified endoscope would have pull cable sheaths (guide tubes…from the control handle to the proximal segment 13 [0039]; see figures 1-2; Mathison-Hansen); and pull cables (pull wires arranged inside guide tubes [0039]) extending through the pull cable sheaths; a bending section (5, figure 2) extending from the insertion tube (see 5 connected to 3, figure 2), the bending section comprising a one-piece part (integrally made…single continuous piece of material [0037]) comprising segments (12, figure 2) and hinges (14, figure 2) interconnecting the segments to each other, the segments including a distal segment (11, figure 2); a bending section cover (bending cover [0036]); the distal tip extending from the bending section (see 7 extending distally from 5, figure 2); wherein the pull cable sheaths extend through the insertion tube (guide tubes…from the control handle to the proximal segment 13 [0039]); and wherein the interstitial space is formed at least between the internal surface, the working channel tube, and the pull cable sheaths (see how 618 enters into 614 and 616 of 122, figure 6; Ouyang | the Examiner interpreted how the fluid 618 enters into 614 and 616, which is around 820 and 822 in figure 9c, to be an interstitial space that is between the internal surface and internal channels/lumens | guide tubes…of the bending section [0039]; Matthison-Hansen); said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the pull cable sheaths (see 614 and 616 of 122, figures 6 and 9c; Ouyang | guide tubes…[0039]; Matthison-Hansen).
Regarding claim 63, Ouyang and Matthison-Hansen further disclose the tip housing comprises a distal wall (see the distal end of 7, figure 2; Matthison-Hansen) and a circumferential wall (see the circumferential/side walls of 7, figure 2) extending proximally from the distal wall, and wherein the at least one interstitial flow opening comprises a passage in the circumferential wall or in the front wall (distal tip…channels for fluid in-flow [0109]; Ouyang).
Regarding claim 65, Ouyang further discloses a fluid joint body (see inside of shell 470, figure 8b; Ouyang | glue…bonded [0101] see barrier 530 figure 7) inside the handle housing, the fluid joint body including: an irrigation passage (part of 104 that connects to 114a, figure 8b) to sealingly and fluidly connect an internal space of the fluid joint body with the irrigation fluid channel (see 114a and the part of 104 next to 114a, figure 6); and an insertion tube passage (see 712, figure 7) to sealingly receive the insertion tube and thereby establish fluid communication between the internal space and the interstitial space of the insertion tube (see figure 8b; [0101]).
Regarding claim 70, Ouyang discloses a visualization system comprising: the endoscope of claim 57 (see rejection of claim 57 above); and a video processing apparatus (this element is interpreted under 35 USC 112f as a monitor | see 110, figure 1; Ouyang) operable to receive live images from the endoscope.
Regarding claim 73, Ouyang further discloses the handle housing comprises internal walls (see wall next to 620, figure 8a; Ouyang), and wherein the irrigation passage is formed by and between the internal walls (see 618, figure 8b).
Regarding claim 74, Ouyang further discloses the handle housing comprises interlocking internal walls (see 470a-b, figure 8a; Ouyang), and wherein the irrigation passage is formed by and between the interlocking internal walls (see 618, figure 8b).
Claim(s) 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819) and Matthison-Hansen (US 2020/0138268) as applied to claim 1 above, and further in view of Heimberger (US 2022/0000350).
Regarding claim 4, Matthison-Hansen further teaches the insertion cord further comprises an outer tubular sheath (bending cover [0036]; Matthison-Hansen) covering the bending section (bending cover [0036]), wherein the bending section includes an interstitial space (see the lumen in bending section 5, such as the working channel passage 10, figure 2; [0036]) and a fluid opening (see openings of the hinges 14, figure 2), the interstitial space being in fluid communication with the interstitial lumen to receive the fluid (the modified endoscope would connect the interstitial space and 614 and 616, figure 6 of Ouyang). Ouyang and Matthison-Hansen are silent regarding a fluid discharge opening, and wherein the fluid opening is in fluid communication with the fluid discharge opening to discharge the fluid therethrough.
Heimberger teaches a bendable shank section (4, 49, figures 7). A distal shank end (17, 51, 139, figures 7) comprises a connection sleeve (197, figures 7), by way of which the distal end sleeve (195, figures 7) is positively fastened to a shaft (3, figure 7a). The end sleeve (195, figures 7) has a recess and the connection sleeve (197, figures 7) an indentation (201, figures 7) which is shaped in a manner which correspondingly matches the recess ([0101]). The connection sleeve (197, figures 7) in an overlapping section overlaps the distal end of the slotted bendable shank section (9, 49, figures 7). Lateral rinsing openings (203, figures 7) are present in the overlapping section, with the slots (33, 55, 64, figure 7c) surrounded by a protective flexible tube, the rinsing openings serve as a distal rinsing outlet or rinsing inlet of the fluid channel ([0102]).
It would have been obvious to one of ordinary skill in the art to modify the endoscope with the connection sleeve (197, figures 7), distal end sleeve (195, figures 7), and lateral rinsing openings (203, figure 7) as taught by Heimberger. Doing so would provide a rinsing outlet of a fluid channel ([0102]). The modified endoscope would have a fluid discharge opening (203, figures 7; Heimberger | or distal tip…channels for fluid in-flow [0109]; Ouyang), and wherein the fluid opening is in fluid communication with the fluid discharge opening to discharge the fluid therethrough (lateral rinsing openings…slots…surrounded by a flexible tube…serve as a distal rinsing outlet [0102]; Heimberger).
Regarding claim 5, Ouyang and Matthison-Hansen and Heimberger further disclose the bending section comprises segments (see 11-13, figure 2; Matthison-Hansen) including a distal segment (11, figure 2), a proximal segment (13, figure 2), and intermediate segments (12, figure 2) between the distal segment and the proximal segment, and wherein the fluid opening is positioned between any two of the segments or in one of the segments (the modified endoscope would connect the interstitial space and 614 and 616, figure 6 of Ouyang | lateral rinsing openings…slots…surrounded by a flexible tube…serve as a distal rinsing outlet [0102]; Heimberger).
Regarding claim 6, Heimberger further teaches the fluid discharge opening comprises an opening in the outer tubular sheath (203, figures 7; Heimberger) or an opening between the outer tubular sheath and an exterior surface of one of the segments.
Regarding claim 7, Ouyang further discloses the distal tip comprises a fluid channel (distal tip…channels for fluid in-flow [0109]; Ouyang) having a proximal end in fluid communication with the interstitial space and a distal end (in-flow fluid lumens 614 and 616 [0099]; Ouyang | interpreted 614 and 616 to be lumens that are created by space between the insertion tube and components, like the wire/wire pipe and electrical components, within it), the distal end comprising the fluid discharge opening ([0109]).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819) and Matthison-Hansen (US 2020/0138268) as applied to claim 1 above, and further in view of Osaki (US 2016/0213227).
Regarding claim 22, Ouyang and Matthison-Hansen disclose all of the features in the current invention as shown above in claim 1. They are silent regarding a pipe sealing extending around each of the the pull cable sheaths.
Osaki teaches the use of an adhesive to provide resistance against cleaning solution, disinfecting liquid, and the like ([0145]). The adhesive improves durability ([0145]).
It would have been obvious to modify the endoscope to use an adhesive around the pull cable sheaths as taught by Osaki ([0145]). Doing so would improve the wire pipe’s durability ([0145]). The modified endoscope would have a pipe sealing extending around each of the the pull cable sheaths (adhesive [0145]; Osaki).
Claim(s) 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819) and Matthison-Hansen (US 2020/0138268) and Osaki (US 2016/0213227) as applied to claim 22 above, and further in view of Kondoh (US 2010/0217072).
Regarding claim 23, Osaki further teaches a sealing glue in the pull cable sheaths (adhesive [0145]; Osaki). They are silent regarding a slip means between the sealing glue and the pull cables.
Kondoh teaches using a silicon oil may be used for a wire to reduce friction with a coiled tube or an insertion pipe ([0247]).
It would have been obvious to modify the endoscope to use silicon oil as taught by Kondoh ([0247]). Doing so would reduce friction with wire pipe ([0247]). The modified endoscope would have a slip means (this element is interpreted under 35 USC 112f as oil | silicon oil [0247]; Kondoh) between the sealing glue and the pull cables (wire…friction with the coiled tube [0247]).
Regarding claim 24, Osaki further teaches the pipe sealing is constituted by the sealing glue (adhesive [0145]; Osaki).
Claim(s) 37 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819) and Matthison-Hansen (US 2020/0138268) as applied to claims 1 and 57 above, and further in view of Taylor (US 2019/0105078).
Regarding claim 37, Matthison-Hansen further teaches the insertion cord further comprises an outer tubular sheath covering the bending section ([0036]; Matthison-Hansen). They are silent regarding wherein the fluid discharge opening is closed in a relaxed condition of the outer tubular sheath and opens when the outer tubular sheath is subject to a pressure of the fluid introduced through the proximal end of the insertion cord.
Taylor teaches a micro-seal (11, figure 5) that act as a zero seal ([0030]), which is normally closed. Under pressure from insufflation gas, the micro-seal would open to enable the flow of the insufflation gas into the body cavity ([0045]).
It would have been obvious to modify the fluid discharge opening with a micro-seal (11, figure 5) as taught by Taylor. Doing so would provide a zero seal ([0030]) and open when under pressure ([0045]). The modified endoscope would have wherein the fluid discharge opening is closed in a relaxed condition of the outer tubular sheath (zero seal [0030]; Taylor) and opens when the outer tubular sheath is subject to a pressure of the fluid introduced through the proximal end of the insertion cord (under pressure…would open [0045]).
Regarding claim 59, Ouyang and Matthison-Hansen disclose all of the features in the current invention as shown above in claim 57. They are silent regarding the at least one interstitial flow opening comprises a pressure-dependent slit in the bending section cover.
Taylor teaches a micro-seal (11, figure 5) that act as a zero seal ([0030]), which is normally closed. Under pressure from insufflation gas, the micro-seal would open to enable the flow of the insufflation gas into the body cavity ([0045]). The micro-seal can be a single slit, a plurality of slits, a double duckbill valve with slits ([0044]).
It would have been obvious to modify the fluid discharge opening with a micro-seal (11, figure 5) as taught by Taylor. Doing so would provide a zero seal ([0030]) and open when under pressure ([0045]). The modified endoscope would have the at least one interstitial flow opening comprises a pressure-dependent slit (slit; [0044]; under pressure…micro-seal…would open [0045]; Taylor) in the bending section cover.
Claim(s) 72 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 2016/0174819) and Matthison-Hansen (US 2020/0138268) as applied to claim 57 above, and further in view of Reever (US 2018/0132703).
Regarding claim 72, Ouyang further discloses a fluid joint body (see inside of shell 470, figure 8b; Ouyang | glue…bonded [0101] see barrier 530 figure 7a) inside the handle housing. Ouyang and Matthison-Hansen are silent regarding wherein a portion of the fluid joint body is positioned in the insertion tube tube and comprises: an irrigation passage to sealingly and fluidly connect the irrigation channel with the interstitial space; pull cable passages; and a working channel passage.
Reever teaches an insertion device (10, figure 1) with a hollow handle (12, figure 1). The handle has ports (22 and 24, figure 3) connected to tubes (44, figure 3) for fluidly coupling to a source of irrigation fluid, a source of aspiration fluid, a source of medicament for infusion, etc. ([0034]). The tubes (44, figure 3) extend through the shaft ([0034]).
It would have been obvious to modify the endoscope, specifically the fluid joint body, to have a tube (44, figure 3) that connects the irrigation channel to the interstitial space as taught by Reever (figure 3; [0034]). Doing so would provide a tube to connect the interstitial space with a source of irrigation fluid ([0034]). The modified endoscope would have wherein a portion of the fluid joint body is positioned in the insertion tube tube (see 44, figure 3; Reever | the modified endoscope would have a tube that connects the interstitial space with the irrigation channel/port) and comprises: an irrigation passage (see 44, figure 3; Reever) to sealingly and fluidly connect the irrigation channel with the interstitial space; pull cable passages (guide tubes…from the control handle to the proximal segment 13 [0039]; see figures 1-2; Matthison-Hansen); and a working channel passage (see 116 and 628, figure 6; Ouyang).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 4-7, 34, 38-39, 57, and 59-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, 12, 15, and 17 of U.S. Patent No. Ghani (US 12,575,721) in view of Matthison-Hansen (US 2020/0138268).
Regarding claim 1, Ghani discloses an endoscope (claim 1) comprising: a handle housing (claim 1) comprising an internal space; an insertion cord attached to the handle housing (claim 1), the insertion cord including: an insertion tube having an internal surface (claim 1), a distal end and a proximal end (insertion tube; claim 1); a bending section connected to the distal end of the insertion tube (claim 1); a distal tip extending distally from the bending section (claim 1), the distal tip comprising a camera (claim 1); electrical conductors extending from the camera to the handle through the bending section and the insertion tube (claim 8): a working channel tube extending through the insertion tube and the bending section (claims 7-8); pull cables (claim 1); a sealing body (fluid joint body; claim 6) positioned in the internal space of the handle housing, the proximal end of the insertion tube being sealingly connected to, and sealed from the internal space of the handle housing by, the sealing body (an insertion tube passage to sealingly receive…; claim 6); and a fluid passage (irrigation channel; claim 1 | irrigation passage; claim 6) inside the handle and comprising an outlet end sealingly connected to the sealing body (irrigation inlet port; claim 1), wherein the insertion tube comprises an interstitial lumen formed at least between the internal surface, and the working channel tube (interstitial space; claim 1), said interstitial lumen directing a fluid discharged from the outlet end of the fluid passage through the insertion cord indirect fluid contact with the working channel tube, and the internal surface of the insertion tube (interstitial flow opening; claim 1). Ghani is silent regarding pull cable sheaths extending through the insertion tube: and the pull cables extending through the pull cable sheaths; wherein the insertion tube comprises an interstitial lumen formed at least between the internal surface, the working channel tube, and the pull cable sheaths, said interstitial lumen directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the working channel tube, the pull cable sheaths and the internal surface of the insertion tube.
Matthison-Hansen teaches an endoscope (1, figure 1) with a control handle (2, figure 1) and an insertion cord (3, figure 1). The insertion cord has a distal end (4, figure 1) with a bending section (5, figures 1-2) and a distal tip (7, figure 2). A monitor (30, figure 1) may be connected to the handle through a cable (31, figure 1). The bending section is comprised of a number of sections including a distal end segment (11, figure 2) and a proximal end segment (13, figure 2), with a number of segments (12, figure 2) arranged between the two. The segments (11-13, figure 2) are interconnected connected by hinges (14, figure 2), where the hinges are integrally made from the same material as the segments ([0037]). Holes (15, figure 2) in the bending section are for positioning pull wires ([0039]). The pull wires are arranged inside guide tubes, thereby forming Bowden cables from the handle to the proximal segment of the bending section ([0039]). The guide tubes terminate at the proximal segment (13, figure 2) and the pull wires continues through the holes in the bending section ([0039]). A bending cover is provided to protect the bending section ([0036]).
It would have been obvious to one of ordinary skill in the art to modify the endoscope of Ouyang to have the bending section (5, figure 2), bending cover ([0036]) and Bowden cables ([0039]) as taught by Matthison-Hansen. Doing so would provide a bending section that allow the maneuvering of the tip of the endoscope ([0005]). The modified endoscope would have pull cable sheaths (guide tubes…from the control handle to the proximal segment 13 [0039]; see figures 1-2; Matthison-Hansen) extending through the insertion tube: and the pull cables extending through the pull cable sheaths (pull wires arranged inside guide tubes [0039]); wherein the insertion tube comprises an interstitial lumen (interstitial space; claim 1; Ghani) formed at least between the internal surface, the working channel tube, and the pull cable sheaths (guide tubes [0039]), said interstitial lumen directing the fluid discharged from the outlet end of the fluid passage through the insertion cord (interstitial flow opening; claim 1; Ghani) in direct fluid contact with the working channel tube, the pull cable sheaths (guide tubes [0039]; Matthison-Hansen) and the internal surface of the insertion tube.
Regarding claim 4, Ghani further discloses the insertion cord further comprises an outer tubular sheath covering the bending section (bending section cover; claim 1), and a fluid discharge opening (interstitial flow opening; claim 1), wherein the bending section includes an interstitial space (interstitial space…interstitial flow opening; claim 1) and a fluid opening (interstitial flow opening; claim 1), the interstitial space being in fluid communication with the interstitial lumen to receive the fluid (interstitial space; claim 1), and wherein the fluid opening is in fluid communication with the fluid discharge opening to discharge the fluid therethrough (interstitial flow opening…a gap…; claim 1).
Regarding claim 5, Ghani further discloses the bending section comprises segments including a distal segment (segments…distal segment; claim 1), a proximal segment (segments; claim 1), and intermediate segments (segments; claim 1) between the distal segment and the proximal segment, and wherein the fluid opening is positioned between any two of the segments or in one of the segments (distal segments…interstitial flow opening; claim 1).
Regarding claim 6, Ghani further discloses the fluid discharge opening comprises an opening in the outer tubular sheath or an opening between the outer tubular sheath and an exterior surface of one of the segments (gap…; claim 1).
Regarding claim 7, Ghani further discloses the distal tip comprises a fluid channel having a proximal end in fluid communication with the interstitial space and a distal end (tip housing…interstitial flow opening…gap; claim 1), the distal end comprising the fluid discharge opening (interstitial flow opening…; claim 1).
Regarding claim 34, Ghani further discloses the insertion cord further comprises an outer tubular sheath covering the bending section (bending section cover; claim 1), a distal segment (distal segment; claim 1), and a fluid discharge opening (interstitial flow opening; claim 1), wherein the distal tip comprises a tip housing (tip housing; claim 1); wherein the outer tubular sheath overlaps, and is bonded to, the distal segment and/or the tip housing (claim 1), at circumferentially spaced bonding sites with unbonded portions of the outer tubular sheath disposed between the bonding sites (claim 1), and wherein the fluid discharge opening comprises a gap between an unbonded and unperforated portion of the outer tubular sheath and the distal segment and/or the tip housing (claim 1).
Regarding claim 38, Ghani further discloses the distal tip comprises a fluid channel having a distal end and a proximal end in fluid communication with the interstitial space (interstitial space…interstitial flow opening….the distal segment and/or the tip housing; claim 1), and wherein the distal end comprises the fluid discharge opening (interstitial flow opening; claim 1).
Regarding claim 39, Ghani discloses an endoscope system comprising: the endoscope of claim 1 (claim 12); and a video processing apparatus (claim 12).
Regarding claim 57, Ghani discloses an endoscope (claim 15) comprising: a handle (claim 15) including a handle housing (claim 15), an irrigation inlet port adapted to receive irrigation fluid (irrigation inlet port; claim 15), and an irrigation channel (claim 15); and pull cables (claim 15); and an insertion cord extending distally from the handle (claim 15), the insertion cord including: an insertion tube having an internal surface (claim 15), a distal end and a proximal end (insertion tube; claim 15); a bending section extending from the insertion tube (claim 15), the bending section comprising segments and hinges (hinged segments; claim 15) interconnecting the segments to each other, the segments including a distal segment (distal segment; claim 15); a bending section cover (claim 15); a distal tip extending from the bending section and including a tip housing (claim 15); a camera at least partially enclosed in the tip housing (claim 15); interstitial space within the insertion tube in fluid communication with the irrigation channel (claim 15); and at least one interstitial flow opening in fluid communication with the interstitial space and adapted to discharge the irrigation fluid (claim 15), said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact with the working channel tube, and the internal surface of the insertion tube (interstitial flow opening; claim 15). Ghani is silent regarding a working channel tube; pull cable sheaths; and the pull cables extending through the pull cable sheaths; the bending section comprising a one-piece part comprising segments and hinges interconnecting the segments to each other, wherein the pull cable sheaths extend through the insertion tube; wherein the working channel tube extend through the insertion tube, and wherein the interstitial space is formed at least between the internal surface, the working channel tube, and the pull cable sheaths, said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord in direct fluid contact the pull cable sheaths.
Matthison-Hansen teaches an endoscope (1, figure 1) with a control handle (2, figure 1) and an insertion cord (3, figure 1). The insertion cord has a distal end (4, figure 1) with a bending section (5, figures 1-2) and a distal tip (7, figure 2). A monitor (30, figure 1) may be connected to the handle through a cable (31, figure 1). The bending section is comprised of a number of sections including a distal end segment (11, figure 2) and a proximal end segment (13, figure 2), with a number of segments (12, figure 2) arranged between the two. The segments (11-13, figure 2) are interconnected connected by hinges (14, figure 2), where the hinges are integrally made from the same material as the segments ([0037]). Holes (15, figure 2) in the bending section are for positioning pull wires ([0039]). The pull wires are arranged inside guide tubes, thereby forming Bowden cables from the handle to the proximal segment of the bending section ([0039]). The guide tubes terminate at the proximal segment (13, figure 2) and the pull wires continues through the holes in the bending section ([0039]). A bending cover is provided to protect the bending section ([0036]). Further, a working channel (10, figure 2) continues all the way through the bending section ([0038]).
It would have been obvious to one of ordinary skill in the art to modify the endoscope of Ouyang to have the bending section (5, figure 2), bending cover ([0036]), a working channel (10, figure 2), and Bowden cables ([0039]) as taught by Matthison-Hansen. Doing so would provide a bending section that allow the maneuvering of the tip of the endoscope ([0005]) and the introduction of a tool ([0036]). The modified endoscope would have a working channel tube (10, figure 3; Matthison-Hansen); pull cable sheaths (guide tubes…from the control handle to the proximal segment 13 [0039]; see figures 1-2; Matthison-Hansen); and the pull cables extending through the pull cable sheaths (pull wires arranged inside guide tubes [0039]); the bending section comprising a one-piece part (integrally made…single continuous piece of material [0037]) comprising segments (12, figure 2) and hinges (14, figure 2) interconnecting the segments to each other, wherein the pull cable sheaths extend through the insertion tube (guide tubes…from the control handle to the proximal segment 13 [0039]); wherein the working channel tube extend through the insertion tube (working channel [0038]), and wherein the interstitial space (interstitial space; claim 15; Ghani) is formed at least between the internal surface, the working channel tube (10, figure 3; Matthison-Hansen), and the pull cable sheaths (guide tubes [0039]), said interstitial space directing a fluid discharged from the outlet end of the fluid passage through the insertion cord (interstitial flow opening; claim 15; Ghani) in direct fluid contact the pull cable sheaths (guide tubes [0039]; Matthison-Hansen).
Regarding claim 59, Ghani further discloses the at least one interstitial flow opening comprises a pressure-dependent slit in the bending section cover (slit…pressure-dependent; claim 15).
Regarding claim 60, Ghani further discloses the bending section cover overlaps the distal segment (claim 17) and is bonded to the distal segment or the tip housing at circumferentially spaced bonding sites with unbonded portions of the bending section cover disposed between the bonding sites (claim 17), wherein the at least one interstitial flow opening comprises a gap between an unbonded portion of the bending section cover and the distal segment or the tip housing (claims 15 and 17), and wherein the gap is closed when relaxed and open responsive to fluid pressure (claim 15).
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. Ghani (US 12,575,721) and Matthison-Hansen (US 2020/0138268) as applied to claim 34 above, and further in view of Taylor (US 2019/0105078).
Regarding claim 35, Ghani and Matthison-Hansen disclose all of the features in the current invention as shown above in claim 34. They are silent regarding the fluid discharge opening is a pressure-dependent interstitial fluid opening which is closed when relaxed and open responsive to fluid pressure.
Taylor teaches a micro-seal (11, figure 5) that act as a zero seal ([0030]), which is normally closed. Under pressure from insufflation gas, the micro-seal would open to enable the flow of the insufflation gas into the body cavity ([0045]). The micro-seal can be a single slit, a plurality of slits, a double duckbill valve with slits ([0044]).
It would have been obvious to modify the fluid discharge opening with a micro-seal (11, figure 5) as taught by Taylor. Doing so would provide a zero seal ([0030]) and open when under pressure ([0045]). The modified endoscope would have the fluid discharge opening (claim 1; Ghani) is a pressure-dependent interstitial fluid opening (zero seal [0030]; Taylor) which is closed when relaxed (normally closed; [0030]; Taylor) and open responsive to fluid pressure (under pressure…would open [0045]).
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
June 9, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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