DETAILED ACTION
The present Office action is in response to the amendments filed on 2 JUNE 2026.
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
Claims 1-3, 9, 16, 17, and 20 have been amended. Claims 6-8 have been cancelled. Claims 21-23 have been added. Claims 1-5 and 9-23 are pending and herein examined.
Response to Arguments
Applicant’s arguments, see Remarks, filed 2 JUNE 2026, with respect to the rejection(s) of each claim under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of U.S. Publication No. 2021/0068642 A1 (“Sørensen”) and U.S Publication No. 2021/0364778 A1 (hereinafter “Loo”). The arguments presented by Applicant are directed primary towards the U.S. Publication No. 2014/0210976 A1 reference, which is no longer relied upon. Instead, Loo is relied upon to show structural features, such as the bent configurations. See Loo, FIG. 4, flexible circuit board 110 with segments 111-114 and 116.
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, 3, 9-19, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0068642 A1 (hereinafter “Sørensen”) in view of U.S. Publication No. 2021/0364778 A1 (hereinafter “Loo”).
Regarding claim 1, Sørensen discloses a flexible circuit assembly ([0131], “flexible circuit”) for a medical device (FIG. 1, endoscope 1), the circuit assembly comprising:
a circuit board ([0131], “flexible circuit board”) having:
at least one flat portion (FIGS. 3, 4e, 4f, and 7b disclose flexible board circuit 70 as flat, and FIGS 6a and 6b, flexible board circuit 70’);
(FIG. 6a, first portion 70g extending distally. [0158], “A first portion 70g, a second portion 70h, and a third portion 70i of the FPC 70′ establish an electrical connection with the LEDs 9”); and
a mounting portion ([0158], “The third portions 70i may be electrically connected to the LED 9 by anisotropic conductive film (ACF) bonding”) having a second bending portion (FIG. 6a, between 70h and 70i there is a fold), wherein the central portion is configured to receive a camera or a lighting element (FIG. 6a, LED 9 connected to third portion 70i. [0158], “he third portions 70i comprise electrical connections to power the LEDs”), wherein, in an unbent configuration of the circuit board a distalmost end of the arm is distal to a distalmost end of the central portion (FIG. 6a, first portion 70g is distalmost to the third portion 70i connected to the LED); and
a mechanical support structure coupled to the circuit board in a bent configuration of the circuit board (FIG. 6b, LED holder 90 supporting the third portion 70i in a folded configuration), the mechanical support structure including:
a first region (FIG. 6b, LED holder 90 with interconnection portion 90c, the part of the LED holder situated distally from the third portion 70i), and
a second region extending distally from the first region (FIG. 6b, LED holder 90 with first and second portions 90a and 90b which connect to the third portion 70, and they extend from the interconnecting portion 90c that is part of the LED holder situated distally from the third portion 70i),
wherein the first bending portion is coupled to the second region of the mechanical support structure in the bent configuration of the circuit board (FIG. 6b, illustrates the LED holder 90 coupled to the camera assembly, which includes the first bending portion in the folded configuration).
Sørensen fails to expressly disclose an arm having a first bending portion,. Note, FIG. 6a of Sørensen’s disclosure depicts first portion 70g may possibly be bending downwards, at the beginning of the arm; however, for clarification purposes, a secondary reference will be relied upon.
However, Loo teaches an arm having a first bending portion, wherein the arm extends distally from the at least one flat portion ([0035], “the flexible circuit board 110 includes a first segment 111, a second segment 112 bent to be connected to the first segment 111, a third segment 113 and a fourth segment 114 bent to be connected to two sides of the second segment 112, a fifth segment 115 (see FIG. 5) bent to be connected to the fourth segment 114 and a sixth segment 116 bent to be connected to the third segment 113, wherein the first segment 111 extends away from the distal end 18, and the second segment 112, the third segment 113 and the sixth segment 116 surround a part of the lens holder 125.” FIG. 4 depicts sixth segment 116 coupled to the light source 130 and having a bend between it and third segment 113, which has a bend between it and second segment 112).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have multiple bent portions, as taught by Loo (FIG. 4), in Sørensen’s invention. One would have been motivated to modify Sørensen’s invention, by incorporating Loo’s invention, to optimize the position of elements within an endoscope for good imaging quality (Loo: [0004]).
Regarding claim 3, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the first bending portion comprises a first layered construction and the at least one flat portion comprises a second layered construction ([0055], “FPCs may, throughout this specification, be a single- or double-sided flexible circuit or a rigid-flex circuit, and may comprise one or more layers of conductive material and two or more layers of insulating material.” Note, 70 and 70g-70i are all part of the FPC and therefore layered).
Regarding claim 9, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Loo discloses wherein the at least one flat portion defines a first plane, and wherein a flat portion of the arm defines a second plane parallel to and different from the first plane (FIG. 4, first segment 111 is parallel to third segment 113). The same motivation of claim 1 applies to claim 9.
Regarding claim 10, Sørensen and Loo disclose every limitation of claim 9, as outlined above. Additionally, Loo discloses wherein a distal portion of the arm defines a third plane, and wherein the third plane is perpendicular to each of the first plane and the second plane (FIG. 4, sixth segment 116 is perpendicular to both first segment 111 and third segment 113). The same motivation of claim 1 applies to claim 10.
Regarding claim 11, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the circuit board is coupled to the mechanical support structure with an adhesive ([0162], “LED holder 90 and camera module support 82, and the entire assembly is then positioned, from the proximal opening, in the housing 8, 8′, 8″ before filling in the adhesive 80”).
Regarding claim 12, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the at least one flat portion of the circuit board is coupled to the first region of the mechanical support structure (FIG. 6b, LED holder 90 coupled to the camera assembly, which includes the entirety of the flexible circuit board).
Regarding claim 13, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the mechanical support structure comprises at least one of a polymeric material or a metal ([0153], “The LED holder 90 may be made from polymers selected to provide a rigid structure, such as crylonitrile butadiene styrene (ABS)”).
Regarding claim 14, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the mechanical support structure comprises at least one of a thermoplastic material or a thermoset material ([0153], “The LED holder 90 may be made from polymers selected to provide a rigid structure, such as crylonitrile butadiene styrene (ABS)”).
Regarding claim 15, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the flexible circuit assembly is configured to be incorporated into a distal assembly of an endoscope (FIG. 1a, endoscope 1 with tip part assembly 5 distal from the operating handle 2. FIG. 4e illustrates the tip part assembly with camera assembly 6, inclusive of the circuit board 70).
Regarding claim 16, Sørensen discloses a flexible circuit assembly ([0131], “flexible circuit”) for a medical device (FIG. 1, endoscope 1), comprising:
a circuit board ([0131], “flexible circuit board”) having;
a flat portion (FIGS. 3, 4e, 4f, and 7b disclose flexible board circuit 70 as flat, and FIGS 6a and 6b, flexible board circuit 70’);
at least one arm extending distally from the flat portion of the circuit board (FIG. 6a, first portion 70g extending distally. [0158], “A first portion 70g, a second portion 70h, and a third portion 70i of the FPC 70′ establish an electrical connection with the LEDs 9”)
a mounting portion ([0158], “The third portions 70i may be electrically connected to the LED 9 by anisotropic conductive film (ACF) bonding”) configured to receive a camera or a lighting element (FIG. 6a, LED 9 connected to third portion 70i. [0158], “he third portions 70i comprise electrical connections to power the LEDs”), wherein the mounting portion includes a second bending portion (FIG. 6a, between 70h and 70i there is a fold)
a mechanical support structure coupled to the circuit board (FIG. 6b, LED holder 90 supporting the third portion 70i in a folded configuration), the mechanical support structure having at least one arm extending distally from a first portion of the mechanical support structure (FIG. 6b, LED holder 90 includes first and second portions 90a and 90b, respectively, extending from interconnecting portion 90c),
wherein the at least one arm of the mechanical support structure is configured to be coupled to the at least one arm of the circuit board (FIG. 6b, LED holder 90 includes two arms that connect to the two circuit board arms 70g-70i extending at either side of the camera assembly).
Sørensen fails to expressly disclose wherein the at least one arm includes a first bending portion; and
wherein the first bending portion and the second bending portion are bent in the same direction in an assembly configuration of the flexible circuit assembly.
However, Loo teaches wherein the at least one arm includes a first bending portion ([0035], “the flexible circuit board 110 includes a first segment 111, a second segment 112 bent to be connected to the first segment 111, a third segment 113 and a fourth segment 114 bent to be connected to two sides of the second segment 112, a fifth segment 115 (see FIG. 5) bent to be connected to the fourth segment 114 and a sixth segment 116 bent to be connected to the third segment 113, wherein the first segment 111 extends away from the distal end 18, and the second segment 112, the third segment 113 and the sixth segment 116 surround a part of the lens holder 125.” FIG. 4 depicts sixth segment 116 coupled to the light source 130 and having a bend between it and third segment 113, which has a bend between it and second segment 112); and
wherein the first bending portion and the second bending portion are bent in the same direction in an assembly configuration of the flexible circuit assembly (FIG. 4, the bend between second segment 112 and third segment 113 is the same direction as the bend between the third segment 113 and sixth segment 116).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have multiple bent portions, as taught by Loo (FIG. 4), in Sørensen’s invention. One would have been motivated to modify Sørensen’s invention, by incorporating Loo’s invention, to optimize the position of elements within an endoscope for good imaging quality (Loo: [0004]).
Regarding claim 17, Sørensen and Loo disclose every limitation of claim 16, as outlined above. Additionally, Sørensen discloses wherein the first bending portion comprises a first layered construction and the flat portion comprises a second layered construction ([0055], “FPCs may, throughout this specification, be a single- or double-sided flexible circuit or a rigid-flex circuit, and may comprise one or more layers of conductive material and two or more layers of insulating material.” Note, 70 and 70g-70i are all part of the FPC and therefore layered).
Regarding claim 18, Sørensen and Loo disclose every limitation of claim 17, as outlined above. Additionally, Sørensen discloses wherein the first layered construction includes an adhesive layer, a conductive layer, and at least one flexible layer ([0055], “FPCs may, throughout this specification, be a single- or double-sided flexible circuit or a rigid-flex circuit, and may comprise one or more layers of conductive material and two or more layers of insulating material, and/or may be a flexible flat cable having one or more conductors”).
Regarding claim 19, Sørensen and Loo disclose every limitation of claim 17, as outlined above. Additionally, Sørensen discloses wherein the second layered construction includes an adhesive layer, a conductive layer, at least one flexible layer, and at least one dielectric layer ([0055], “FPCs may, throughout this specification, be a single- or double-sided flexible circuit or a rigid-flex circuit, and may comprise one or more layers of conductive material and two or more layers of insulating material, and/or may be a flexible flat cable having one or more conductors”).
Regarding claim 21, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Loo discloses wherein the first bending portion and the second bending portion are bent in the same direction in the bent configuration of the circuit board (FIG. 4, the bend between second segment 112 and third segment 113 is the same direction as the bend between the third segment 113 and sixth segment 116). The same motivation of claim 1 applies to claim 21.
Regarding claim 22, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses wherein the circuit board extends along only (a) a first side of the mechanical support structure and (b) distal surfaces of the mechanical support structure (FIG. 6b, the flexible circuit board portions 70 are all on the opposite side of the interconnecting portion 90c, the interconnecting portion 90c being a distal surface of the LED holder 90).
Regarding claim 23, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Loo discloses wherein the arm includes a third bending portion, and wherein the arm is bent at the first bending portion and the third bending portion in the bent configuration of the circuit board (FIG. 4 depicts at least three bending portions bent in the bent configuration of circuit board 110). The same motivation of claim 1 applies to claim 13.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0068642 A1 (hereinafter “Sørensen”) in view of U.S. Publication No. 2021/0364778 A1 (hereinafter “Loo”), and further in view of U.S. Publication No. 2020/0359879 A1 (hereinafter “Cahill”).
Regarding claim 2, Sørensen and Loo disclose every limitation of claim 1, as outlined above. Additionally, Sørensen discloses ([0125], “ The operating handle 2 has a control lever 21 for manoeuvring a tip part assembly 5 at a distal end 3b of the insertion tube 3 by means of a steering wire and bending section 4”).
Sørensen and Loo fail to expressly disclose wherein the first region comprises at least one extension, and wherein the at least one extension is configured to receive an articulation wire of the medical device.
However, Cahill teaches wherein the first region comprises at least one extension, and wherein the at least one extension is configured to receive an articulation wire of the medical device ([0028], “The distal assembly 152 comprises an articulation joint 210, distal cap 220, a plurality of cables and wires 245, e.g., for connections to a camera and LEDs, a Bowden disk 230, and two articulation wires 240(1) and 240(2). The cables and wires 245 within distal assembly 152 extend through shaft 150 and umbilicus 124 to a circuit board 250. Circuit board 250 may be at an end of umbilicus 124 that connects to the external controller.” [0032], “The distal cap 220 has four lumens, shown at reference numerals 221(1)-221(4) in FIG. 3B. The camera 222 and LEDs 224(a) and 224(b) may reside in a first lumen (e.g., lumen 221(1)), the articulation wire 240(1) may reside in a second lumen (e.g., lumen 221(2)), the articulation wire 240(2) may reside in a third lumen (e.g., lumen 221(3))”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have extension receive an articulation wire, as taught by Cahill ([0028]), in Sørensen and Loo’s invention. One would have been motivated to modify Sørensen’s invention, by incorporating Cahill and Loo’s invention, because it is an obvious combination of an articulation wire to a distal end of an endoscope according to known methods for creating the extension with an opening to yield predictable results. See MPEP § 2143(I)(A).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0068642 A1 (hereinafter “Sørensen”) in view of U.S. Publication No. 2021/0364778 A1 (hereinafter “Loo”), and further in view of U.S. Publication No. 2022/0030171 A1 (hereinafter “Haggerty”).
Regarding claim 4, Sørensen and Loo disclose every limitation of claim 3, as outlined above. Sørensen and Loo fail to expressly disclose wherein the first layered construction includes fewer layers than the second layered construction.
However, Haggerty teaches wherein the first layered construction includes fewer layers than the second layered construction (FIGS. 15, 33, and 53-54, circuit board 430. [0306], “each part of the projecting portion 430h may have differing levels of flexibility. Certain parts may be rigid circuit board, while other parts are flex cable. Additionally, each part of the circuit board may have different number of layers, different widths, different numbers of traces on each layer, etc.” [0305] and [0307] disclose a plurality of layers for the circuit board at different parts).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have different number of layers in a circuit board, as taught by Haggerty ([0306-0307]), in Sørensen and Loo’s invention. One would have been motivated to modify Sørensen and Loo’s invention, by incorporating Haggerty’s invention, to provide variable flexibility based on printed board coating or encasing for protection of components therein (Haggerty: [0305] and [0307]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0068642 A1 (hereinafter “Sørensen”) in view of U.S. Publication No. 2021/0364778 A1 (hereinafter “Loo”), and further in view of U.S. Publication No. 2015/0378144 A1 (hereinafter “Handte”).
Regarding claim 5, Sørensen and Loo disclose every limitation of claim 3, as outlined above. Sørensen and Loo fail to expressly disclose wherein the first layered construction is configured to achieve a bending radius less than 6 times a thickness of the second layered construction.
However, Handte teaches wherein the first layered construction is configured to achieve a bending radius less than 6 times a thickness of the second layered construction ([0012], “According to the invention, the subassembly comprises a preferably single-layer flex circuit board, which has a thickness between 40 μm and 100 μm, for example 60 μm. Such extremely thin circuit boards can be bent with particularly tight radii of curvature, and specifically also above 90° and more, so that quasi a folding of the circuit board is possible, by which means the constructional volume can be further reduced. According to the invention, one can bend such an extremely thin and flexible circuit board in a bending radius which corresponds to half to twice the thickness of the circuit board. The bending radius advantageously even corresponds to 0.8-fold to 1.2-fold the circuit board thickness, so that in the case of a circuit board thickness of 40 μm, one can also envisage an extremely small bending radius of 40 μm”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have bending radius based on the layered construction, as taught by Handte ([0012]), in Sørensen and Loo’s invention. One would have been motivated to modify Sørensen and Loo’s invention, by incorporating Handte’s invention, to have an inexpensive manufacture and an application in rigid as well as flexible endoscopes (Handte: [0012]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0068642 A1 (hereinafter “Sørensen”) in view of U.S. Publication No. 2020/0359879 A1 (hereinafter “Cahill”).
Regarding claim 20, Sørensen discloses a flexible circuit assembly ([0131], “flexible circuit”) for a medical device (FIG. 1, endoscope 1), comprising:
a circuit board ([0131], “flexible circuit board”) having a first portion (FIGS. 3, 4e, 4f, and 7b disclose flexible board circuit 70 as flat, and FIGS 6a and 6b, flexible board circuit 70’) and a second portion extending distally from the first portion (FIG. 6a, first portion 70g extending distally. [0158], “A first portion 70g, a second portion 70h, and a third portion 70i of the FPC 70′ establish an electrical connection with the LEDs 9”); and
a mechanical support structure coupled to the circuit board (FIG. 6b depicts a camera support module 82 coupled to the circuit board 70 along with the LED holder 90, which are further encapsulated by the housing 8” depicted in FIG. 4c), the mechanical support structure including:
a first region (FIG. 6a, camera support module 82), and
a second region extending distally from the first region (FIG. 6b, LED holder 90 surrounding camera support module 82);
([0125], “ The operating handle 2 has a control lever 21 for manoeuvring a tip part assembly 5 at a distal end 3b of the insertion tube 3 by means of a steering wire and bending section 4”).
Sørensen fails to expressly disclose wherein the first region comprises a first one extension projecting outwardly from a body of the first region, wherein the at least one extension includes an opening or a recess.
However, Cahill teaches wherein the first region comprises a first one extension projecting outwardly from a body of the first region, wherein the at least one extension includes an opening or a recess ([0028], “The distal assembly 152 comprises an articulation joint 210, distal cap 220, a plurality of cables and wires 245, e.g., for connections to a camera and LEDs, a Bowden disk 230, and two articulation wires 240(1) and 240(2). The cables and wires 245 within distal assembly 152 extend through shaft 150 and umbilicus 124 to a circuit board 250. Circuit board 250 may be at an end of umbilicus 124 that connects to the external controller.” [0032], “The distal cap 220 has four lumens, shown at reference numerals 221(1)-221(4) in FIG. 3B. The camera 222 and LEDs 224(a) and 224(b) may reside in a first lumen (e.g., lumen 221(1)), the articulation wire 240(1) may reside in a second lumen (e.g., lumen 221(2)), the articulation wire 240(2) may reside in a third lumen (e.g., lumen 221(3))”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have an articulation wire connection to an opening of a structural support component, as taught by Cahill ([0028]), in Sørensen’s invention. One would have been motivated to modify Sørensen’s invention, by incorporating Cahill’s invention, because it is an obvious combination of an articulation wire to a distal end of an endoscope according to known methods for creating the opening and recess to yield predictable results. See MPEP § 2143(I)(A).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Publication No. 2020/0196434 A1 (hereinafter “Kuo”) – Discloses a flexible printed circuit board used in an endoscope. FIG. 1 illustrates the circuit board in an unbent position and FIG. 8 illustrates the circuit board in the bent position.
U.S. Publication No. 2021/0186311 A1 (hereinafter “Levy”) – Discloses a foldable circuit board for a medical imaging device. FIG. 3A illustrates the foldable circuit board in an unfolded position and FIG. 3B illustrates the foldable circuit board in the folded position. FIG. 5 depicts a supporting cage 520 to support the foldable circuit board 510 in the folded position. See Levy, ¶ [0055].
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STUART D BENNETT/Examiner, Art Unit 2481