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 1-16, 19, and 21 are pending, claims 17-18 and 20 have been cancelled, claim 21 has been added, and claims 1-16, 19, and 21 are currently under consideration for patentability under 37 CFR 1.104.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16, 19, and 21 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 1, the limitation “the cured adhesive material extends parallelly to the FPC and to a distal end portion of the cannula” is unclear. It is unclear where the cured adhesive material extends from and to. Dependent claims 2-16, 19, and 21 are rejected due to their dependency on claim 1.
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) 1-13, 15-16, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fructus (US 2011/0184233), in view of Truckai (US 2018/0184892) and Bonneau (US 2016/0235478).
Regarding claim 1, Fructus discloses an endoscopic device, comprising: a housing (3, figure 1); a cannula (5, figure 1) configured to be inserted through a cervix into a uterus ([0003]), the cannula having a lumen (12, figure 1) that extends from a proximal end of the cannula to a distal end of the cannula and that is configured to allow passage of a working tool (13, figure 1 | appliance 13 [0036]), and the proximal end of the cannula being secured within the housing (see figure 1); an imaging system (10, figure 1) arranged at the distal end of the cannula, the imaging system comprising: a camera (image-forming system [0037]), and one or more light-emitting diodes (LEDs) (10sub2, figure 2) configured to provide light for the camera to acquire images of the uterus; a tip element (see distal portion of 7 and 8, figure 1) that holds the camera at the distal end of the cannula, wherein the tip element has a forward facing surface (see distalmost surface of 7-8, figure 2) and is configured to be moved through the cervix in a forward direction (insertion path [0004]), the forward facing surface having an opening (see opening for 10, figure 2) that exposes the camera at the distal end of the cannula; and a ramp-shaped guiding element (19, figure 2) positioned inside the cannula, having a first end located proximate the tip element (see distal end of 19, figure 2), and having a second end located farther away from the tip element (see proximal end of 19, figure 2), wherein the ramp-shaped guiding element at least in part defines or is positioned adjacent to a tool channel (12, figure 2) configured to allow passage of the working tool (13, figure 2), wherein the ramp-shaped guiding element has a thickness that changes between the first end and the second end (see 19, figure 2). Fructus is silent regarding the ramp-shaped guiding element is made of a cured adhesive material; a flexible printed circuit (FPC) that extends within the lumen of the cannula and electrically connects the camera and the one or more LEDs to electrical components located in the housing; and wherein a thickness difference between the first and second ends causes the ramp-shaped guiding element to guide the working tool away from electrical contacts of the camera to the FPC, wherein the ramp-shaped guiding element is formed onto a surface of the FPC such that the cured adhesive material extends parallelly to the FPC and to a distal end portion of the cannula.
Truckai teaches an endoscope system with an image sensor (120, figure 2) and LEDs (155, figure 2) at the distal end. Independent wires or an elongated flex circuit can extend through a passageway (160, figure 3) in the shaft (110, figure 1) and couple to the image processor ([0036]). Similarly, the LEDs can be connected to a remote electrical source and controller (140 figure 1; [0036]). The handle carries a detachable image display (122, figure 1). The image processor or components thereof can be carried in a handle (106, figure 1; [0031]). A controller/power source for the sensor and LEDs can be carried in the handle (“the component thereof can be carried in the handle” [0031]).
Bonneau teaches rigidity features of a proximal tapered portion (36, figures 2) of a balloon (24, figure 2). The rigidity features may be ribs that are made of materials that include UV cure adhesive, polyurethane, nylon, and polyester block amide dissolved in a solvent solution ([0063]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscopic device, specifically the distal end of the cannula and the housing, of Fructus with the elongated flex circuit, image processor, and controller as taught by Truckai ([0031] and [0036]). Doing so would connect the camera/image sensor and LEDs at the distal end of the cannula to the image processor and controller in the housing and would be an alternative to using wires for coupling ([0036]). It also would have been obvious to modify the ramp-shaped guiding element to be made of a UV cure adhesive as taught by Bonneau ([0063]). Doing so would provide a material with rigidity ([0063]). The modified device would have the ramp-shaped guiding element is made of a cured adhesive material (UV cure adhesive [0063]; Bonneau); a flexible printed circuit (FPC) (flex circuit [0036]; Truckai) that extends within the lumen (extend through passageway [0036]) of the cannula and electrically connects the camera and the one or more LEDs to electrical components located in the housing (the modified device would have a flex circuit for both the camera and LEDs for coupling to an image processor and controller; [0031] of Truckai); and wherein a thickness difference between the first and second ends (see 19, figure 2; Fructus) causes the ramp-shaped guiding element to guide the working tool away from electrical contacts of the camera to the FPC (see figure 2; Fructus), wherein the ramp-shaped guiding element is formed onto a surface of the FPC (UV cured adhesive [0063]; Bonneau | the UV cure adhesive/ramp-shaped guiding element 19 would be formed onto the surface of the FPC due to it being a “cure adhesive” and the FPC being located proximally of the viewing system 10, see figures 2 and 4 of Fructus) such that the cured adhesive material extends parallelly to the FPC and to a distal end portion of the cannula (see 112b rejection above | see location of 19 with respect to 10, figures 2 and 4; Fructus)
Regarding claim 2, Fructus further discloses the cannula defines a proximal opening (see tool 13 in cannula 5, figure 1; Fructus) and a distal opening (see 11-12, figure 2) that are respectively configured to allow the working tool to enter the lumen via the proximal opening and exit the lumen via the distal opening (see 13, figures 1-2).
Regarding claim 3, Fructus further discloses the electrical components in the housing include at least one of a printed circuit board (PCB), a display, a display cable (communicating with a unit…processing images [0037]; Fructus), and an electrical connection port (connection upstream to a source of electricity [0037]).
Regarding claim 4, Truckai further teaches the FPC is shaped to conform with an inner surface of the lumen (elongated flex circuit [0036] | the examiner interpreted the flexibility of the flex circuit would allow it to be shaped/conform to the inner surface of the lumen).
Regarding claim 5, Truckai further teaches the FPC is positioned within an upper third portion of the lumen (the modified device would have the flex circuit of Truckai positioned in the upper portion of 5, figure 1 of Fructus | see the top portion of 5 near 10, in figure 2).
Regarding claim 6, Fructus and Truckai discloses all of the features in the current invention as shown above in claim 1. They are silent regarding the working tool has a size of 5 French or smaller.
Truckai further teaches the working channel can receive various types of tools ([0034]). The diameter of the working channel can range from 1-6 mm ([0034]). The diameter of the tools can range from 1-3 mm ([0034]).
It would have been obvious to further modify the size of the diameter of the lumen as taught by Truckai ([0034]). Doing so would accommodate a variety of types of tools ([0034]). The modified device would have the working tool has a size of 5 French or smaller (based on the diameter of the working channel [0034]; Truckai).
Regarding claim 7, Fructus further discloses the tip element holds the one or more LEDs at the distal end of the cannula (see 10sub2, figure 2), and wherein the tip element is configured to: allow a sensor of the camera to sense reflected LED lights, and block other light from entering the sensor of the camera (see 10sub1 and 10sub2, figure 2).
Regarding claim 8, Fructus further discloses the tip element includes a partitioning wall that separates the camera from the one or more LEDs (see figures 1-2; 10sub1 and 10sub2 have separate channels/lumens they are disposed in).
Regarding claim 9, Fructus further discloses the partitioning wall extends from a lens of the camera to a proximal end of the camera where the camera connects to the FPC (see figures 1-2; 10sub1 and 10sub2 have separate channels/lumens they are disposed in).
Regarding claim 10, Fructus further discloses the tip element has a convex shape projecting outward from the distal end of the cannula (transverse face 8 could extend…inclined manner relative to the longitudinal axis [0036]).
Regarding claim 11, Fructus further discloses the tip element forms at least a portion of the tool channel (see figure 2).
Regarding claim 12, Fructus further discloses the tool channel has a curved inner surface that projects towards the camera (see 11-12, figures 1-2).
Regarding claim 13, Fructus further discloses the tip element holds the one or more LEDs at the distal end of the cannula (see 10sub2, figure 2), and wherein the cannula comprises: a shaft that forms the lumen (see 5 that contains the lumen for 13 to pass through, figures 1-2), and a coupler (see proximal portion of 7, figure 2) located between the shaft and the tip element, the coupler having a coupler notch that fits into a notch of a distal tip of the shaft to prevent the coupler from rotating relative to the distal tip (see how the distal portion of 5 is inserted and coupled to 7, figure 2; [0044]).
Regarding claim 15, Fructus further discloses the thickness of the ramp-shaped guiding element increases from the second end to the first end to protect the electrical contacts of the camera to the FPC from potential impacts caused by the working tool passing through the cannula towards the distal end of the cannula (see 19, figure 2).
Regarding claim 16, Fructus further discloses the cannula is a single-lumen cannula (see lumen in 5 for 13, figures 1-2).
Regarding claim 19, Fructus and Truckai further disclose the surface is a bottom surface of the FPC (see location of 19, figure 2; Fructus | flex circuit [0036]; Truckai | the modified device would have the bottom surface of the FPC secured to the ramp-shaped guiding element).
Regarding claim 21, Fructus and Truckai further disclose the ramp-shaped guiding element is formed onto the FPC within a nest (ramp-shaped guiding element 19 is within the nest that is above passage 12, see figures 2 and 4; Fructus | the modified FPC/ flex circuit [0036] of Truckai would be proximal of viewing system 10 in figures 2 and 4 of Fructus).
Claim(s) 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fructus (US 2011/0184233) and Truckai (US 2018/0184892) and Bonneau (US 2016/0235478) as applied to claim 13 above, and further in view of Adair (US 5,630,782).
Regarding claim 14, Fructus and Truckai and Bonneau disclose all of the features in the current invention as shown above in claim 13. They are silent regarding the coupler has a thread formed by a bulge in an inner surface of the coupler, the thread being arranged at about a location where the coupler meets the distal tip of the shaft.
Adair teaches an end cap (EC, figure 4) that attaches to capsule (C, figure 2) with threads (58 and 60, figures 4-6).
It would have been obvious to modify the inner surface of the coupler to have threads (see 60, figure 4; Adair) that engages the threads on the outer surface of the distal tip of the shaft (see distal end of 5, figure 1; Fructus). Doing so would be an alternative method for attaching (Col. 6, lines 30-36). The modified device would have the coupler has a thread formed by a bulge in an inner surface of the coupler (Col. 6, line 61; Adair), the thread being arranged at about a location where the coupler meets the distal tip of the shaft (see connection between 5 and 7, figure 2; Fructus).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 25 of U.S. Patent No. 12,082,783 in view of Bonneau (US 2016/0235478).
Regarding claim 1, Herriges discloses an endoscopic device, comprising: a housing (claim 1); a cannula (claim 1) configured to be inserted through a cervix into a uterus, the cannula having a lumen that extends from a proximal end of the cannula to a distal end of the cannula and that is configured to allow passage of a working tool (claim 1), and the proximal end of the cannula being secured within the housing (claim 1); an imaging system (claim 1) arranged at the distal end of the cannula, the imaging system comprising: a camera (claim 1), and one or more light-emitting diodes (LEDs) (claim 1) configured to provide light for the camera to acquire images of the uterus; and a flexible printed circuit (FPC) that extends within the lumen of the cannula and electrically connects the camera and the one or more LEDs to electrical components located in the housing (claim 1); a tip element that holds the camera at the distal end of the cannula (claim 1), wherein the tip element has a forward facing surface and is configured to be moved through the cervix in a forward direction (tip element…forward direction…forward facing surface; claim 1), the forward facing surface having an opening that exposes the camera at the distal end of the cannula (claim 1); and a ramp-shaped guiding element positioned inside the cannula (guiding element…ramp-shaped profile; claim 1), having a first end located proximate the tip element (claim 1), and having a second end located farther away from the tip element (proximal…farther away from the tip element; claim 1), wherein the ramp-shaped guiding element at least in part defines or is positioned adjacent to a tool channel configured to allow passage of the working tool (a cavity…working tool; claim 1), wherein the ramp-shaped guiding element has a thickness that changes between the first end and the second end (thickness difference…; claim 1), and wherein a thickness difference between the first and second ends causes the ramp-shaped guiding element to guide the working tool away from electrical contacts of the camera to the FPC (claim 1); wherein the ramp-shaped guiding element is formed onto a surface of the FPC (claim 25). Herriges is silent regarding the ramp-shaped guiding element is made of a cured adhesive material; wherein the cured adhesive material extends parallelly to the FPC and to a distal end portion of the cannula.
Bonneau teaches rigidity features of a proximal tapered portion (36, figures 2) of a balloon (24, figure 2). The rigidity features may be ribs that are made of materials that include UV cure adhesive, polyurethane, nylon, and polyester block amide dissolved in a solvent solution ([0063]).
It would have been obvious to modify the ramp-shaped guiding element to be made of a UV cure adhesive as taught by Bonneau ([0063]). Doing so would provide a material with rigidity ([0063]). The modified device would have the ramp-shaped guiding element is made of a cured adhesive material (UV cure adhesive [0063]; Bonneau); wherein the cured adhesive material ([0063]; Bonneau) extends parallelly to the FPC and to a distal end portion of the cannula (guide element…cavity that forms a channel….portion that is proximate the tip element….portion that is farther away from the tip element; claim 1; Herriges).
Regarding claim 2, Herriges further discloses the cannula defines a proximal opening and a distal opening that are respectively configured to allow the working tool to enter the lumen via the proximal opening and exit the lumen via the distal opening (claim 2).
Regarding claim 3, Herriges further discloses the electrical components in the housing include at least one of a printed circuit board (PCB), a display, a display cable, and an electrical connection port (claim 3).
Regarding claim 4, Herriges further discloses the FPC is shaped to conform with an inner surface of the lumen (claim 4).
Regarding claim 5, Herriges further discloses the FPC is positioned within an upper third portion of the lumen (claim 5).
Regarding claim 6, Herriges further discloses the working tool has a size of 5 French or smaller (claim 6).
Regarding claim 7, Herriges further discloses the tip element holds the one or more LEDs at the distal end of the cannula, and wherein the tip element is configured to: allow a sensor of the camera to sense reflected LED lights, and block other light from entering the sensor of the camera (claim 7).
Regarding claim 8, Herriges further discloses the tip element includes a partitioning wall that separates the camera from the one or more LEDs (claim 8).
Regarding claim 9, Herriges further discloses the partitioning wall extends from a lens of the camera to a proximal end of the camera where the camera connects to the FPC (claim 9).
Regarding claim 10, Herriges further discloses the tip element has a convex shape projecting outward from the distal end of the cannula (claim 10).
Regarding claim 11, Herriges further discloses the tip element forms at least a portion of the tool channel (claim 11).
Regarding claim 12, Herriges further discloses the tool channel has a curved inner surface that projects towards the camera (claim 12).
Regarding claim 13, Herriges further discloses the tip element holds the one or more LEDs at the distal end of the cannula (claim 13), and wherein the cannula comprises: a shaft that forms the lumen (claim 13), and a coupler located between the shaft and the tip element (claim 13), the coupler having a coupler notch that fits into a notch of a distal tip of the shaft to prevent the coupler from rotating relative to the distal tip (claim 13).
Regarding claim 14, Herriges further discloses the coupler has a thread formed by a bulge in an inner surface of the coupler, the thread being arranged at about a location where the coupler meets the distal tip of the shaft (claim 14).
Regarding claim 15, Herriges further discloses the thickness of the ramp-shaped guiding element increases from the second end to the first end to protect the electrical contacts of the camera to the FPC from potential impacts caused by the working tool passing through the cannula towards the distal end of the cannula (claim 15).
Regarding claim 16, Herriges further discloses the cannula is a single-lumen cannula (a lumen…; claim 1).
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 25, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights