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 .
Notice of Amendment
The RCE filed 1/2/2026 has been entered. Claims 14, 15, 18, 19, 21-23 are pending in the application with claims 14 and 19 amended, claims 1-13, 16, 17 cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US Patent Application Publication No. 2010/0030020) in view of Ouyang et al. (US Patent Application Publication No. 2020/0221932, hereinafter Ouyang), King et al. (US Patent Application Publication No. 2014/0275763, hereinafter King) and Deville et al. (US Patent Application Publication No. 2009/0240245, hereinafter Deville).
In regard to claim 14, Sanders discloses an endoscope (100, Fig. 1) comprising:
a single-use portion (102,104) comprising an elongated housing (102) that extends along a cannula axis (Fig. 1), and a cannula (104) that extends distally along the cannula axis (Fig. 1) and has an imaging module (Par. 54, camera disposed at the tip) at a distal end, and a pistol-grip handle that is integral with the housing to form therewith a single structure without releasable couplers and extends from the housing along a handle axis that is transverse to the cannula axis (Fig. 1, shows a pistol-grip handle transverse to the cannula axis devoid of couplers between the housing and the pistol-grip handle) and is hollow and has an open distal end (lid (120) is capable of opening to expose the interior of the pistol-grip handle), wherein the single-use portion is free of releasable couplers between the pistol-grip handle and the remainder of the single-use portion (Fig. 1):
wherein said single-use portion further comprises:
a proximal port (118) that is at a proximal end thereof and is in line with said cannula axis (Fig. 1), and a distal port at the distal end of the cannula (via distal opening at the tip of the cannula);
an internal lumen that is in line with said cannula axis and is in fluid flow communication with said proximal and distal ports (via channel connecting the working channel opening to the distal tip opening of the cannula, Fig. 2a);
a first electrical contact (via connectors of power/video cables that mate with connector (431) of the cartridge, Par. 50) inside said hollow handle, at a proximal end thereof, that is operatively connected with said imaging module (Par. 50);
a cap (120) that is configured to removably close said open distal end of the handle (Figs. 1-2, Par. 49);
a reusable portion (210) configured for insertion into said hollow handle after said cap is hand-manipulated to open the open end of the hollow handle (Figs. 1-2, Par. 49);
wherein said reusable portion comprises a second electrical contact configured to mate electrically with said first electrical contact and further comprises electronics configured to control said imaging module and to receive and process image data from said imaging module through said first and second electrical contacts when the reusable portion is inserted in said hollow handle and provide resulting image data for display (Par. 50, via mating between connector (431) with power video cables within the handle);
wherein the reusable portion has a length of which at least ¾ are received inside the handle when said first and second electrical contacts have mated (Figs. 1, 2b); and
said cap is configured to cover the open end of the handle and an adjacent part of the reusable portion after insertion of the reusable portion in the handle to assemble the endoscope (Figs. 1, 2b, Par. 49).
Sanders does not expressly teach a fluid hub that extends distally from the housing along the cannula axis, an intermediate port at said fluid hub in fluid flow communication with internal lumen.
Ouyang teaches an analogous endoscope comprising a shaft (400) and handle (140), the shaft having a proximal port (130), an intermediate port (132, i.e. fluid hub) and a distal opening within the tip (110). Each of the proximal port, intermediate port and distal opening are in fluid communication with an internal channel of the shaft (Par. 78). The intermediate port enabling fluid to be introduced through the internal channel and exit through the distal opening to a surgical space.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the cannula of Sanders with the intermediate port of Ouyang enabling fluid and surgical instruments to be introduced simultaneously into the surgical space via the internal channel of the cannula.
Sanders does not expressly teach a sterile pouch enclosing said single-use portion, with the cap closing the open end of the hollow handle.
King teaches an analogous endoscope (100) comprising a handle (102) and shaft (104). The shaft comprises an image sensor at the distal end (Par. 61) and the handle includes a removable control module (112) including a battery and contacts (164) for engaging contacts within the handle for transmitting data between the image sensor and the control module (Par. 63,134). The control module is inserted within upper and lower housing (120,122) and closed off at the end of the housing via hinged cap (114). King further teaches the end cap can contain rubber or silicon on its mating surfaces to provide a seal between the end cap and the housing (Par. 89). Additionally, King teaches the endoscope, which includes the handle (102) and shaft (104) can be stored in sterile packaging prior to use (Par. 137).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Sanders within the sterile packaging of King ensuring the endoscope remains in a sterile environment prior to a surgical procedure thereby reducing the risk of infection to a patient.
Sanders, Ouyang and King do not expressly teach wherein the handle and the reusable portion are dimensionally shaped such that a first interior side of the hollow interior of the handle and a first side of the reusable portion have a first dimension and a second interior side of the hollow interior of the handle and a second side of the reusable portion have a second dimension that is different from the first dimension, and such that a distal end of the reusable portion is larger than a proximal end of the reusable portion so that the reusable portion can be inserted into the handle in only one direction.
Deville teaches an analogous surgical instrument with a removable battery (3500, Fig. 36). The removable battery includes a trapdoor such that when the trapdoor is released via a trapdoor button (3320), the battery is partially ejected from the handle enabling easier removable of the battery from the handle for operating room staff (Par. 177). As can be seen in annotated Fig. 36 below, the battery composes a plurality of sides having different dimensions as well as a distal end of the battery having a larger dimension than the proximal and side thereby only allowing the battery to be inserted within the handle proximal end first.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the handle and battery of Sanders with the trapdoor and trapdoor flange of Deville enabling the battery to be automatically partially ejected from the handle when the trapdoor is released to provide easier removal of the battery by operating room staff (Par. 177).
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In regard to claim 15, Sanders teaches wherein the reusable portion has at least two rounded sides and one of the rounded sides is curved more than another of the rounded sides (Fig. 2a shows the reusable portion having a plurality of contours with some contours being more rounded than others).
In regard to claim 18, Sanders teaches that the cartridge can communicate wirelessly with external components but does not expressly teach further comprising an external processing/display unit having an image display and connected with the reusable portion wirelessly or by cable to receive and display image data from said imaging module.
King teaches an analogous endoscope (100) comprising a handle (102) and shaft (104). The shaft comprises an image sensor at the distal end (Par. 61) and the handle includes a removable control module (112) including a battery and contacts (164) for engaging contacts within the handle for transmitting data between the image sensor and the control module (Par. 63,134). The control module is inserted within upper and lower housing (120,122) and closed off at the end of the housing via hinged cap (114). King further teaches the end cap can contain rubber or silicon on its mating surfaces to provide a seal between the end cap and the housing (Par. 89). King further teaches the removable control module (112) can communicate with an external computing device (188) comprising a computer and video monitor for displaying images or video from the endoscope (Par. 144).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Sanders with external computing device (188) of King enabling the surgeon or remote physician to monitor the surgical procedure on the external display.
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US Patent Application Publication No. 2010/0030020) in view of Ouyang et al. (US Patent Application Publication No. 2020/0221932, hereinafter Ouyang) and Miller et al (US Patent Application Publication No. 2008/0215056, hereinafter Miller) and Deville et al. (US Patent Application Publication No. 2009/0240245, hereinafter Deville).
In regard to claim 19, Sanders discloses an endoscope (100, Fig. 1) comprising:
a single-use portion (102,104) comprising an elongated housing (102) that extends along a cannula axis, a cannula (104) that extends distally from the housing along the cannula axis (Fig. 1) and has an imaging module (Par. 54, camera disposed at the tip) at a distal end, and a hollow pistol-grip handle that is integral with the housing forming therewith a single structure without releasable couplers, extends from the housing along a handle axis that is transverse to the cannula axis (Fig. 1 shows a pistol-grip handle transverse to the cannula axis devoid of couplers between the housing and the pistol-grip handle), and has an open distal (lid (120) is capable of opening to expose the interior of the pistol-grip handle):
wherein said single-use portion further comprises:
a proximal port (118) that is at a proximal end thereof and in line with said cannula axis, a distal port (via opening in tip (106)) at the distal end of the cannula (Fig. 1), and;
an internal lumen (via lumen connecting the proximal and distal ports) that is in line with the cannula axis and is in fluid flow communication with said proximal and distal ports (Fig. 1, 2a);
a reusable portion (210) configured for manual insertion of a proximal part thereof into the hollow handle through said open distal end of the handle (Fig. 2a);
wherein said reusable portion comprises electronics operatively coupled with said imaging module when the reusable portion is inserted in the handle and configured to control said imaging module and to receive and process image data from said imaging module and provide resulting images for display (Par. 50);
a cover (120) configured to fit over the open end of the hollow handle before insertion of the reusable portion in the handle (Figs. 1, 2a).
Sanders does not expressly teach an intermediate port between said proximal and distal ports and an intermediate port in fluid flow communication with the internal lumen.
Ouyang teaches an analogous endoscope comprising a shaft (400) and handle (140), the shaft having a proximal port (130), an intermediate port (132) and a distal opening within the tip (110). Each of the proximal port, intermediate port and distal opening are in fluid communication with an internal channel of the shaft (Par. 78). The intermediate port enabling fluid to be introduced through the internal channel and exit through the distal opening to a surgical space.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the cannula of Sanders with the intermediate port of Ouyang enabling fluid and surgical instruments to be introduced simultaneously into the surgical space via the internal channel of the cannula.
Sanders does not expressly teach such that a protruding distal portion of the reusable portion protrudes distally from the handle, wherein said reusable portion has a length of which less than ¼ forms said protruding portion and to cover the protruding part of the reusable portion and an adjacent portion of the handle after insertion of the reusable part in the handle.
Miller teaches an analogous surgical device having a pistol grip handle (36) with a removable battery pack (34) within a hollow portion of the handle. A portion of the removable battery pack (34) protrudes from an end of the handle less than ¼ the total length of the removably battery pack and is closed off by a removable cap (38).
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to provide the cartridge of Sanders to protrude from the handle and be covered by the cap as taught by Miller as a matter of design choice since Sanders and Miller both teach of power sources removably coupled to a pistol grip handle of a surgical device. There being no unexpected results in modifying the cartridge of Sanders to slightly protrude from the handle as taught by Miller.
Sanders, Ouyang and Miller do not expressly teach wherein the handle and the reusable portion are dimensionally shaped such that a first interior side of the hollow interior of the handle and a first side of the reusable portion have a first dimension and a second interior side of the hollow interior of the handle and a second side of the reusable portion have a second dimension that is different from the first dimension, and such that the distal portion of the reusable portion is larger than the proximal part of the reusable portion so that the reusable portion can be inserted into the handle in only one direction.
Deville teaches an analogous surgical instrument with a removable battery (3500, Fig. 36). The removable battery includes a trapdoor such that when the trapdoor is released via a trapdoor button (3320), the battery is partially ejected from the handle enabling easier removable of the battery from the handle for operating room staff (Par. 177). As can be seen in annotated Fig. 36 below, the battery composes a plurality of sides having different dimensions as well as a distal end of the battery having a larger dimension than the proximal and side thereby only allowing the battery to be inserted within the handle proximal end first.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the handle and battery of Sanders with the trapdoor and trapdoor flange of Deville enabling the battery to be automatically partially ejected from the handle when the trapdoor is released to provide easier removal of the battery by operating room staff (Par. 177).
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In regard to claim 21, Sanders teaches in which the reusable handle has at least two rounded sides and one of the rounded sides is curved more than another or the rounded sides (Fig. 2a shows the reusable portion having a plurality of contours with some contours being more rounded than others).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US Patent Application Publication No. 2010/0030020) in view of Ouyang et al. (US Patent Application Publication No. 2020/0221932, hereinafter Ouyang), Miller et al (US Patent Application Publication No. 2008/0215056, hereinafter Miller) and Deville et al. (US Patent Application Publication No. 2009/0240245, hereinafter Deville)., as applied to claim 19, and further in view of King et al. (US Patent Application Publication No. 2014/0275763, hereinafter King).
In regard to claims 22 and 23, Sanders further comprising an external processing/display unit having an image display and connected with the reusable portion wirelessly or via cable to receive and display image data from said imaging module.
King teaches an analogous endoscope (100) comprising a handle (102) and shaft (104). The shaft comprises an image sensor at the distal end (Par. 61) and the handle includes a removable control module (112) including a battery and contacts (164) for engaging contacts within the handle for transmitting data between the image sensor and the control module (Par. 63,134). The control module is inserted within upper and lower housing (120,122) and closed off at the end of the housing via hinged cap (114). King further teaches the end cap can contain rubber or silicon on its mating surfaces to provide a seal between the end cap and the housing (Par. 89). King further teaches the removable control module (112) can communicate with an external computing device (188) via wirelessly (Par. 142) or by cable (Par. 135), the computing device comprising a computer and video monitor for displaying images or video from the endoscope (Par. 144).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope of Sanders with external computing device (188) of King enabling the surgeon or remote physician to monitor the surgical procedure on the external display, wherein the endoscope can communicate the external computing device either wirelessly or via cable (Par. 135, 142).
Response to Arguments
Applicant's arguments filed 1/2/2026 have been fully considered but they are not persuasive.
Applicant argues Deville fails to teach "the handle and the reusable portion are dimensionally shaped such that a first interior side of the hollow interior of the handle and a first side of the reusable portion have a first dimension and a second interior side of the hollow interior of the handle and a second side of the reusable portion have a second dimension that is different from the first dimension, and such that a distal end of the reusable portion is larger than a proximal end of the reusable portion so that the reusable portion can be inserted into the handle in only one direction" as recited in claim 14 and 19, specifically "handle and the reusable portion are dimensionally shaped.. so that the reusable portion can be inserted into the handle in only one direction" as recited in claim 14 and 19.
The examiner disagrees since annotated Fig. 36 below shows the first and second dimensions being different from each other as well as the battery only able to be inserted within the handle proximal end first due to the larger dimensions of the distal end of the battery.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 March 13, 2026