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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 110, described beginning in par. 0042, as a rotatable sleeve. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9 and 20 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 claims 9 and 20, it is unclear how a “rotation tab” can be associated with the filter sleeve, and effect rotation of the rotatable sleeve. For the purposes of examination, the rotation tab will be interpreted as interfacing with the rotatable sleeve.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Worrell et al. (US 20150080876).
Regarding claim 1, Worrell et al. discloses a surgical grasper configured to evacuate fluids from a surgical site (illustrated generally in fig. 1A, utilizing the specific embodiment of fig. 4A-B), comprising: a housing 7/18 defining an interior cavity (“fluid path” provided through housing 18 of handle 7; see par. 0058-0060); an elongated shaft (4 in fig. 1; 104’ in fig. 4A-B) extending distally from the housing (see fig. 1) and defining a lumen 123a’ in fluid communication with the interior cavity defined by the housing (see fig. 1 and fig. 4A; par. 0058-0060); a distal cap disposed at a distal end of the elongated shaft (distal face of shaft 110’; see fig. 4A); an end effector 113’ including a first jaw member 115a’ and a second jaw member 115b’, the first and second jaw members having a distal portion configured to grasp tissue (portion to the right in fig. 4A where working portions 117a’ and b’ are located) and a proximal portion pivotably coupled to the distal cap (portion coupled to the face of 110’); and at least one suction hole 125a’ defined through the distal cap, the at least one suction hole in fluid communication with the lumen defined by the elongated shaft for evacuating fluid from a surgical site (see fig. 4A; par. 0072).
Regarding claim 2, Worrell et al. discloses a handle 20c coupled to the housing (see fig. 1) and configured to pivot at least one of the first or second jaw members relative to the other jaw member to transition the end effector between a closed configuration wherein the first and second jaw members are approximated to grasp tissue and an open configuration wherein the first and second jaw members are spaced apart (par. 0057).
Regarding claim 3, Worrell et al. discloses a fluid flow path extending from the at least one suction hole, thorough the lumen defined by the elongated shaft, and through the interior cavity of the housing (flow path defined by 125a’, 123a’, and connected “fluid path” inside 7/18 as described in par. 0058-0060).
Regarding claim 4, Worrell et al. discloses a fluid port (one of proximal fluid ports 24, par. 0058) extending from an outer surface of the housing, the fluid port configured to be coupled to a tube for placing the surgical grasper in fluid communication with a suction source (fluid port 24 fully capable of being coupled to a tube and used as claimed; see par. 0058-0063).
Regarding claim 6, Worrell et al. discloses the elongated shaft, the distal cap, and the end effector are configured to be inserted through a surgical access device inserted through patient tissue to access a peritoneal cavity (configuration illustrated in fig. 1 is fully capable of performing this claimed function).
Regarding claim 10, Worrell et al. discloses the surgical grasper is configured to be attached to a surgical robot arm of a robotic surgical system (configuration illustrated in fig. 1 is fully capable of performing this claimed function).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. in view of Lucey et al. (US 5620415).
Regarding claim 5, Worrell et al. discloses a rotation knob 20b configured to rotate the end effector, but fails to disclose that the knob rotates the end effector and the distal cap relative to the elongated shaft about a longitudinal axis defined by the elongated shaft. However, Lucey et al. teaches a combination of a cap 60 end effector (jaws 28 and 30, attached 60), cap 60 including a suction hole (“throat” through the jaws; fig. 2; col. 10, ln. 64 – col. 11, ln. 9), where a rotation knob 26 rotates both the cap and the end effector relative to the elongated shaft 14 (col. 5, ln. 11-27). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Worrell et al. surgical grasper to utilize a combined rotatable cap/end effector, as taught by Lucey et al., for the purpose of providing sufficient structure to enable positional adjustment of the surgical end effector without the need to rotate the entire surgical instrument, avoiding complications associated therewith (col. 2, ln. 10-28).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. in view of Wu (CN 111329577).
Regarding claim 17, Worrell et al. discloses a surgical grasper configured to evacuate fluids from a surgical site (illustrated generally in fig. 1A, utilizing the specific embodiment of fig. 4A-B), comprising: a housing 7/18 defining an interior cavity (“fluid path” provided through housing 18 of handle 7; see par. 0058-0060); an elongated shaft (4 in fig. 1; 104’ in fig. 4A-B) extending distally from the housing (see fig. 1) and defining a lumen 123a’ in fluid communication with the interior cavity defined by the housing (see fig. 1 and fig. 4A; par. 0058-0060); a distal cap disposed at a distal end of the elongated shaft (distal face of shaft 110’; see fig. 4A); an end effector 113’ including a first jaw member 115a’ and a second jaw member 115b’, the first and second jaw members having a distal portion configured to grasp tissue (portion to the right in fig. 4A where working portions 117a’ and b’ are located) and a proximal portion pivotably coupled to the distal cap (portion coupled to the face of 110’); and at least one suction hole 125a’ defined through the distal cap, the at least one suction hole in fluid communication with the lumen defined by the elongated shaft for evacuating fluid from a surgical site (see fig. 4A; par. 0072), and providing for a filter in the flow path (par. 0047), except for disclosing a filter sleeve disposed within the lumen defined by the elongated shaft and configured to filter fluid from the surgical site. Wu teaches providing a filter sleeve 6 in the flow path flowing from the distal end of an electro-coagulation device (see fig. 3; see first paragraph under “(2) technical solution” in the translated document and the description of fig. 1-5 under “Specific implementation methods” in the translated document). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a filter sleeve, as taught by Wu, for the purpose of providing sufficient structure to prevent escape of unwanted particles from the flow path.
Claim(s) 7, 8, 11-14, 16, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. in view of Wu and Herlitze (EP 0007602).
Regarding claims 7 and 8, Worell et al. discloses the surgical grasper as claimed, including providing for a filter in the flow path (par. 0047), except for specifically disclosing the filter is a filter sleeve disposed within the lumen defined by the elongated shaft, the elongated shaft defining at least one first window configured to expose the filter sleeve; and a rotatable sleeve coaxially surrounding the elongated shaft and configured to be rotated about a longitudinal axis defined by the elongated shaft, the rotatable sleeve defining at least one second window configured to be axially misaligned or at least partially axially aligned with the at least one first window to control fluid flow through the filter sleeve.
Wu teaches providing a filter sleeve 6 in the flow path flowing from the distal end of an electro-coagulation device (see fig. 3; see first paragraph under “(2) technical solution” in the translated document and the description of fig. 1-5 under “Specific implementation methods” in the translated document). Herlitze further teaches providing, in a suction conduit, a window 7 (fig. 2) for suction regulation (see third paragraph under “Description” in the translated document) and a rotatable sleeve 6 coaxially surrounding the elongated shaft and configured to be rotated about a longitudinal axis defined by the elongated shaft (embodiment partially illustrated in fig. 2, rotatable as described in the final two paragraphs under “Description” in the translated document), the rotatable sleeve defining at least one second window configured to be axially aligned/misaligned with the first window to control fluid flow therethrough (“longitudinally slotted sleeve”, see final paragraph under “Description” in the translated document). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical grasper of Worrell et al. to utilize, as its filter, a filter sleeve as taught by Wu in combination with a window and rotatable sleeve arrangement as taught by Herlitze, for the purpose of providing sufficient structure to enable manual suction regulation as taught by Herlitze while preventing the expulsion of unwanted particles from the flow path, as desired by Worrell et al. and further taught by Wu.
Regarding claims 11, 18, and 19, Worrell et al. discloses a surgical grasper configured to evacuate fluids from a surgical site (illustrated generally in fig. 1A, utilizing the specific embodiment of fig. 4A-B), comprising: a housing 7/18 defining an interior cavity (“fluid path” provided through housing 18 of handle 7; see par. 0058-0060); an elongated shaft (4 in fig. 1; 104’ in fig. 4A-B) extending distally from the housing (see fig. 1) and defining a lumen 123a’ in fluid communication with the interior cavity defined by the housing (see fig. 1 and fig. 4A; par. 0058-0060); an end effector 113’ including a first jaw member 115a’ and a second jaw member 115b’, the first and second jaw members having a distal portion configured to grasp tissue (portion to the right in fig. 4A where working portions 117a’ and b’ are located); and providing a filter in the flow path (par. 0047), except for disclosing a filter sleeve disposed within the lumen defined by the elongated shaft and configured to filter fluid from a surgical site; at least one first window extending longitudinally along at least a portion of the elongated shaft and configured to expose the filter sleeve; a rotatable sleeve coaxially surrounding the elongated shaft and configured to be rotated about a longitudinal axis defined by the elongated shaft; and at least one second window extending longitudinally along at least a portion of the rotatable sleeve, wherein rotation of the rotatable sleeve is configured to rotate the at least one second window into axial misalignment with the at least one first window to prevent fluid flow through the filter sleeve or at least partial axial alignment with the at least one first window to at least partially expose the filter sleeve for facilitating fluid flow through the filter sleeve.
Wu teaches providing a filter sleeve 6 in the flow path flowing from the distal end of an electro-coagulation device (see fig. 3; see first paragraph under “(2) technical solution” in the translated document and the description of fig. 1-5 under “Specific implementation methods” in the translated document). Herlitze further teaches providing, in a suction conduit, a window 7 (fig. 2) for suction regulation (see third paragraph under “Description” in the translated document) and a rotatable sleeve 6 coaxially surrounding the elongated shaft and configured to be rotated about a longitudinal axis defined by the elongated shaft (embodiment partially illustrated in fig. 2, rotatable as described in the final two paragraphs under “Description” in the translated document), the rotatable sleeve defining at least one second window configured to be axially aligned/misaligned with the first window to control fluid flow therethrough (“longitudinally slotted sleeve”, see final paragraph under “Description” in the translated document). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical grasper of Worrell et al. to utilize, as its filter, a filter sleeve as taught by Wu in combination with a window and rotatable sleeve arrangement as taught by Herlitze, for the purpose of providing sufficient structure to enable manual suction regulation as taught by Herlitze while preventing the expulsion of unwanted particles from the flow path, as desired by Worrell et al. and further taught by Wu.
Regarding claim 12, Worrell et al. discloses a handle 20c coupled to the housing (see fig. 1) and configured to pivot at least one of the first or second jaw members relative to the other jaw member to transition the end effector between a closed configuration wherein the first and second jaw members are approximated to grasp tissue and an open configuration wherein the first and second jaw members are spaced apart (par. 0057).
Regarding claim 13, Worrell et al. discloses a fluid flow path extending from the at least one suction hole, thorough the lumen defined by the elongated shaft, and through the interior cavity of the housing (flow path defined by 125a’, 123a’, and connected “fluid path” inside 7/18 as described in par. 0058-0060).
Regarding claim 14, Worrell et al. discloses a fluid port (one of proximal fluid ports 24, par. 0058) extending from an outer surface of the housing, the fluid port configured to be coupled to a tube for placing the surgical grasper in fluid communication with a suction source (fluid port 24 fully capable of being coupled to a tube and used as claimed; see par. 0058-0063).
Regarding claim 16, Worrell et al. discloses the elongated shaft, the distal cap, and the end effector are configured to be inserted through a surgical access device inserted through patient tissue to access a peritoneal cavity (configuration illustrated in fig. 1 is fully capable of performing this claimed function).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. in view of Wu and Herlitze, and further in view of Lucey et al.
Regarding claim 15, Worrell et al. discloses a rotation knob 20b configured to rotate the end effector, but fails to disclose that the knob rotates the end effector and the distal cap relative to the elongated shaft about a longitudinal axis defined by the elongated shaft. However, Lucey et al. teaches a combination of a cap 60 end effector (jaws 28 and 30, attached 60), cap 60 including a suction hole (“throat” through the jaws; fig. 2; col. 10, ln. 64 – col. 11, ln. 9), where a rotation knob 26 rotates both the cap and the end effector relative to the elongated shaft 14 (col. 5, ln. 11-27). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Worrell et al. surgical grasper to utilize a combined rotatable cap/end effector, as taught by Lucey et al., for the purpose of providing sufficient structure to enable positional adjustment of the surgical end effector without the need to rotate the entire surgical instrument, avoiding complications associated therewith (col. 2, ln. 10-28).
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. in view of Wu and Herlitze, and further in view of Minskoff et al. (US 20160114088).
Regarding claims 9 and 20, as best understood, Herlitze, modifying Worrell et al., teaches a manually rotatable sleeve, but fails to teach a rotation tab extending from the filter sleeve and configured for enabling a user to manually rotate the rotatable sleeve about a longitudinal axis defined by the elongated shaft. However, Minskoff et al. teaches, in a movable suction control element 2016 (fig. 20B) utilizing ridges protruding from the body of the movable suction control element 2016 (see fig. 20B, unlabeled ridges). Minskoff et al. further teaches that suction control elements may be movable either by sliding or rotating (par. 0169). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a rotation tab in the rotatable sleeve of Worrell modified by Wu and Herlitze in order to provide sufficient structure to allow gripping of the surface of the rotatable sleeve to achieve its desired movement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783