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 .
Response to Amendment
As of the reply filed 7/06/2026, claims 1-12, 15-17, and 23-24 are pending. Claims 13-14 and 18-22 are cancelled. Claims 1, 3,-5, 8-12, and 15-17 have been amended. Claims 23-24 are new.
Response to Arguments
Applicant’s amendments to claims 17-18 to renumber them as claims 16-17 overcomes the previously filed claim objection due to the misnumbering of the claims. Applicant’s cancellation of withdrawn claims 18-22 also overcomes this. The claim objections due to misnumbered claims are withdrawn.
Applicant’s amendments to claims 1-5, 8-11, 15, and 17-18 and the cancellation of claim 14 has overcome most of the claim objections as previously set forth, therefore these claim objections are withdrawn. However, Applicant’s reply failed to address each and every claim objection and those claim objections that were not resolved are included below. Furthermore, additional claim objections apply in view of Applicant’s amendments.
Applicant’s amendments to claim 1 has obviated the previous claim interpretation of “locking mechanism” under 35 U.S.C. 112(f), therefore this interpretation is withdrawn.
Applicant’s amendment to claim 11 has overcome the previously filed rejection under 35 U.S.C. 112(b), therefore this rejection is withdrawn.
Applicant’s arguments with respect to amended claim 1 are acknowledged, but are moot because the new ground of rejection relies on a new reference to teach the amended limitations.
Applicant’s arguments with respect to newly added claim 23 are acknowledged, but unpersuasive. Applicant argues that the claimed locking tab including “an opening with two different fixed diameter portions” overcomes the prior art, but the Examiner respectfully disagrees. Pacak et al. teaches a locking tab (241 in Fig. 15) comprising an opening including two separate fixed diameter portions (see Fig. 15 where the first diameter is defined by 244 and the second diameter is defined by 254) wherein when the locking tab is moved into an inward locking position, the second diameter portion (254) is configured to be positioned within a groove of the guide tube (T). By interpreting the inner mechanisms shown in Fig. 15 to be part of the locking tab, Pacak et al. reads on the claim.
Applicant's arguments regarding newly added claim 24 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The patient-engaging surface as discussed and claimed by the Applicant can be considered to be the downward-facing surface of the device and its components as a whole, and the Examiner argues that Pacak et al. reads on this language since the flange portions (213 and 214) form at least a portion of the patient side of the skin bumper (202) by having a distal-facing surface.
Claim Objections
Claims 1, 4, 9, 11, 17, and 23-24 are objected to because of the following informalities:
Claim 1, line 13: “and from a seal therewith” is grammatically incorrect and should be amended to recite “and form a seal therewith” instead.
Claim 4, lines 1, 3, and 4: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 9, line 1: “the locking tab” should be amended to recite “the lock” in order to match the change to claim 1.
Claim 11, lines 4 and 5: each instance of “the locking tab” should be amended to recite “the lock” in order to match the change to claim 1.
Claim 17, line 3: “the sheath” should match the original naming basis and be amended to recite “the flexible sheath” instead.
Claim 23, third from the last line: “the second diameter portion is position withing” does not make sense, it is recommended this limitation be amended to recite “the second diameter portion is positioned within” instead.
Claim 24, line 14: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 24, line 16: “a flange first portion” is grammatically incorrect and should be amended to recite “a first flange portion” instead.
Claim 24, line 17: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 24, line 17: “the flange first portion” is grammatically incorrect and should be amended to recite “the first flange portion” instead.
Claim 24, lines 18-19: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 23 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pacak et al. (US PGPub 2020/0060719 A1).
With respect to claim 23, Pacak et al. discloses an anorectal junction device (see Figs. 12A-21, since the device contains all of the described structures and is configured for insertion into a body opening of a patient for securing instruments inserted therethrough it can be considered an anorectal junction device) comprising:
a guide tube (T in Fig. 12A) having a distal and proximal end defining a lumen there between (see lumen through T, see also Fig. 17), the lumen adapted to receive there through an endoscope (see lumen in Fig. 17, it is adapted to receive an endoscope);
a rectal bumper (204 in Fig. 12A) formed of a resilient material disposed on the guide tube distal end (see Fig. 12A, 204 is on a distal end of T), the rectal bumper (204) adapted to sealing engage rectal tissue when the guide tube (T) is inserted in a patient (PP [0127]: “for engaging the interior of the body of the patient”, since bumper 204 device of Pacak et al. is adapted to engage an opening in a patient it is adapted to sealingly engage rectal tissue since it is a material configured for insertion through a body opening that the anus of a patient can sealingly compress, see MPEP 2112.01);
a skin bumper (202) slidably disposed over the guide tube (T, see Figs. 12A-B, the skin bumper (202) being adapted to engage an intergluteal cleft of the patient (202 is adapted to sit outside of a body opening and is adapted to engage an intergluteal cleft, see MPEP 2112.01), the skin bumper (202) a seal with the patient (202 is configured to seal against a patient because it is adapted to sit outside of a body opening and is made of a rigid material which the anus of a patient can sealingly compress, see MPEP 2112.01); and
a lock (207 interacting T, see Fig. 15) including a movable member (241) for selectively locking the position of the skin bumper (202) relative to the guide tube (T, see PP [0139]), the lock (207) includes a plurality of longitudinally spaced annular grooves (see unmarked grooves on T in Fig. 17) formed on a guide tube outer wall (T), the grooves each having a diameter less than the outside diameter of the guide tube (see unmarked grooves on T in Fig. 17, there are portions with a smaller relative diameter than others, PP [0063]: “the annular expandable member includes a sleeve slightly bigger than the trocar with an internal peripheral rib which engages over a rib on the trocar to lock the annular expandable member in place”, the outside diameter of the guide tube/trocar T includes the ribs, and the grooves have a diameter that is less than the outside diameter), the movable member including a locking tab (241) selectively engageable with the guide tube (PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”, PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”), the locking tab (241) having a surface defining an opening through which the guide tube extends (see Fig. 14 showing opening through 241, see also Fig. 15 where T is configured to extend through 254 within the opening through 241), the opening having a first fixed diameter portion and a second fixed diameter portion being larger than an outside diameter of the guide tube (T, see Fig. 15 where the opening through 241 has multiple diameters defined by 244 and 254, respectively, as first and second diameter portions) wherein when the locking tab (241) is moved into a locking position the second diameter portion (254) is position withing one of the plurality of grooves (254 which defines the second diameter portion is configured to be positioned within one of the unmarked grooves on T in Fig. 17) wherein the skin bumper position (202) is positionally fixed relative to the guide tube (T, PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”, PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”).
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.
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.
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.
Claims 1-12, 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US PGPub 2020/0060719 A1) in view of Starnes (US PGPub 2015/0201944 A1).
With respect to claim 1, Pacak et al. discloses an anorectal junction device (see Figs. 12A-21, since the device contains all of the described structures and is configured for insertion into a body opening of a patient for securing instruments inserted therethrough it can be considered an anorectal junction device) comprising:
a guide tube (T in Fig. 12A) having a distal and proximal end defining a lumen there between (see lumen through T, see also Fig. 17), the lumen adapted to receive there through an endoscope (see lumen in Fig. 17, it is adapted to receive an endoscope);
a rectal bumper (204 in Fig. 12A) formed of a resilient material disposed on the guide tube distal end (see Fig. 12A, 204 is on a distal end of T), the rectal bumper (204) adapted to sealing engage rectal tissue when the guide tube (T) is inserted in a patient (PP [0127]: “for engaging the interior of the body of the patient”, since bumper 204 device of Pacak et al. is adapted to engage an opening in a patient it is adapted to sealingly engage rectal tissue since it is a material configured for insertion through a body opening that the anus of a patient can sealingly compress, see MPEP 2112.01);
a skin bumper (202) slidably disposed over the guide tube (T, see Figs. 12A-B, the skin bumper (202) being adapted to engage an intergluteal cleft of the patient (202 is adapted to sit outside of a body opening and is adapted to engage an intergluteal cleft, see MPEP 2112.01), the skin bumper (202) a seal with the patient (202 is configured to seal against a patient because it is adapted to sit outside of a body opening and is made of a rigid material which the anus of a patient can sealingly compress, see MPEP 2112.01); and
a lock (207 interacting T, see Fig. 15) for selectively locking the position of the skin bumper (202) relative to the guide tube (T, see PP [0139]).
However, Pacak et al. fails to disclose a scope abutment apparatus disposed on the proximal end of the guide tube, the scope abutment apparatus adapted to selectively engage the endoscope and [form] a seal therewith, the scope abutment apparatus including a base having a resilient bushing disposed therein, the bushing having a central opening, the bushing having an adjustable inner diameter, and a knob being threadedly secured to the base, the knob including an opening coaxially aligned with the bushing central opening, the bushing central opening and the knob opening adapted to receive the endoscope there through, and wherein the knob is movable between a compressed position where the bushing central opening is reduced in diameter to restrict movement of the endoscope and a released position wherein the bushing central opening permits movement of the endoscope.
In the related filed of occlusion catheter systems (abstract), which is related due to its concern with guiding and deploying shafted surgical tools within a body lumen, Starnes teaches a guide tube (124 of 100 in Fig. 1) comprising a scope abutment apparatus (114, 142, and 140, see also Fig. 4) disposed on the proximal end of the guide tube (124 in Fig. 1), the scope abutment apparatus (114, 142, and 140 in Fig. 4) adapted to selectively engage an endoscope and for a seal therewith (PP [0025]: “A portion of the force from the seat portion 148 can act inwardly against the resilient member 144 to cause the diameter of bore 154 to resiliently decrease and/or to cause the resilient member 144 to resiliently deform and press against the catheter 102 when the catheter 102 is positioned within the bore 154”), the scope abutment apparatus (see Fig. 4) including a base (142) having a resilient bushing (144) disposed therein, the bushing (144) having a central opening (154), the bushing (144) having an adjustable inner diameter (PP [0025]: “A portion of the force from the seat portion 148 can act inwardly against the resilient member 144 to cause the diameter of bore 154 to resiliently decrease”), and a knob (140) being threadedly secured to the base (142, see threads 156 and 158), the knob (140) including an opening coaxially aligned with the bushing central opening (see unmarked opening through 140 aligned with and in communication with bore 154), the bushing central opening and the knob opening (opening through 140 and 144 including 154) adapted to receive the endoscope there through (154 can receive a catheter 102, see Fig. 1, and is also adapted to receive an endoscope), and wherein the knob (140) is movable between a compressed position where the bushing central opening (154) is reduced in diameter to restrict movement of the endoscope and a released position wherein the bushing central opening (154) permits movement of the endoscope (PP [0024]: “When the locking nut 140 is rotated in one direction relative to the housing 142, the cylindrical portion 152 can move into the groove 150 such that the stem portion 146 presses the resilient member 144 against the seat portion 148. When the locking nut 140 is rotated in an opposite direction relative to the housing 142, the cylindrical portion 152 can move out of the groove 150 to cause the stem portion 146 to release the resilient member 144”, PP [0025]: “A portion of the force from the seat portion 148 can act inwardly against the resilient member 144 to cause the diameter of bore 154 to resiliently decrease and/or to cause the resilient member 144 to resiliently deform and press against the catheter 102 when the catheter 102 is positioned within the bore 154”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Pacak et al. device to incorporate the teachings of Starnes and include the scope abutment apparatus as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to “at least partially secure the relative axial positions of the sheath” and the endoscope or instrument inserted therein (PP [0031]). The modification as proposed would not alter the main operating principle of the Pacak et al. device, which provides a trocar (see T in Fig. 17) comprising a lumen extending therethrough for receiving a secondary instrument or endoscope, but would simply and predictably provide a way to lock the axial position of said instrument or endoscope relative to the trocar support sheath during a surgical procedure.
Regarding claim 2, Pacak et al. as modified by Starnes further discloses wherein the rectal bumper (204 in Fig. 12A of Pacak et al.) includes a collar secured to the guide tube distal end (inner surface of 203 which attaches to the trocar, see Figs. 12 and 17) and a flexible flange (body of balloon 204 is flexible and extends outwardly as a flange) extending radially outward from the collar (the body of 204 extends radially outward from the inner surface of 203, see Figs. 12 and 17).
Regarding claim 3, Pacak et al. as modified by Starnes further discloses wherein the skin bumper (202 in Fig. 12A of Pacak et al.) includes a central hub (205, 206, 207, and 208 in Fig. 17) having a side wall defining an opening (209) through which the guide tube (T) extends, the central hub (205, 206, 207, and 208) having a patient side (208) including a rounded top surface (see Fig. 21, 208 has a rounded surface).
Regarding claim 4, Pacak et al. as modified by Jaspers et al. further discloses wherein the hub (205, 206, 207, and 208 in Fig. 17 of Pacak et al.) has an opposed end (end of 207, see Figs. 20-21) having a generally flat end surface from which a generally elliptical shaped flange (212 and 213 are generally elliptical, see Figs. 20-21) extends, the flange (212 and 213) includes a first portion (212) extending from one side of the hub (205, 206, 207, and 208) and curves toward the guide tube distal end as the first flange portion extends away from the hub (212 extends from the side of 207, which is part of the central hub 205, 206, 207, and 208, and curves at its bottom edge, which is rounded, toward the distal end of the guide tube T, see Fig. 17).
Regarding claim 5, Pacak et al. as modified by Jaspers et al. further discloses wherein the flange includes a second flange portion (213 in Figs. 20-21 of Pacak et al.) extending from the central hub (205, 206, 207, and 208) in a direction opposed to the first flange portion (212, 213 extends in all dimensions since it is a three-dimensional object, and furthermore 213 extends in a direction that does not align with 212, therefore 213 extends in a direction opposed to 212, see Fig. 20), the second flange portion (213) extends outwardly in a generally straight direction (see Fig. 20, 213 extends generally straight along the plane shown in this figure).
Regarding claim 6, Pacak et al. as modified by Starnes further discloses wherein the first and the second flange portions (212 and 213 in Figs. 20-21 of Pacak et al.) have a patient side surface (bottom facing surfaces of 212 and 213 with 300 therebetween) having an inverted V-shaped cross-section (a cross section of 212 and 213 is V-shaped when taken normal to the axis of the guide tube T, see splayed V-shape formed by 212 and 213, see annotated Fig. 20 below), the patient side surface tapers downwardly as the surface extends away from way from a flange centerline (this is broad language, the patient side surface tapers downwardly along the outer surfaces of 212 and 213, see annotated Fig. 21 for the taper of the corner of 213, the edges of flanges 212 and 213 are rounded and can be said to taper downwardly away from a flange centerline).
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Regarding claim 7, Pacak et al. as modified by Starnes further discloses wherein a pad of a resilient material (300 in Figs. 20-21 of Pacak et al.) is adhered to the patient side surface of the flange (212 and 213) to aid in patient comfort and sealing (300 is a pad comprising resilient material which is adhered to a proximal end of the device, 300 can aid in patient comfort and sealing by serving as a proximal protrusion/pad/flange for further anchoring the device in place against the body opening thus enhancing comfort and sealing, see MPEP 2112.01).
Regarding claim 8, Pacak et al. as modified by Starnes further discloses wherein the lock (207 in Fig. 15 of Pacak et al. interacting with T) includes a locking tab (241) slidably received in the central hub (205, 206, 207, and 208, 214 can slide inward relative to the central hub 205, 206, 207, and 208), the locking tab (241) being selectively engageable with the guide tube (PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”, PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”).
Regarding claim 9, Pacak et al. as modified by Starnes further discloses wherein the locking tab (241 in Fig. 15 of Pacak et al.) has an unlocked position wherein the guide tube (T) slides freely within the central hub (205, 206, 207, and 208, PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”) and a locked position wherein the locking tab (241) engages the guide tube (T) restricting movement (PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”).
Regarding claim 10, Pacak et al. as modified by Starnes further discloses wherein the locking tab (241 in Fig. 15 of Pacak et al.) includes a surface (240) defining an opening (255) having a first and second diameter (see Fig. 15, the opening 250 has a plurality of diameters defined by the level of compression of the wedge sections of the clamp 240), the first diameter being larger than the second diameter, the first diameter being larger than an outside diameter of the guide tube (PP [0141]: “The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”).
Regarding claim 11, Pacak et al. as modified by Starnes further discloses wherein the lock (207 in Fig. 15 of Pacak et al. interacting with T) includes a plurality of longitudinally spaced annular grooves (see unmarked grooves on T in Fig. 17) formed on a guide tube outer wall (T), the grooves each having a diameter less than the outside diameter of the guide tube (see unmarked grooves on T in Fig. 17, there are portions with a smaller relative diameter than others, PP [0063]: “the annular expandable member includes a sleeve slightly bigger than the trocar with an internal peripheral rib which engages over a rib on the trocar to lock the annular expandable member in place”, the outside diameter of the guide tube/trocar T includes the ribs, and the grooves have a diameter that is less than the outside diameter), the second diameter of the locking tab (241) being larger than the diameter of the grooves (see Fig. 17, when 241 is clamped the second diameter is larger than the grooves and does not bend or deform the trocar), wherein when the locking tab is moved into a locking position, movement of the guide tube (T) is restricted (PP [0063]: “the annular expandable member includes a sleeve slightly bigger than the trocar with an internal peripheral rib which engages over a rib on the trocar to lock the annular expandable member in place”).
Regarding claim 12, Pacak et al. as modified by Starnes further discloses wherein the central hub side wall (inner side wall of 205, 206, 207, and 208 in Fig. 17 of Pacak et al. defining opening 209) includes a pair of radially opposed slots (side slots defined by 256 which each wing of frame 247 is located in, see Fig. 15) in which the locking tab (241) slides across the central hub opening (209).
Regarding claim 15, Pacak et al. as modified by Starnes further discloses wherein the rectal bumper (204 in Fig. 12A of Pacak et al.) includes an inflatable cuff (204 is an inflatable collar) and the guide tube (T) includes a channel therein in fluid communication with the cuff (204) to provide a fluid connection to a fluid source for inflating and deflating the cuff (see helical duct 215 in Fig. 12A for providing fluid connection to 204).
With respect to claim 24, Pacak et al. discloses an anorectal junction device (see Figs. 12A-21, since the device contains all of the described structures and is configured for insertion into a body opening of a patient for securing instruments inserted therethrough it can be considered an anorectal junction device) comprising:
a guide tube (T in Fig. 12A) having a distal and proximal end defining a lumen there between (see lumen through T, see also Fig. 17), the lumen adapted to receive there through an endoscope (see lumen in Fig. 17, it is adapted to receive an endoscope);
a rectal bumper (204 in Fig. 12A) formed of a resilient material disposed on the guide tube distal end (see Fig. 12A, 204 is on a distal end of T), the rectal bumper (204) adapted to sealing engage rectal tissue when the guide tube (T) is inserted in a patient (PP [0127]: “for engaging the interior of the body of the patient”, since bumper 204 device of Pacak et al. is adapted to engage an opening in a patient it is adapted to sealingly engage rectal tissue since it is a material configured for insertion through a body opening that the anus of a patient can sealingly compress, see MPEP 2112.01);
a skin bumper (202) slidably disposed over the guide tube (T, see Figs. 12A-B, the skin bumper (202) being adapted to engage an intergluteal cleft of the patient (202 is adapted to sit outside of a body opening and is adapted to engage an intergluteal cleft, see MPEP 2112.01), the skin bumper (202) a seal with the patient (202 is configured to seal against a patient because it is adapted to sit outside of a body opening and is made of a rigid material which the anus of a patient can sealingly compress, see MPEP 2112.01); and
a lock including a movable member (241, see also Fig. 15) for selectively locking the position of the skin bumper relative to the guide tube (T, PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”, PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”);
wherein the skin bumper (202 in Fig. 12A) includes a central hub (205, 206, 207, and 208 in Fig. 17) having a side wall defining an opening (209) through which the guide tube (T) extends, the hub (205, 206, 207, and 208) having a patient side (bottom side of 202 that faces the patient when placed within an incision) including a rounded top surface (see Fig. 21, 208 has a rounded surface), wherein the hub (205, 206, 207, and 208) has an opposed end (end of 207, see Figs. 20-21) having a generally flat end surface from which a generally elliptical shaped flange (212 and 213 are generally elliptical, see Figs. 20-21) extends, the flange (212 and 213) includes a flange first portion (212) extending from one side of the hub (205, 206, 207, and 208) and curves toward the guide tube distal end as the flange first portion extends outwardly from the hub (212 extends outwardly from the side of 207, which is part of the central hub 205, 206, 207, and 208, and curves at its bottom edge, which is rounded, toward the distal end of the guide tube T, see Fig. 17), the flange (212 and 213) includes a second flange portion (213 in Figs. 20-21 of Pacak et al.) extending from the hub (205, 206, 207, and 208) in a direction opposed to the flange first portion (212, 213 extends in all dimensions since it is a three-dimensional object, and furthermore 213 extends in a direction that does not align with 212, therefore 213 extends in a direction opposed to 212, see Fig. 20), the flange second portion (213) extends outwardly in a generally straight orientation (see Fig. 20, 213 extends generally straight along the plane shown in this figure), and wherein the first and the second flange portions (212 and 213 in Figs. 20-21) have an inverted V-shaped cross-section (a cross section of 212 and 213 is V-shaped when taken normal to the axis of the guide tube T, see splayed V-shape formed by 212 and 213, see annotated Fig. 20 below) forming at least a portion of the patient side of the skin bumper (212 and 213 form a cross-section which faces the patient on skin bumper 202), wherein the patient side surface tapers downwardly as the surface extends away from way from a flange centerline (the patient side tapers downwardly along the outer surfaces of 212 and 213, see annotated Fig. 21 for the taper of the corner of 213, the edges of flanges 212 and 213 are rounded and can be said to taper downwardly away from a flange centerline).
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However, Pacak et al. fails to disclose a scope abutment apparatus disposed on the proximal end of the guide tube, the scope abutment apparatus adapted to selectively engage the endoscope and form a seal therewith.
In the related filed of occlusion catheter systems (abstract), which is related due to its concern with guiding and deploying shafted surgical tools within a body lumen, Starnes teaches a guide tube (124 of 100 in Fig. 1) comprising a scope abutment apparatus (114, 142, and 140, see also Fig. 4) disposed on the proximal end of the guide tube (124 in Fig. 1), the scope abutment apparatus (114, 142, and 140 in Fig. 4) adapted to selectively engage an endoscope and for a seal therewith (PP [0025]: “A portion of the force from the seat portion 148 can act inwardly against the resilient member 144 to cause the diameter of bore 154 to resiliently decrease and/or to cause the resilient member 144 to resiliently deform and press against the catheter 102 when the catheter 102 is positioned within the bore 154”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Pacak et al. device to incorporate the teachings of Starnes and include the scope abutment apparatus as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to “at least partially secure the relative axial positions of the sheath” and the endoscope or instrument inserted therein (PP [0031]). The modification as proposed would not alter the main operating principle of the Pacak et al. device, which provides a trocar (see T in Fig. 17) comprising a lumen extending therethrough for receiving a secondary instrument or endoscope, but would simply and predictably provide a way to lock the axial position of said instrument or endoscope relative to the trocar support sheath during a surgical procedure.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US PGPub 2020/0060719 A1) in view of Starnes (US PGPub 2015/0201944 A1), as applied to claim 1 above, and further in view of Piskun et al. (US PGPub 2008/0255519 A1).
Regarding claim 16, Pacak et al. as modified by Starnes fails to disclose a flexible sheath disposed within the guide tube and extending outwardly over the rectal bumper, the sheath retaining the rectal bumper in an insertion position and wherein removal of the sheath releases the rectal bumper to permit expansion of the rectal bumper.
In the same field of surgical access ports, Piskun et al. teaches a guide tube (see Figs. 2-3) and a flexible sheath (18, see PP [0101], the skirt is elastomeric and flexible) disposed within the guide tube (PP [0030]: “The skirt member is at least partially flexible and is attached to the body on the inner side thereof”) and configured to extend outwardly over a distal end of the guide tube (since skirt 18 is flexible, it is configured to invert to cover the distal end of the guide tube).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Pacak et al. and Starnes to further incorporate the teachings of Piskun et al. and include the flexible sheath as taught such that the sheath retains the rectal bumper in an insertion position and wherein removal of the sheath releases the rectal bumper to permit expansion of the rectal bumper in order to “a protective barrier between laparoscopic instrument shafts (as well as their operative tips) and… wall tissues” (PP [0148], although this section refers to an alternate skirt embodiment it is still relevant to the embodiment of Figs. 2-3). Although the device of Piskun et al. is intended for deployment in an abdominal wall, it has separate utility in other various laparoscopic procedures (PP [0012]). Since the Piskun et al. reference shares a common goal with the alternate guide sheath devices of Pacak et al. and Jaspers et al., of retaining a shaft within a surgical opening of a patient, combining these devices as proposed would constitute applying a known technique (the use of a flexible sheath as taught by Piskun et al.) to improve a similar device (the combination as proposed) in the same way, since adding the flexible sheath of Piskun et al. would add protection to the patient’s internal tissue, including rectal tissue.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US PGPub 2020/0060719 A1) in view of Starnes (US PGPub 2015/0201944 A1), as applied to claim 1 above, and further in view of Mueller et al. (US Patent No. 5,766,163).
Regarding claim 17, Pacak et al. as modified by Starnes fails to disclose wherein the guide tube includes a first longitudinal portion and second longitudinal portion, the first and second longitudinal portions being selectively joined and separated.
In the same field of guide tubes for minimally invasive procedures (abstract), Mueller et al. teaches a guide tube (see Fig. 3) wherein the guide tube includes a first longitudinal portion (400) and second longitudinal portion (408), the first and second longitudinal portions being selectively joined and separated (col. 7, lines 28-29: “FIG. 3 is a representative view of a two-piece trocar apparatus of the present invention”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Pacak et al. and Jaspers et al. combination according to the teachings of Mueller et al. and included wherein the guide tube includes a first longitudinal portion and second longitudinal portion, the first and second longitudinal portions being selectively joined and separated. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the two-piece trocar as taught by Mueller et al.) to improve a similar device (the guide tube of the combination as Pacak et al. and Jaspers et al. as proposed) in the same way. One of ordinary skill in the art would have yielded predictable results, since it has been held that constructing a formerly integral structure in separable elements involves only routine skill in the art (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)).
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.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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