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 .
Formal Matters
Applicant’s Response and Amendments filed 9 February 2026 are acknowledged. Claims 2, 12-15, and 17 are cancelled. Claims 1, 4, and 22-26 are currently amended. Claims 1, 3-11, 16, and 18-26 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 22-26 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn in light of Applicant’s amendments.
The rejection of claims 1, 3, and 21 under 35 U.S.C. 103 as being unpatentable over Peine US 20200121405 (23 April 2020), in view of Cully et al., US 20120095485 (19 April 2012), is withdrawn in light of Applicant’s arguments and amendments. However, new rejections are set forth below.
The rejection of claims 4-6, 16, 18, 22, 23, 25, and 26 under 35 U.S.C. 103 as being unpatentable over Peine US 20200121405 (23 April 2020) in view of Draper et al., US 20180289431 (11 October 2018), is withdrawn in light of Applicant’s arguments and amendments. However, new rejections are set forth below.
Claims 19 and 20 under 35 U.S.C. 103 as being unpatentable over Peine US 20200121405 (23 April 2020) in view of Draper et al., US 20180289431 (11 October 2018) and further in view of Clark et al., US 20220233820 (28 July 2022, benefit to 15 July 2019), is withdrawn in light of Applicant’s arguments and amendments. However, new rejections are set forth below.
The rejection of claims 7 and 24 under 35 U.S.C. 103 as being unpatentable over Peine US 20200121405 (23 April 2020), in view of Cully et al., US 20120095485 (19 April 2012) and further in view of Draper et al., US 20180289431 (11 October 2018), is withdrawn in light of Applicant’s arguments and amendments. However, new rejections are set forth below.
The rejection of claims 8-11 under 35 U.S.C. 103 as being unpatentable over Peine US 20200121405 (23 April 2020) in view of Cully et al., US 20120095485 (19 April 2012) and further in view and Shah, US 20180289394 (11 October 2018), is withdrawn in light of Applicant’s amendments. However, new rejections are set forth below.
Response to Arguments
Applicant’s arguments have been fully considered and they are persuasive. However, some of Applicant’s amendments to the claims required new rejections, necessitated by amendment. Additionally, further search and consideration of the prior art and the amended claims revealed relevant prior art that reads on the claims, as written. Accordingly, this Office Action is non-final.
Applicant’s arguments directed to FIGs 10 and 12 of the Application (Remarks, numbered p. 8) are noted. However, Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims must stand on their own. Merrill v. Yeomans, 94 US 568, 570 (1876) and In re Hiniker, 150 F.3d 1362, 1369 (Fed. Cir. 1998). The claims are written much more broadly and encompass many more embodiments than the subject matter of FIGs 10 and 12.
New and Modified Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 24 recites “an elongate rod includes a closed, blunt distal end” in line 2. An “elongate rode having a blunt distal end” was previously found in original claim 2 and in the original specification as filed. However, none of the original claims, originally filed specification, nor the drawings textually or visually provide originally filed support for the added limitation that the distal end be “closed.” Accordingly the claim contains new matter.
The rejection was made in the last Office Action, but a typographical error inadvertently identified claim 21 as containing the limitation “closed” in the statement of the rejection when claim 24 was the claim at issue. Accordingly, this Office Action is non-final.
Claim Rejections - 35 USC § 112(b)
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, 3-11 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.
Independent claim 1 has been amended to recite that the elongate rod (line 2) has “rounded corners” (line 3). The base structure appears to be a circle in cross-section as it is recited as a “rod” in line 2. Circular objects don’t typically have “corners”. The specification at ¶143 recites “[t]he atraumatic/blunt tip 87 may include an at least partially flat axial face 88 and/or rounded corner/edge portion(s) to provide the blunt form that is less potentially damaging to tissue at the treatment site than the distal end of the percutaneous-access device 200 alone.” Rounded “edge portions” would be more applicable to a base rod-structure. However, it is unclear whether the rod is to be circular to obviate corners or whether some other rod-like shape is intended. Clarification is required.
Claims 3-11 and 21 are rejected as depending from a rejected claim.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dreyer et al., US 20190231175 (1 August 2019).
Regarding amended claim 1, Dreyer teaches an alignment device (FIGs 1, 3, imaging sleeve 100) comprising:
an elongate rod (102) having a blunt (FIG 5, FIG 1, cap 600; ¶36) distal end (106, ¶31) that included an at least partially flat axial face (FIG 5, cap 600, transparent window 612, ¶36) and rounded corners (FIG 5, cap 600, engagement lid 610);
a sealing hub (engagement mechanism 202, ¶33) coupled to a proximal end of the elongate rod (102; ¶36) and configured to form a fluid-tight seal within a portion of a percutaneous-access device (¶25); and
an alignment structure (FIG 1, engagement member 120; ¶¶31, 32) coupled to the sealing hub (FIG 1, 202; ¶33) and having a form configured to engage with a component (FIG 1, 100) of an instrument manipulator assembly of a robotic system (FIG 1, imaging device 500, ¶27).
Regarding claim 3, Dreyer teaches the alignment device of claim 1, as set forth above, wherein a distal end (106) of the elongate rod (102) includes a flat axial face portion (cap 600; ¶36).
Claims 16, 18, 22, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Draper et al., US 20180289431 (11 October 2018) (previously cited of record).
Regarding independent claim 16, Draper teaches a robotic system (FIG 1C, surgical robotic system, 110, ¶24) comprising:
a robotic arm (FIG 1C, robotic arm 175; ¶30);
an instrument manipulator assembly (FIGs 5A-D, instrument manipulator assembly 190) associated with a distal portion of the robotic arm (FIG 3B);
a percutaneous-access device (patient introducer 301, ¶42) comprising an elongate shaft forming an access lumen (introducer tube 307, ¶43); and
an alignment device (FIG 3A) including an elongate rod (surgical tool/endoscope 115, ¶¶42, 44) configured to be disposed at least partially within the access lumen (introducer tube 307; ¶44) and a proximal alignment member (309; ¶52) having a form configured to engage with an outer surface of the instrument manipulator assembly (FIGs 5A-D, IDM 190, ¶52),
wherein the instrument manipulator assembly (190) includes an adapter component (FIGs 4A-B, 5C-D), the outer surface being associated with a rotating plate (first curved surface 311, ¶52) of the adapter component (FIGs 4A-B, 5C-D).
Regarding claim 18, Draper teaches the robotic system of claim 16, as set forth above, wherein the adapter component (FIGs 4A-B, 5 C-D), is coupled to a drape (sterile adapter, ¶59) that is configured to provide a sterile barrier between the robotic arm and an instrument of the instrument manipulator assembly that is coupled to the adapter component (190; ¶59).
Regarding amended claim 22, Draper teaches the robotic system of claim 16, as set forth above.
Draper teaches wherein the instrument manipulator assembly comprises a plurality of rotary drivers (FIG 3B, 6 degrees of freedom of rotation around X, Y, Z axis, IDM 190; ¶48).
Regarding amended claim 23, Draper teaches the robotic system of claim 16, as set forth above, wherein the elongate shaft of the percutaneous access device (introducer tube 307, ¶43) is an outer shaft (FIG 3A) and the percutaneous access device further comprises an inner shaft (FIGs 1A, C, “endoscope 115 comprising a working channel for insertion of other medical instruments, imaging devices” ¶26; and steerable catheter 145, ¶27) configured to be disposed at least partially within the access lumen of the outer shaft (¶43).
Regarding amended claim 25, Draper teaches the robotic system of claim 16, as set forth above, wherein the proximal alignment member (309; ¶52) has a concave proximal surface (FIGs 5A-D, alignment member includes a first curved surface 311 and elongated protrusion 313; ¶52) conforming to the outer surface of the instrument manipulator assembly (FIGs 5A-D, IDM 190, ¶52).
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.
Claims 4-7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over by Dreyer et al., US 20190231175 (1 August 2019) in view of Draper et al., US 20180289431 (11 October 2018) (previously cited of record).
Regarding amended claim 4, Dreyer teaches the alignment device of claim 1, as set forth above.
Dreyer does not teach wherein the alignment structure has a concave proximal surface conforming to an outer surface of the instrument manipulator assembly.
Draper teaches an alignment member (FIG 3A, alignment member 309) for a surgical robotic system (FIG 1C, robotic arm 175; ¶30) wherein the alignment structure (FIGs 5A-D; ¶52) has a concave proximal surface (FIGs 5A-D, alignment member includes a first curved surface 311 and elongated protrusion 313; ¶52) conforming to an outer surface of the instrument manipulator assembly (FIGs 5A-D, IDM 190, ¶52).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Draper, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Draper teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Dreyer does not disclose that the alignment structure has a concave proximal surface conforming to an outer surface of the instrument manipulator assembly.
Draper specifically addresses an alignment member 309 to engage with a component of an instrument manipulator assembly 190 where the alignment structure has a concave proximal surface (FIGs 5A-D; ¶52) conforming to an outer surface of the instrument manipulator assembly 190 (FIGs 5A-D). Draper teaches alignment members that include a curved surface as a complementary shape to an external surface of the instrument device manipulator 190 (FIGs 5A-D; ¶52). Draper shows an alignment member 309 comprising a concave proximal surface 311 attached to 190. Draper explains that the manipulator assemblies and alignment members may include complementary shapes and alignment markings thereon in order to facilitate rotational alignment of the alignment member and the manipulator assembly (¶5). Because Dreyer includes that the alignment structure has a form configured to engage with a component of an instrument manipulator assembly of a robotic system, a person of ordinary skill in the art, seeking to utilize known alignment devices linked to robotic systems would reasonably consult Draper’s alignment device solution in order to avoid creating a new and untested robotic architecture. Draper’s alignment member engages with a component of an instrument manipulator system with a complementary surface that can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly of a robotic system) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 5, Dreyer modified by Draper teaches the alignment device of claim 4, as set forth above, for the reasons set forth above.
Draper teaches wherein the alignment structure (FIGs 5A-D; ¶52) has a vertical-alignment lip (elongated protrusion 313; ¶52) that is inwardly-projecting and circumferential with respect to a curvature of the concave proximal surface (FIGs 5C, 5D).
Regarding claim 6, Dreyer modified by Draper teaches the alignment device of claim 5, as set forth above, for the reasons set forth above.
Draper teaches wherein the vertical-alignment lip (elongated protrusion 313; ¶52) is configured to be placed against at least one of an upward-facing surface or a downward-facing surface of the component of the instrument manipulator assembly when the concave proximal surface is placed against the outer surface of the instrument manipulator assembly (FIGs 5C, 5D).
Regarding claim 7, Dreyer modified by Draper teaches the alignment device of claim 1, as set forth above, for the reasons set forth above.
Draper teaches wherein the alignment structure (FIGs 5A-D; ¶52) includes one or more alignment markings (FIGs 5A-D) indicating an alignment position of the alignment structure relative to at least one component of the instrument manipulator assembly (¶47).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Draper, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Draper teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Dreyer does not disclose that the alignment structure has a concave proximal surface conforming to an outer surface of the instrument manipulator assembly.
Draper specifically addresses an alignment member 309 to engage with a component of an instrument manipulator assembly 190 where the alignment structure has a concave proximal surface (FIGs 4A-B, 5C-D, 309; ¶52) conforming to an outer surface of the instrument manipulator assembly 190 (FIGs 5A-D). Draper teaches alignment members that include a curved surface as a complementary shape to an external surface of the instrument device manipulator 190 (FIGs 5A-D; ¶52). Draper shows an alignment member 309 comprising a concave proximal surface 311 attached to 190. Draper explains that the manipulator assemblies and alignment members may include complementary shapes and alignment markings thereon in order to facilitate rotational alignment of the alignment member and the manipulator assembly (¶5).
Because Dreyer includes that the alignment structure has a form configured to engage with a component of an instrument manipulator assembly of a robotic system, a person of ordinary skill in the art, seeking to utilize known alignment devices linked to robotic systems would reasonably consult Draper’s alignment device solution in order to avoid creating a new and untested robotic architecture. Drapers alignment member engages with a component of an instrument manipulator system with a complementary surface that can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly of a robotic system) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding amended claim 24, Draper teaches the robotic system of claim 16, as set forth above.
Draper does not expressly teach wherein the elongate rod includes a closed, blunt distal end extendable from an open distal end of the elongate shaft.
Dreyer teaches an alignment device (FIG 1) wherein the elongate rod (102) includes a closed (FIG 5, cap 600, engagement lid 610, “multi-lumen cap to selectively seal one or more lumens”; ¶36), blunt (FIG 5, FIG 1, cap 600; ¶36) distal end (106, ¶31) extendable from an open distal end of the elongate shaft (¶6).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Draper and Dreyer, given that the prior art included each element claimed, although not necessarily in a single reference. Draper and Dreyer teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Draper discloses the claimed base robotic system (robotic arm, instrument manipulator assembly, percutaneous access device, elongate rod, alignment member), Draper does not disclose wherein the elongate rod includes a closed, blunt distal end extendable from an open distal end of the elongate shaft.
Dreyer specifically addresses system comprising an alignment device (FIG 1) wherein the elongate rod 102 includes a closed (FIG 5, cap 600, engagement lid 610, “multi-lumen cap to selectively seal one or more lumens”; ¶36), blunt (FIG 5, FIG 1, cap 600; ¶36) distal end (106, ¶31) extendable from an open distal end of the elongate shaft (¶6). Because Dreyer includes an alignment device configured to engage with a component of an instrument manipulator assembly of a robotic system and facilitates multi-lumen selectively closed distal end, a person of ordinary skill in the art, seeking to utilize known alignment devices linked to robotic systems would reasonably consult Dreyer’s alignment device closed-end solution in order to avoid creating novel device architecture. Dreyer’s alignment member engages with components of a robotic instrument manipulator system and permits selective alignment comprising closed (capped) distal lumen using known assembly methods and could be used without redesigning Drapers elongate device distal structure.
Because the references address the same engineering problem (utilizing a distal end structure of an elongate rod in a surgical instrumentation system for percutaneous access devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component (cap) with a complementary shape that aligns the alignment device and closes (caps) the distal end of the elongate rod), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Draper et al., US 20180289431 (11 October 2018), in view of Shah, US 20180289394 (11 October 2018) (both previously cited of record).
Regarding claim 20, Draper teaches the robotic system of claim 16, as set forth above.
Draper does not teach wherein the alignment device includes a hub member secured to a proximal end of the elongate rod.
Shah teaches an alignment device (FIG 1, sheath assembly) includes a hub member secured to a proximal end of the elongate rod (FIGs 2e, 4).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Draper and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Draper and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Draper discloses the claimed base robotic system (elongate rod, sealing hub, alignment structure), Draper does not expressly teach wherein the alignment device includes a hub member secured to a proximal end of the elongate rod.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). SFIG 2f is of Shah is a dilator/obturator used in the sheath assembly (¶63). Because Shah includes an alignment structure that has a form configured to engage with a component of an instrument manipulator assembly (FIG 1), a person of ordinary skill in the art, seeking to utilize known alignment devices would reasonably consult Shah’s threaded sealing hub solution in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub engages with a component of an instrument manipulator system with a complementary surface that can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding amended claim 26, Draper teaches the robotic system of claim 16, as set forth above.
Draper does not expressly teach wherein the alignment device further includes a sealing hub coupled to a proximal end of the elongate rod and defining a cavity, and wherein the proximal alignment member provides a connector receivable in the cavity.
Shah teaches wherein the alignment device (FIG 1, sheath assembly) further includes a sealing hub (FIG 2e) coupled to a proximal end of the elongate rod (FIGs 2a-c, 4) and defining defines a cavity (FIGs 2e, 4) and wherein the proximal alignment member provides a connector receivable in the cavity (thread 6 configured to couple screw mechanism 7 to the sealing hub; FIGs 2a-e, 4; ¶77).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Draper and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Draper and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Draper discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Draper does not expressly teach wherein the alignment device further includes a sealing hub coupled to a proximal end of the elongate rod and defining a cavity, and wherein the proximal alignment member provides a connector receivable in the cavity.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). Shah specifically discloses an alignment device (FIG 1, sheath assembly) further including a sealing hub (FIG 2e) coupled to a proximal end of the elongate rod (FIGs 2a-c, 4) and defining defines a cavity (FIGs 2e, 4) and wherein the proximal alignment member provides a connector receivable in the cavity (thread 6 configured to couple screw mechanism 7 to the sealing hub; FIGs 2a-e, 4; ¶77). Because Shah includes an alignment device further includes a sealing hub coupled to a proximal end of the elongate rod and defining a cavity, and wherein the proximal alignment member provides a connector receivable in the cavity, a person of ordinary skill in the art, seeking to utilize known alignment device connective structures would reasonably consult Shah’s sealing hub solution in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub and connector solution can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 8-11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Dreyer et al., US 20190231175 (1 August 2019), as set forth above, in view of Shah, US 20180289394 (11 October 2018) (previous cited of record).
Regarding claim 8, Dreyer teaches the alignment device of claim 1, as set forth above, for the reasons set forth above.
Dreyer does not expressly teach wherein the sealing hub has external threading configured to engage with internal threading of the percutaneous access device.
Shah teaches an alignment device (FIG 1, sheath assembly) wherein the sealing hub has external threading (FIG 2e, screw mechanism 7; ¶80) configured to engage with internal threading (FIG 2d, thread mechanism 6; ¶80) of the percutaneous access device (FIGs 2a-e, 4; ¶28).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Dreyer does not expressly teach wherein the sealing hub has external threading configured to engage with internal threading of the percutaneous access device.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). Shah specifically addresses threaded sealing hubs useful for irrigation and suction useful in surgeries (¶21). FIG 2f is of Shah is a dilator/obturator used in the sheath assembly (¶63). Because Shah includes an alignment structure that has a form configured to engage with a component of an instrument manipulator assembly (FIG 1), a person of ordinary skill in the art, seeking to utilize known alignment devices would reasonably consult Shah’s threaded sealing hub solution in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub engages with a component of an instrument manipulator system with a complementary surface that can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 9, Dreyer teaches the alignment device of claim 1, as set forth above.
Dreyer does not expressly teach wherein the alignment structure is configured to be attached to the sealing hub from a state separate from the sealing hub.
Shah teaches an alignment device (FIG 1, sheath assembly) including a hub member (FIG 2e) secured to a proximal end of the elongate rod (FIGs 2a-e, 4) wherein the alignment structure (sheath assembly) is configured to be attached to the sealing hub from a state separate from the sealing hub (FIGs 2a-e, 4).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Dreyer does not expressly teach wherein the alignment structure is configured to be attached to the sealing hub from a state separate from the sealing hub.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). Shah teaches an alignment device (FIG 1, sheath assembly) including a hub member (FIG 2e) secured to a proximal end of the elongate rod (FIGs 2a-e, 4) wherein the alignment structure (sheath assembly) is configured to be attached to the sealing hub from a state separate from the sealing hub (FIGs 2a-e, 4). Because Shah includes an alignment structure that has a form configured to engage with a component of an instrument manipulator assembly (FIGs 2a-e, 4), a person of ordinary skill in the art, seeking to utilize known alignment devices would reasonably consult Shah’s sealing hub solution in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub engages the alignment structure from a state separate from the sealing hub, which can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 10, Dreyer modified by Shah teaches the alignment device of claim 9, as set forth above, for the reasons set forth above.
Shah teaches wherein the alignment structure (FIG 1, sheath assembly) comprises a distally-projecting male connector (screw mechanism 7) configured to be coupled (thread 6) to the sealing hub (FIG 2e, ¶77).
Regarding claim 11, Dreyer teaches the alignment device of claim 1, as set forth above, for the reasons set forth above.
Dreyer does not expressly teach wherein the alignment structure is axially rotatable relative to the sealing hub.
Shah teaches wherein the alignment structure (FIG 1, sheath assembly) is axially rotatable relative to the sealing hub (thread 6 configured to couple screw mechanism 7 to the sealing hub; FIG 2, 2e; ¶77).
The phrase “axially rotatable relative to the sealing hub” is interpreted in the broadest reasonable interpretation based on the disclosures in the specification. At ¶8, the specification does not expressly define “axially rotatable” but provides an example where “the alignment structure comprises a distally-projecting male connector configured to be coupled to the sealing hub. The alignment structure can be axially rotatable relative to the sealing hub.” Accordingly, the thread/screw mechanism of Shah is broadly interpreted as “axially rotatable” relative to the sealing hub.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure). Dreyer does not disclose wherein the alignment structure is axially rotatable relative to the sealing hub.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). Shah specifically addresses wherein the alignment structure is axially rotatable relative to the sealing hub (thread 6 configured to couple screw mechanism 7 to the sealing hub; FIG 2, 2e; ¶77). Because Shah includes an alignment structure that has a form configured to engage with a component of an instrument manipulator assembly (FIG 1), a person of ordinary skill in the art, seeking to utilize known alignment devices would reasonably consult Shah’s threaded sealing hub solution in order to axially rotate the alignment structure relative to the sealing hub in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub engages with a component of an instrument manipulator system with a complementary surface that can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 21, Dreyer teaches the alignment device of claim 1, as set forth above.
Dreyer does not teach wherein the sealing hub defines a cavity and the alignment structure provides a connector receivable in the cavity.
Shah teaches wherein the sealing hub (FIG 2e) defines a cavity (FIGs 2e, 4) and the alignment structure (FIG 1, sheath assembly) provides a connector receivable in the cavity (thread 6 configured to couple screw mechanism 7 to the sealing hub; FIG 2, 2e; ¶77).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Dreyer and Shah, given that the prior art included each element claimed, although not necessarily in a single reference. Dreyer and Shah teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Dreyer discloses the claimed base alignment device (elongate rod, sealing hub, alignment structure), Dreyer does not expressly teach wherein the alignment structure is configured to be attached to the sealing hub from a state separate from the sealing hub.
Shah’s sheath assembly (FIG 1) and multi-hole catheter device (FIG 3a-b) are taught as being useful for different types of surgery involving suction, irrigation, and material removal (Abstract). Shah teaches an alignment device (FIG 1, sheath assembly) including a hub member (FIG 2e) secured to a proximal end of the elongate rod (FIGs 2a-e, 4) wherein the alignment structure (sheath assembly) is configured to be attached to the sealing hub from a state separate from the sealing hub (FIGs 2a-e, 4). Because Shah includes an alignment structure that has a form configured to engage with a component of an instrument manipulator assembly (FIGs 2a-e, 4), a person of ordinary skill in the art, seeking to utilize known alignment devices would reasonably consult Shah’s sealing hub solution in order to avoid creating a new and untested structural architecture. Shah’s threaded sealing hub engages the alignment structure from a state separate from the sealing hub, which can be incorporated alongside Dreyer’s alignment device (elongate rod, sealing hub, and alignment structure coupled to the sealing hub and having a form configured to engage with a components of an instrument manipulator assembly) using known assembly methods without redesigning Dreyer’s core device structure.
Because the references address the same engineering problem (coordinating the structure of an alignment member with an instrument manipulator assembly) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an structural component that with a complementary shape that aligns the alignment device with a robotic instrument manipulator assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Draper et al., US 20180289431 (11 October 2018), as set forth above, in view of Clark et al., US 20220233820 (28 July 2022, benefit to 15 July 2019) (both previously cited of record).
Regarding claim 19, Draper teaches the robotic system of claim 16, as set forth above.
Draper teaches the system further comprising a catheter assembly (steerable catheter 145, ¶27).
Draper does not expressly teach that the catheter is coupled to a catheter handle configured to be attached to the adapter component.
Clark teaches catheter assemblies comprising catheters coupled to a catheter handle configured to be attached to adapter components ¶79. Clark teaches apparatus for supporting and driving elongated medical devices in a robotic catheter-based procedure system (Abstract).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Draper and Clark, given that the prior art included each element claimed, although not necessarily in a single reference. Draper and Clark teach in the same field of endeavor, surgical robotic systems for guiding surgical tools through luminal networks.
Although, Draper discloses the claimed base robotic system (elongate rod, sealing hub, alignment structure), Draper does not expressly teach that the catheter is coupled to a catheter handle configured to be attached to the adapter component.
Clark teaches robotic based catheter-based procedure system comprising catheter assemblies comprising catheters coupled to a catheter handle configured to be attached to adapter components ¶79. Clark teaches apparatus for supporting and driving elongated medical devices in a robotic catheter-based procedure system (Abstract). Because Clark includes a catheter assembly system comprising an elongated medical device (EMD) handle mechanism that is operatively controlled robotically (¶79) to manipulate features within the catheter such as wires that extend from the handle to the distal end of the catheter to deflect the distal end of the catheter (¶79), a person of ordinary skill in the art, seeking to utilize known robotically controlled catheter devices would reasonably consult Clark’s EMD solution in order to avoid creating a new and untested robotic control components for elongate medical devices. Clark’s EMD catheter handle solution can be incorporated alongside Draper’s steerable catheter assembly using known assembly methods without redesigning Draper’s core device structure.
Because the references address the same engineering problem (robotic control of system components, including catheters) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an EMD handled catheter assembly to the robotic system comprising a steerable catheter), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed. This Office Action is NON-FINAL.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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