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
The amendment filed on 1/23/2026 has been entered. Claims 1-4, 6-7, 9-12, and 15-24 remain pending in the application. Applicant’s amendments to the Drawings, Specification, and Claims have overcome each and every objection and 112 rejection previously set forth in the Non-Final Office Action mailed 10/23/2025.
Response to Arguments
Applicant’s arguments, see pages 23-25, filed 1/23/2026, with respect to the rejection under 35 USC § 102 of Claim 9, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejections identified in the Non-Final Office Action dated 10/23/2025 moot, and require a new ground of rejection.
Therefore, the 102 rejections previously identified in the non-final action dated 10/23/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 25-26, filed 1/23/2026, with respect to the rejection under 35 USC § 103 of Claim 1, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejections identified in the Non-Final Office Action dated 10/23/2025 moot, and require a new ground of rejection.
Therefore, the 103 rejections previously identified in the non-final action dated 10/23/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 26-27, filed 1/23/2026, with respect to the rejection under 35 USC § 103 of Claim 15, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejections identified in the Non-Final Office Action dated 10/23/2025 moot, and require a new ground of rejection.
Therefore, the 103 rejections previously identified in the non-final action dated 10/23/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is:
“a steerable section that is configured to be actuated to form a bend” in claims 1 and 15 as described in Para. [0076] and [0084] of Applicant’s specification. The claim interpretation is made in light of the claim objection above.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 4, 6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2024/0138913 A1 to Carlson et al. (“Carlson”) in view of U.S. Patent No. 11,344,188 B1 to Wei et al. (“Wei”).
Regarding claim 1, Carlson discloses a device for performing endoscopic surgery within a patient (aspects of this disclosure may be used in performing an endoscopic, hysteroscope, or ureteroscopic procedure; Fig. 1, paragraph 0023 and 0026) comprising:
a flexible sheath including a lumen (sheath 102 may be generally tubular, for example, including … a lumen 102C extending from proximal end 102A to a distal end 102B; Fig. 1, paragraph 0026), a tip (sheath 102 may be generally tubular, for example, including a distal end 102B; Fig. 1, paragraph 0026), and a flexible section that is configured to be actuated to form a bend, such that the tip is operable to be steered toward an anatomical region within the patient (sheath 102 may be formed of a flexible material, for example, such that sheath 102 may be manipulated and/or delivered to one or more lumens within the subject, for example, to a kidney; Fig. 1, paragraph 0027);
a flexible tube (medical device 104 includes a shaft 108; Fig. 1, paragraph 0026) including an end (a distal tip 122 of shaft 108; Fig. 1, paragraph 0028);
a light source disposed on the end (distal tip 322 of shaft 308 may include one or more illumination devices 330; Fig. 3A, paragraph 0042); and
an image sensor disposed on the end (distal tip 332 of shaft 308 may include … one or more imaging devices 332; Fig. 3A, paragraph 0042),
wherein the flexible tube is configured to be inserted within the lumen and the passage, such that the light source and the image sensor are positioned at the tip (a shaft 308 may be positioned within (e.g. radially within) a sheath 302, and a distal tip 322 of shaft 308 may extend distally beyond a distal end 302B of sheath 302; Fig. 3A, paragraph 0042; the shaft 308 is capable of being disposed at the distal end 302B of sheath 302), and the end is positioned concentrically within an inner diameter of the flexible sheath (the distal tip 322 of the shaft 308 is positioned concentrically within the inner diameter of the sheath 302; Fig. 3A), and
wherein the flexible tube is configured to be removed from the lumen (shaft 308 may be removed proximally from sheath 302; Fig. 3A, paragraph 0043), such that the lumen is operable to aspirate a bodily object from the anatomical region via the tip (as discussed above, suction may be applied to the treatment site through sheath 302, for example, through lumen 302C, Fig. 3B, paragraph 0043).
However, Carlson does not explicitly disclose a handle including a passage and a steerable sheath disposed on the handle, and a steerable section that is configured to be actuated to form a bend, and wherein the flexible tube is configured to be inserted within the lumen and the passage.
Wei teaches a device for performing endoscopic surgery within a patient (an actively bendable sheath 10 of the invention is used for delivering a medical instrument (not shown) therethrough. Examples of the medical instrument include, but are not limited to, an endoscope; Fig. 1 and 11, col. 4, paragraph 5) comprising:
a handle including a passage (handle 24 may provide access into sheath lumen 14; Fig. 10A, col. 6, paragraph 3);
a steerable sheath disposed on the handle and including a lumen (a sheath lumen 14 is defined by a tubular wall 15 longitudinally extending from the proximal sheath end 11 to the distal sheath end 13; Fig. 6, col. 4, paragraph 6), a tip (sheath 10 includes … a distal sheath end 13; Fig. 1, col. 4, paragraph 6), and a steerable section that is configured to be actuated to form a bend, such that the tip is operable to be steered toward an anatomical region within the patient (the tubular wall 15 comprises a deflectable or bendable segment 16 at or adjacent to the distal sheath end 13; Fig. 6, col. 4, paragraph 6);
and wherein a flexible tube is configured to be inserted within the lumen and the passage (at least a part of the medical instrument 20 is configured to pass through the sheath 10 or sheath lumen 14; Fig. 11, col. 7, paragraph 4).
Wei is considered to be analogous to the claimed invention because it is the same field of a steerable sheath with a flexible tube inserted into it. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the sheath of Carlson to incorporate the teachings of Wei by adding a handle to the sheath and constructing the sheath to be configured to be actuated. Doing so increases the functionality of the sheath of Carlson by allowing the user to steer the sheath independently of the flexible tube, as is standard in the art.
Regarding claim 4, Carlson, as previously modified by Wei, discloses the device according to claim 1. Carlson further discloses wherein when the flexible tube is removed from the lumen, the lumen is further operable to deliver a first one or more tools to the anatomical region and irrigate the anatomical region (shaft 308 may be removed proximally from sheath 302. Additionally, an irrigation device 306 may be delivered through lumen 302C of sheath 302 … Irrigation fluid may be delivered through irrigation device 306 and out of the distal opening 306D of irrigation lumen; Fig. 3B, paragraph 0043).
Regarding claim 6, Carlson, as previously modified by Wei, discloses the device according to claim 1. Carlson, as modified by Wei, further discloses wherein the handle further includes an aspiration port in communication with the lumen and an external vacuum device, such that the lumen is operable to aspirate a bodily object from the tip to the aspiration port (although not shown, proximal end 102A of sheath 102 may be coupled to … a suction source (e.g. a suction pump or wall-mounted suction sources) … moreover, although not shown, proximal end 102A of sheath 102 may include one or more valves, ports, etc; Fig. 1, paragraph 0027).
Regarding claim 9, Carlson discloses a method for performing endoscopic surgery (aspects of this disclosure may be used in performing an endoscopic, hysteroscope, or ureteroscopic procedure; Fig. 1, paragraph 0023 and 0026) comprising:
providing a flexible sheath including a flexible section (sheath 102 may be formed of a flexible material, for example, such that sheath 102 may be manipulated and/or delivered to one or more lumens within the subject, for example, to a kidney; Fig. 1, paragraph 0027), a lumen (sheath 102 may be generally tubular, for example, including … a lumen 102C extending from proximal end 102A to a distal end 102B; Fig. 1, paragraph 0026), a tip (sheath 102 may be generally tubular, for example, including a distal end 102B; Fig. 1, paragraph 0026), and a tip (sheath 102 may be generally tubular, for example, including a distal end 102B; Fig. 1, paragraph 0026);
providing a flexible tube (medical device 104 includes a shaft 108; Fig. 1, paragraph 0026) including an end (a distal tip 122 of shaft 108; Fig. 1, paragraph 0028);
providing a light source and an image sensor each disposed on the end (distal tip 322 of shaft 308 may include one or more illumination devices 330, one or more imaging devices 332; Fig. 3A, paragraph 0042);
advancing the flexible tube along an axis of the lumen, such that the light source and the image sensor are positioned at the tip (a shaft 308 may be positioned within (e.g. radially within) a sheath 302, and a distal tip 322 of shaft 308 may extend distally beyond a distal end 302B of sheath 302; Fig. 3A, paragraph 0042; the shaft 308 is capable of being disposed at the distal end 302B of sheath 302), and the end is positioned concentrically within an inner diameter of the steerable sheath (the distal tip 322 of the shaft 308 is positioned concentrically within the inner diameter of the sheath 302; Fig. 3A);
forming a bend in the flexible, wherein forming the bend causes the tip to be steered toward an anatomical region within a patient (sheath 102 may be formed of a flexible material, for example, such that sheath 102 may be manipulated and/or delivered to one or more lumens within the subject, for example, to a kidney; Fig. 1, paragraph 0027);
retreating the flexible tube along the axis of the lumen, such that the lumen is open (shaft 308 may be removed proximally from sheath 302; Fig. 3A, paragraph 0043); and
aspirating a bodily object through the lumen via the tip (as discussed above, suction may be applied to the treatment site through sheath 302, for example, through lumen 302C, Fig. 3B, paragraph 0043).
However, Carlson does not explicitly disclose providing a steerable sheath including a steerable section.
Wei teaches providing a steerable sheath (sheath 10; Fig. 6, col. 6, paragraph 3) including a steerable section (the tubular wall 15 comprises a deflectable or bendable segment 16; Fig. 6, col. 6, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the sheath of Carlson to incorporate the teachings of Wei by adding a steerable section. Doing so increases the functionality of the sheath of Carlson by allowing the user to steer the sheath independently of the flexible tube, as is standard in the art.
Regarding claim 11, Carlson, as previously modified by Wei, discloses the method according to claim 9. Carlson further discloses delivering, via the lumen when the lumen is open, a first one or more tools to the anatomical region, (shaft 308 may be removed proximally from sheath 302. Additionally, an irrigation device 306 may be delivered through lumen 302C of sheath 302 … Irrigation fluid may be delivered through irrigation device 306 and out of the distal opening 306D of irrigation lumen; Fig. 3B, paragraph 0043) and irrigating, via the lumen when the lumen is open, the anatomical region (proximal end 102A of sheath 102 may be coupled to one or more of a fluid source (e.g. a fluid pump; paragraph 0027).
Claims 15-16, 19-20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of U.S. Patent Appl. Publ. No. 2024/0407772 A1 to Gafford et al. (“Gafford”).
Regarding claim 15, Carlson discloses a device for performing endoscopic surgery within a patient (aspects of this disclosure may be used in performing an endoscopic, hysteroscope, or ureteroscopic procedure; Fig. 1, paragraph 0023 and 0026) comprising:
a flexible sheath including a tip (sheath 102 may be generally tubular, for example, including a distal end 102B; Fig. 1, paragraph 0026), a lumen (sheath 102 may be generally tubular, for example, including … a lumen 102C extending from proximal end 102A to a distal end 102B; Fig. 1, paragraph 0026), and a flexible section that is configured to be actuated to form a bend, such that the tip is operable to be steered toward an anatomical region within the patient (sheath 102 may be formed of a flexible material, for example, such that sheath 102 may be manipulated and/or delivered to one or more lumens within the subject, for example, to a kidney; Fig. 1, paragraph 0027);
a flexible tube (medical device 104 includes a shaft 108; Fig. 1, paragraph 0026) including an end (a distal tip 122 of shaft 108; Fig. 1, paragraph 0028) and a working channel disposed on the end, the working channel is operable to aspirate a bodily object (suction may be applied through the working channel so that particles and/or dust from the one or more objects are removed through opening 334 of the working channel; Fig. 3A, paragraph 0042);
a light source disposed on the end (distal tip 322 of shaft 308 may include one or more illumination devices 330; Fig. 3A, paragraph 0042); and
an image sensor disposed on the end (distal tip 332 of shaft 308 may include … one or more imaging devices 332; Fig. 3A, paragraph 0042),
wherein the flexible tube is disposed within the lumen such that the end is positioned at the tip (a shaft 308 may be positioned within (e.g. radially within) a sheath 302, and a distal tip 322 of shaft 308 may extend distally beyond a distal end 302B of sheath 302; Fig. 3A, paragraph 0042; the shaft 308 is capable of being disposed at the distal end 302B of sheath 302),
wherein the flexible tube is configured to be removed from the lumen (shaft 308 may be removed proximally from sheath 302; Fig. 3A, paragraph 0043), such that the end is removed from the tip and the lumen is operable to aspirate a bodily object (as discussed above, suction may be applied to the treatment site through sheath 302, for example, through lumen 302C, Fig. 3B, paragraph 0043).
However, Carlson does not explicitly disclose wherein the steerable section includes a concentric tube structure having nested concentric tubes, and wherein actuation of the steerable section is effectuated through applying an axial push-pull force to the concentric tubes.
Gafford teaches wherein the steerable sheath includes a concentric tube structure having nested concentric tubes (a steerable instrument 20, includes an inner tube 22 and an outer tube 24 that are configured to be nested, with the inner tube being inserted into the outer tube, as indicated generally by the dashed line in Fig. 2A; Fig. 2A-C, paragraph 0078 and 0084), and wherein actuation of the steerable section is effectuated through applying an axial push-pull force to the concentric tubes (actuation of the bending segment 40 is effectuated through relative axial motion between nested tubes 22, 24 in a push/pull manner; Fig. 2A-C, paragraph 0087). Gafford teaches that the steering function helps to access difficult to reach locations within the patient anatomy (paragraph 0080).
Gafford is considered to be analogous to the claimed invention because it is the same field of steerable tubes used to deliver medical tools. 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 steerable sheath of Carlson to incorporate the teachings of Gafford by including a concentric tube structure having nested concentric tubes for controlled manipulation of the steerable sheath. Doing so would help the sheath access difficult to reach locations within the patient anatomy, as recognized by Gafford.
Regarding claim 16, Carlson, as previously modified by Gafford, discloses the device according to claim 15. Carlson further discloses comprising a handle (handle 110; Fig. 1, paragraph 0028) including a passage and an aspiration port in communication with the working channel (ports 114 may fluidly connected to a working channel (not shown) in shaft 108 with a distal opening 234 (fig. 2A) at a distal tip 122 of shaft 108. Port(s) 114 may connect to the working channel through at least one internal lumen (not shown) in handle 110; Fig. 1, paragraph 0028), such that each of the working channel and the lumen are operable to aspirate a bodily object from the end to the aspiration port (suction may be applied through the working channel so that particles and/or dust from the one or more objects are removed through opening 334 of the working channel; Fig. 3A, paragraph 0042).
Regarding claim 19, Carlson, as previously modified by Gafford, discloses the device according to claim 15. Carlson further discloses wherein the flexible tube further includes an irrigation channel configured to irrigate the anatomical region (irrigation fluid may be delivered out of distal opening 334 of the working channel; Fig. 3A, paragraph 0042).
Regarding claim 20, Carlson, as previously modified by Gafford, discloses the device according to claim 15. Carlson further discloses wherein the working channel is further operable to deliver a first one or more tools to the anatomical region (a laser fiber or other energy delivery device may be delivered to the treatment site (e.g., through the working channel or integrated in distal tip 322 of shaft 308); Fig. 3A, paragraph 0042).
Regarding claim 23, Carlson, as previously modified by Gafford, discloses the device according to claim 15. Carlson further discloses wherein the flexible tube is disposed within the lumen such that the end is positioned concentrically within an inner diameter of the steerable sheath (the distal tip 322 of the shaft 308 is positioned concentrically within the inner diameter of the sheath 302; Fig. 3A).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei, as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0231417 A1 to Sartor et al. (“Sartor”).
Regarding claim 2, Carlson, as previously modified by Wei, discloses the device according to claim 1. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein the steerable sheath has a wall thickness of between about one twentieth millimeters and one fifth millimeters.
Sartor teaches wherein the steerable sheath has a wall thickness of between about one twentieth millimeters and one fifth millimeters (outer tube 36 may be extruded or otherwise extruded and formed and may have a wall thickness in a range of from about .05mm to about .5mm, in an embodiment…. In still another embodiment, the wall thickness is about .2mm; Fig. 1, paragraph 0047). Sartor teaches that decreasing wall thickness of the sheath helps allow surgical tools to be inserted into the sheath alongside an endoscope and to rotate freely within (paragraph 0065).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0074] indicating the wall thickness TI “may” be within the claimed range).
Sartor is considered to be analogous to the claimed invention because it is in the same field of sheaths with an imaging unit inserted within. 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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Sartor by making the wall thickness of the steerable sheath .2mm. Doing so would help allow a plurality of endoscopic tools to be inserted into and rotate freely within the sheath, as recognized by Sartor.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei, as applied to claim 1 above, and further in view of Gafford.
Regarding claim 7, Carlson, as previously modified by Wei, discloses the device according to claim 1. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein the steerable sheath includes a concentric tube structure having nested concentric tubes, and wherein actuation of the steerable section is effectuated through applying an axial push-pull force to the concentric tubes.
Gafford teaches wherein the steerable sheath includes a concentric tube structure having nested concentric tubes (a steerable instrument 20, includes an inner tube 22 and an outer tube 24 that are configured to be nested, with the inner tube being inserted into the outer tube, as indicated generally by the dashed line in Fig. 2A; Fig. 2A-C, paragraph 0078 and 0084), and wherein actuation of the steerable section is effectuated through applying an axial push-pull force to the concentric tubes (actuation of the bending segment 40 is effectuated through relative axial motion between nested tubes 22, 24 in a push/pull manner; Fig. 2A-C, paragraph 0087). Gafford teaches that the steering function helps to access difficult to reach locations within the patient anatomy (paragraph 0080).
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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Gafford by including a concentric tube structure having nested concentric tubes for controlled manipulation of the steerable sheath. Doing so would help the sheath access difficult to reach locations within the patient anatomy, as recognized by Gafford.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei, as applied to claim 9 above, and further in view of U.S. Patent Appl. Publ. No. 2006/0252993 A1 to Freed et al. (“Freed”).
Regarding claim 12, Carlson, as previously modified by Wei, discloses the method according to claim 9. Carlson further discloses wherein the flexible tube includes a working channel configured to deliver a second one or more tools to the anatomical region (a laser fiber or other energy delivery device may be delivered to the treatment site (e.g., through the working channel 334 or integrated in distal tip 322 of shaft 308; Fig. 3A, paragraph 0042) and an irrigation channel configured to irrigate the anatomical region (irrigation fluid may be delivered out of distal opening 334 of the working channel; Fig. 3A, paragraph 0042), and wherein a first inner diameter of the lumen is greater than a second inner diameter of the working channel (the inner diameter of lumen 302C is greater than an inner diameter of distal opening 334; Fig. 3A). However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein the working channel and the irrigation channel are separate channels such that a first inner diameter of the lumen is greater than each of a second inner diameter of the working channel and a third inner diameter of the irrigation channel.
Freed teaches wherein the flexible tube includes a working channel configured to deliver a second one or more tools to the anatomical region and an irrigation channel configured to irrigate the anatomical region (the catheter body 176 may further include additional channels 196, 198 for use, e.g., as irrigation channels or additional working channels. The channels 196, 198 each extend the entire length of the catheter and, like the working channel 192, allow the passage of devices, liquids, and/or gasses to and from the treatment area; Fig. 5A, paragraph 0067), and
wherein a first inner diameter of the lumen is greater than each of a second inner diameter of the working channel and a third inner diameter of the irrigation channel (the inner diameter of channels 196, 198 of the catheter 130 must be smaller than the inner diameter of the working channel of the insertion tube 142 as the catheter 130 fits into the working channel of the insertion tube 142; Fig. 1).
Freed is considered to be analogous to the claimed invention because it is the same field of a steerable sheath with a flexible tube inserted into it. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated to include separate channels for irrigation and inserting tools in the flexible tube of Carlson, as taught by Freed, to increase the functionality of the flexible tube of Carlson by enabling both irrigation and tool insertion to occur at the same time.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Gafford, as applied to claim 15 above, and further in view of Sartor.
Regarding claim 17, Carlson, as previously modified by Gafford, discloses the device according to claim 15. However, Carlson, as previously modified by Gafford, fails to explicitly disclose wherein the steerable sheath has a wall thickness of between one twentieth millimeters and one fifth millimeters.
Sartor teaches wherein the steerable sheath has a wall thickness of between one twentieth millimeters and one fifth millimeters (outer tube 36 may be extruded or otherwise extruded and formed and may have a wall thickness in a range of from about .05mm to about .5mm, in an embodiment…. In still another embodiment, the wall thickness is about .2mm; Fig. 1, paragraph 0047). Sartor teaches that decreasing wall thickness of the sheath helps allow surgical tools to be inserted into the sheath alongside an endoscope and to rotate freely within (paragraph 0065).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0074] indicating the wall thickness TI “may” be within the claimed range).
Sartor is considered to be analogous to the claimed invention because it is in the same field of sheaths with an imaging unit inserted within. 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 steerable sheath of Carlson, as modified by Gafford, to incorporate the teachings of Sartor by making the wall thickness of the steerable sheath .2mm. Doing so would help allow a plurality of endoscopic tools to be inserted into and rotate freely within the sheath, as recognized by Sartor.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei, as applied to claims 1 and 9 above, and further in view of U.S. Patent Appl. Publ. No. 2021/0338064 A1 to Fitterer et al. (“Fitterer”).
Regarding claim 21, Carlson, as previously modified by Wei, discloses the device according to claim 1. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein when the flexible tube is inserted within the lumen and the passage, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath.
Fitterer teaches wherein when the flexible tube is inserted within the lumen and the passage, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath (the camera head 171 of the slidable imaging probe 170 is disposed at or near a distal face 111 of the elongated shaft 110; Fig. 1A, paragraph 0073).
Fitterer is considered to be analogous to the claimed invention because it is the same field of a steerable sheath with a flexible tube inserted into it. 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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Fitterer by making the end flush with the inner diameter of the steerable sheath. It would have been obvious to one of ordinary skill in the art to adopt the flush configuration taught by Fitterer, as the extension position of the flexible tube relative to the distal tip represents a variable with a finite number of predictable options (e.g., retracted, flush, or extended), and the flush position in a known alternative. As stated by the Supreme Court, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Regarding claim 22, Carlson, as previously modified by Wei, discloses the method according to claim 9. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein when the flexible tube is advanced along the axis of the lumen, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath.
Fitterer teaches wherein when the flexible tube is advanced along the axis of the lumen, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath (the camera head 171 of the slidable imaging probe 170 is disposed at or near a distal face 111 of the elongated shaft 110; Fig. 1A, paragraph 0073).
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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Fitterer by making the end flush with the inner diameter of the steerable sheath. It would have been obvious to one of ordinary skill in the art to adopt the flush configuration taught by Fitterer, as the extension position of the flexible tube relative to the distal tip represents a variable with a finite number of predictable options (e.g., retracted, flush, or extended), and the flush position in a known alternative. As stated by the Supreme Court, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Gafford, as applied to claim 15 and 23 above, and further in view of Fitterer.
Regarding claim 22, Carlson, as previously modified by Wei, discloses the method according to claim 9. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein when the flexible tube is advanced along the axis of the lumen, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath.
Fitterer teaches wherein when the flexible tube is advanced along the axis of the lumen, such that the light source and the image sensor are positioned at the tip, the end is flush with the inner diameter of the steerable sheath (the camera head 171 of the slidable imaging probe 170 is disposed at or near a distal face 111 of the elongated shaft 110; Fig. 1A, paragraph 0073).
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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Fitterer by making the end flush with the inner diameter of the steerable sheath. It would have been obvious to one of ordinary skill in the art to adopt the flush configuration taught by Fitterer, as the extension position of the flexible tube relative to the distal tip represents a variable with a finite number of predictable options (e.g., retracted, flush, or extended), and the flush position in a known alternative. As stated by the Supreme Court, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei and Sartor, as applied to claim 2 above, and further in view of U.S. Patent Appl. Publ. No. 2023/0248434 A1 to Altshuler et al. (“Altshuler”).
Regarding claim 3, Carlson, as previously modified by Wei and Sartor, discloses the device according to claims 1-2. However, Carlson, as modified by Wei and Sartor, fails to explicitly disclose wherein the steerable sheath has an outer diameter of between about two and three tenths millimeters and about four millimeters.
Altshuler teaches a ureteroscope with an outer diameter of between about two and three tenths millimeters and about four millimeters (a distal tip of a conventional endoscope having an outer diameter of 3 millimeters at the distal tip; Fig. 2, paragraph 0163).
Altshuler is considered to be analogous to the claimed invention because it is in the same field of medical devices used during ureteroscopic procedures. As the maximum diameter of the stones capable of being suctioned is a variable that can be modified, among others, by adjusting the outer diameter of the sheath, with the maximum diameter of the stones capable of being suctioned increasing as the outer diameter of the sheath is increased, the precise outer diameter of the sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed outer diameter of the sheath cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the outer diameter of the sheath in Carlson to obtain the desired balance between the size of the treatment area in which the device is inserted into and the size of stones capable of being suctioned into the working channel of the sheath as taught by Altshuler (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Wei, as applied to claim 9 above and further in view of Sartor and Altshuler.
Regarding claim 10, Carlson, as previously modified by Wei, discloses the method according to claim 9. However, Carlson, as previously modified by Wei, fails to explicitly disclose wherein the steerable sheath has a wall thickness of between one twentieth millimeters and one fifth millimeters, and wherein the steerable sheath has an outer diameter of between two and three tenths millimeters and about four millimeters.
Sartor teaches wherein the steerable sheath has a wall thickness of between about one twentieth millimeters and one fifth millimeters (outer tube 36 may be extruded or otherwise extruded and formed and may have a wall thickness in a range of from about .05mm to about .5mm, in an embodiment…. In still another embodiment, the wall thickness is about .2mm; Fig. 1, paragraph 0047). Sartor teaches that decreasing wall thickness of the sheath helps allow surgical tools to be inserted into the sheath alongside an endoscope and to rotate freely within (paragraph 0065).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0074] indicating the wall thickness TI “may” be within the claimed range).
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 steerable sheath of Carlson, as modified by Wei, to incorporate the teachings of Sartor by making the wall thickness of the steerable sheath .2mm. Doing so would help allow a plurality of endoscopic tools to be inserted into and rotate freely within the sheath, as recognized by Sartor.
Furthermore, Altshuler teaches a ureteroscope with an outer diameter of between two and three tenths millimeters and four millimeters (a distal tip of a conventional endoscope having an outer diameter of 3 millimeters at the distal tip; Fig. 2, paragraph 0163).
As the maximum diameter of the stones capable of being suctioned is a variable that can be modified, among others, by adjusting the outer diameter of the sheath, with the maximum diameter of the stones capable of being suctioned increasing as the outer diameter of the sheath is increased, the precise outer diameter of the sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed outer diameter of the sheath cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the outer diameter of the sheath in Carlson to obtain the desired balance between the size of the treatment area in which the device is inserted into and the size of stones capable of being suctioned into the working channel of the sheath as taught by Altshuler (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Carlson, as modified by Gafford and Sartor, as applied to claim 16 above, and further in view of Altshuler.
Regarding claim 18, Carlson, as previously modified by Gafford and Sartor, discloses the device according to claims 15-16. However, Carlson, as modified by Gafford and Sartor, fails to explicitly disclose wherein the steerable sheath has an outer diameter of between two and three tenths millimeters and four millimeters.
Altshuler teaches a ureteroscope with an outer diameter of between two and three tenths millimeters and four millimeters (a distal tip of a conventional endoscope having an outer diameter of 3 millimeters at the distal tip; Fig. 2, paragraph 0163).
As the maximum diameter of the stones capable of being suctioned is a variable that can be modified, among others, by adjusting the outer diameter of the sheath, with the maximum diameter of the stones capable of being suctioned increasing as the outer diameter of the sheath is increased, the precise outer diameter of the sheath would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed outer diameter of the sheath cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the outer diameter of the sheath in Carlson to obtain the desired balance between the size of the treatment area in which the device is inserted into and the size of stones capable of being suctioned into the working channel of the sheath as taught by Altshuler (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
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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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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