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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
Response to Amendment
The amendment filed 06/24/2026 has been entered. Claims 1, 4-16, 21-26 are pending in the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 1, 8, 10-13, 15-16, 21-22, 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon ‘333 (WO 2017/210333) in view of in view of Kuntz (US 4,790,809) and further in view of Nakade (US 2017/0095138).
Regarding Claim 1, Gordon ‘333 discloses a medical tool (Device of Fig 5B), comprising: a sheath (670, Fig 21; Para 0098, lines 1-2 indicates that the sheath 304 in Fig 5B can be sheath 670) comprising: a tubular shaft member (674, Fig 22) including a sheath channel (676, Fig 22); and a guard member (672, Fig 22) coupled to a distal portion of the tubular shaft member (See Fig 22), wherein the guard member comprises an elongate body comprising: a first section comprising a plurality of barbs (“teeth”), the first section being a rigid distal section (Para 0098); and an elongate instrument (32, Fig 5A) sized for passage within the sheath channel (Para 0072), the elongate instrument comprising a flexible tubular section (portion 310 including the slits, Fig 5A) and a rigid tip (309, Fig 5A) extending from a distal portion of the flexible tubular section (Para 0073).
Gordon ‘333 is silent regarding wherein each barb comprises a distal facing edge and a second section integrally formed with the first section, the second section comprising a plurality of slits, the second section being a flexible proximal section that is more flexible than the rigid distal section
Kuntz teaches an analogous member comprising a rigid distal section (23, Fig 4), wherein the rigid distal section comprises a plurality of barbs (26, Fig 4), and wherein each barb comprises a distal facing edge (Col 3, lines 53-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teeth to be barbs comprising a distal facing edge as barbs are a well-known type of teeth for attaching tube elements to ensure the rigid distal section cannot fall off (Para 0098 -Gordon ‘333; Col 3, lines 60-63-Kuntz).
The modified invention of Gordon ‘333 and Kuntz discloses all of the elements of the invention as discussed above, however, is silent regarding a second section integrally formed with the first section, the second section comprising a plurality of slits, the second section being a flexible proximal section that is more flexible than the rigid distal section.
Nakade teaches an analogous sheath (2, Fig 1) comprising: a tubular shaft member (22, Fig 2) including a sheath channel (inner channel best seen in Fig 3); and a member (21, Fig 2) coupled to a distal portion of the tubular shaft member, wherein the member comprises an elongate body comprising: a first section (6, Fig 4), the first section being a rigid distal section (there are no bending slits to allow bending that the distal end); and a second section (7, Fig 4) integrally formed with the first section, the second section comprising a plurality of slits (24, 25, Fig 4), the second section being a flexible proximal section that is more flexible than the rigid distal section (Para 0038; the bending portion has slits to allow for a higher degree of flexibility wherein the distal end 6 is not provided with slits).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guard member to comprise a second section comprising a plurality of slits as taught by Nakade in order to have a sheath that provides improved insertability into a subject (Para 0007-0009).
Regarding Claim 8, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the elongate instrument further comprises a flexible jacket (318, Fig 5A -Gordon ‘333) covering at least a portion of the body wall (Para 0076 -Gordon ‘333).
Regarding Claim 10, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the flexible jacket (318, Fig 5A -Gordon ‘333) extends into at least a portion of a plurality of slits of the flexible tubular section of the elongate instrument (Para 0076, lines 1-3 -Gordon ‘333).
Regarding Claim 11, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the flexible jacket (318, Fig 5A -Gordon ‘333) includes a distal portion disposed distally of a proximal end of the guard member in both an extended configuration and a retracted configuration (Para 0077; See Fig 12A -Gordon ‘333; the flexible jacket is distal to a proximal end of the guard member in the configuration Seen in Fig 12A (extended configuration) and would also be in alight less extended position (retracted configuration). The claim language does not require the retracted position to be fully retracted or wherein the needle is no longer extending from the distal end of the sheath).
Regarding Claim 12, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the rigid distal section of the guard member includes a head portion with a tapered outer circumference (680, Fig 22; Para 0098 -Gordon ‘333).
Regarding Claim 13, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the rigid distal section includes a tapered distal opening (678, Fig 22; Para 0098 -Gordon ‘333).
Regarding Claim 15, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the flexible tubular section includes a body wall with a plurality of slits (314, Fig 5A) (Para 0074).
Regarding Claim 16, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the flexible proximal section of the guard member is configured to flex along with the flexible tubular section of the elongate instrument (Para 0074, 0078 -Gordon ‘333).
Regarding Claim 21, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the distal facing edge of each barb (26, Fig 4 -Kuntz) in an annular edge (See Fig 4 -Kuntz).
Regarding Claim 22, Gordon ‘333 discloses a medical tool (Device of Fig 5B), comprising: a sheath (670, Fig 21; Para 0098, lines 1-2 indicates that the sheath 304 in Fig 5B can be sheath 670) comprising: a tubular shaft member (674, Fig 22) including a sheath channel (676, Fig 22); and a guard member (672, Fig 22) coupled to a distal portion of the tubular shaft member (See Fig 22), wherein the guard member comprises an elongate body comprising: a first section comprising a plurality of ridges (“teeth”), the first section being a rigid distal section (Para 0098); and an elongate instrument (32, Fig 5A) sized for passage within the sheath channel (Para 0072), the elongate instrument comprising a flexible tubular section (portion 310 including the slits, Fig 5A) and a rigid tip (309, Fig 5A) extending from a distal portion of the flexible tubular section (Para 0073).
Gordon ‘333 is silent regarding wherein an outer diameter of a distal end of each ridge is larger than an outer diameter of a proximal end of each ridge and a second section integrally formed with the first section, the second section comprising a plurality of slits, the second section being a flexible proximal section that is more flexible than the rigid distal section
Kuntz teaches an analogous member comprising a rigid distal section (23, Fig 4), wherein the rigid distal section comprises a plurality of ridges (26, Fig 4), and wherein an outer diameter of a distal end of each ridge is larger than an outer diameter of a proximal end of each ridge (See Fig 4; Col 3, lines 53-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teeth to be barbs or ridges having an outer diameter of a distal end being larger than an outer diameter of a proximal end as barbs are a well-known type of teeth for attaching tube elements to ensure the rigid distal section cannot fall off (Para 0098 -Gordon ‘333; Col 3, lines 60-63-Kuntz).
The modified invention of Gordon ‘333 and Kuntz discloses all of the elements of the invention as discussed above, however, is silent regarding a second section integrally formed with the first section, the second section comprising a plurality of slits, the second section being a flexible proximal section that is more flexible than the rigid distal section.
Nakade teaches an analogous sheath (2, Fig 1) comprising: a tubular shaft member (22, Fig 2) including a sheath channel (inner channel best seen in Fig 3); and a member (21, Fig 2) coupled to a distal portion of the tubular shaft member, wherein the member comprises an elongate body comprising: a first section (6, Fig 4), the first section being a rigid distal section (there are no bending slits to allow bending that the distal end); and a second section (7, Fig 4) integrally formed with the first section, the second section comprising a plurality of slits (24, 25, Fig 4), the second section being a flexible proximal section that is more flexible than the rigid distal section (Para 0038; the bending portion has slits to allow for a higher degree of flexibility wherein the distal end 6 is not provided with slits).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guard member to comprise a second section comprising a plurality of slits as taught by Nakade in order to have a sheath that provides improved insertability into a subject (Para 0007-0009).
Regarding Claim 24, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the rigid distal section of the guard member includes a head portion with a tapered outer circumference (680, Fig 22; Para 0098 -Gordon ‘333).
Regarding Claim 25, the modified invention of Gordon ’333, Kuntz, and Nakade discloses the flexible proximal section of the guard member is configured to flex along with the flexible tubular section of the elongate instrument (Para 0074, 0078 -Gordon ‘333).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon ‘333 (WO 2017/210333) in view of in view of Kuntz (US 4,790,809) and further in view of Nakade (US 2017/0095138) and further in view of Gordon (US 10,856,855).
Regarding Claim 4, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention, however, is silent regarding the guard member has a length of approximately 8-10mm, and wherein the rigid distal section of the guard member has a length of approximately 5mm.
Gordon teaches an analogous guard member having a rigid distal section and a flexible proximal section wherein the guard member has a length of approximately 8-10mm (L2+L3 = 3.04mm-81.08mm), and wherein the rigid distal section (L3) of the guard member has a length of approximately 5mm (L3 = 0.5mm-5.08mm) (Col 16, line 58 - Col 17, line 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the guard member to be the lengths as taught by Gordon in order have a device that is dimensioned to reach a target tissue with enhanced steerability, stability, and distance/trajectory control (Col 7, lines 5-26).
Claims 5-7 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon ‘333 (WO 2017/210333) in view of in view of Kuntz (US 4,790,809) and further in view of Nakade (US 2017/0095138) and further in view of Snyder (US 2003/0009208).
Regarding Claim 5, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention as discussed above, however, is silent regarding the guard member further comprises a transition section between the flexible proximal section and the rigid distal section, the transition section being more flexible than the rigid distal section and less flexible than the flexible proximal section.
Snyder teaches a sheath (100, Fig 1) with a rigid section (112, Fig 1) and a flexible section (114, Fig 1) and a transition section (113, Fig 1) between the flexible section and the rigid section, the transition section being more flexible than the rigid section and less flexible than the flexible section (Para 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guard member to have a transition section between the flexible proximal section and the rigid distal section in order to control the angle or radius of curvature of the device (Para 0005).
Regarding Claim 6, the modified invention of Gordon ’333, Kuntz, Nakade, and Snyder discloses the transition section of the guard member comprises a plurality of slits having varying spacing between adjacent slits forming a gradient along a length of the transition section (“the spacing of cuts 110 may vary gradually from portion 113 to portion 114 “, Para 0033 -Snyder).
Regarding Claim 7, the modified invention of Gordon ’333, Kuntz, Nakade, and Snyder discloses the flexible proximal section of the guard member comprises a first plurality of slits and the transition section of the guard member comprises a second plurality of slits and wherein a spacing between adjacent slits of the second plurality of slits is greater than a spacing between adjacent slits of the first plurality of slits (Para 0033 -Snyder) or a width of each slit of the second plurality of slits is less than a width of each slit of the first plurality of slits.
Regarding Claim 23, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention as discussed above, however, is silent regarding the guard member further comprises a transition section between the flexible proximal section and the rigid distal section, the transition section being more flexible than the rigid distal section and less flexible than the flexible proximal section.
Snyder teaches a sheath (100, Fig 1) with a rigid section (112, Fig 1) and a flexible section (114, Fig 1) and a transition section (113, Fig 1) between the flexible section and the rigid section, the transition section being more flexible than the rigid section and less flexible than the flexible section (Para 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guard member to have a transition section between the flexible proximal section and the rigid distal section in order to control the angle or radius of curvature of the device (Para 0005).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon ‘333 (WO 2017/210333) in view of in view of Kuntz (US 4,790,809) and further in view of Nakade (US 2017/0095138) and further in view of Yoon (US 5226426).
Regarding Claim 9, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention as discussed above, however, is silent regarding the flexible jacket has a chamfered distal end.
Yoon teaches a flexible jacket or sleeve (36, Fig 1; Col 6, lines 10-13) covering a body wall of an elongated tubular member (32, Fig 3), wherein the flexible jacket including a chamfered distal end (98, Fig 3) terminating proximally of the opening (Col 6, lines 9-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible jacket disclosed by Gordon to have a chamfered distal end as taught by Yoon in order to have a jacket that can smoothly follow the needle during tissue penetration (Col 6, lines 9-14).
Claims 14 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon ‘333 (WO 2017/210333) in view of in view of Kuntz (US 4,790,809) and further in view of Nakade (US 2017/0095138) and further in view of Kato (US 2022/0096791).
Regarding Claim 14, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention, however, is silent regarding the proximal end of the flexible proximal section of the guard member includes a tapered profile.
Kato teaches an analogous member wherein a proximal end of a proximal section includes a tapered profile (15T, Fig 2) (Para 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the flexible proximal section to have a tapered profile as taught by Kato in order to provide a guide for a tip of the elongate instrument (Para 0068).
Regarding Claim 26, the modified invention of Gordon ’333, Kuntz, and Nakade discloses all of the elements of the invention, however, is silent regarding the proximal end of the flexible proximal section of the guard member includes a tapered profile.
Kato teaches an analogous member wherein a proximal end of a proximal section includes a tapered profile (15T, Fig 2) (Para 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the flexible proximal section to have a tapered profile as taught by Kato in order to provide a guide for a tip of the elongate instrument (Para 0068).
Response to Arguments
Applicant’s arguments filed 06/24/2026, on pages 6-9 regarding the current art of record failing to teach the amended limitations have been fully considered but are moot in view of the current rejection that relies on Gordon ‘333, Kuntz, and Nakade to teach all of the elements of the amended claims. This new rejection relies on Gordon ‘333 that has a similar configuration to the disclosed invention. Wherein Kuntz and Nakade are relied upon to teach the barbs and second flexible section that Gordon ‘333 lacks.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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