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 01/16/2026 has been entered. Claims 1-2, 4-16, 21-25 are pending in the application. Applicant' s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 10/21/2025.
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 1-2, 4, 12-14, 21, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 10,856,855) in view of Kuntz (US 4,790,809).
Regarding Claim 1, Gordon discloses a medical tool, comprising: a sheath (310, Fig 4) comprising: a tubular shaft member (315, Fig 4) including a sheath channel; and a guard member (320, 325, Fig 4) coupled to a distal portion of the tubular shaft member (See Fig 4), wherein the guard member comprises a rigid distal section (325, Fig 4) and a flexible proximal section (320, Fig 4) that is more flexible than the rigid distal section (Col 17, lines 9-20); and an elongate instrument (225, Fig 2) sized for passage within the sheath channel (Col 16, lines 28-36), the elongate instrument comprising a flexible tubular section and a rigid tip extending from a distal portion of the flexible tubular section (Col 11, lines 18-23).
Gordon discloses the rigid distal section of the guard member comprises mechanical fasteners (Col 17, lines 21-25), however, is silent regarding the rigid distal section comprises a plurality of barbs, and wherein each barb comprises a distal facing edge.
Kuntz teaches an analogous member comprising a rigid distal section (23, Fig 4) and a flexible proximal section (10, Fig 1), 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 60-63).
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 mechanical fasteners to be barbs as barbs are a known method of attaching tube elements to ensure the rigid distal section cannot fall off (Col 17, lines 21-25 -Gordon; Col 3, lines 60-63-Kuntz).
Regarding Claim 2, the modified invention of Gordon and Kuntz discloses the flexible proximal section (320, Fig 4 -Gordon) of the guard member comprises a plurality of slits (385, Fig 9 -Gordon) (Col 18, lines 56-66 -Gordon).
Regarding Claim 4, the modified invention of Gordon and Kuntz discloses the guard member (320, 325, Fig 4 -Gordon) has a length of approximately 8-10mm (the guard member length = L2+L3 = 3.04 – 81.08mm), and wherein the rigid distal section of the guard member has a length of approximately 5mm (rigid distal section length = L3 = 0.5 – 5.08mm) (Col 16, lines 58 – Col 17, lines 8 -Gordon).
Regarding Claim 12, the modified invention of Gordon and Kuntz discloses the rigid distal section (325, Fig 4 -Gordon) of the guard member includes a head portion with a tapered outer circumference (Col 20, lines 11-24; See Fig 11 -Gordon).
Regarding Claim 13, the modified invention of Gordon and Kuntz discloses the rigid distal section (325, Fig 4 -Gordon) includes a tapered distal opening (See taper 430, Fig 12 -Gordon).
Regarding Claim 14, the modified invention of Gordon and Kuntz discloses the proximal end of the flexible proximal section of the guard member includes a tapered profile (Col 17, lines 33-35 -Gordon).
Regarding Claim 21, the modified invention of Gordon and Kuntz discloses the distal facing edge of each barb (26, Fig 4 -Kuntz) in an annular edge (See Fig 4 -Kuntz).
Regarding Claim 22, Gordon discloses a medical tool, comprising: a sheath (310, Fig 4) comprising: a tubular shaft member (315, Fig 4) including a sheath channel; and a guard member (320, 325, Fig 4) coupled to a distal portion of the tubular shaft member (See Fig 4), wherein the guard member comprises a rigid distal section (325, Fig 4) and a flexible proximal section (320, Fig 4) that is more flexible than the rigid distal section (Col 17, lines 9-20); and an elongate instrument (225, Fig 2) sized for passage within the sheath channel (Col 16, lines 28-36), the elongate instrument comprising a flexible tubular section and a rigid tip extending from a distal portion of the flexible tubular section (Col 11, lines 18-23).
Gordon discloses the rigid distal section of the guard member comprises mechanical fasteners (Col 17, lines 21-25), however, is silent regarding the rigid distal section comprises a plurality of ridges, 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.
Kuntz teaches an analogous member comprising a rigid distal section (23, Fig 4) and a flexible proximal section (10, Fig 1), 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 60-63).
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 mechanical fasteners to be a plurality of ridges as ridges are a known method of attaching tube elements to ensure the rigid distal section cannot fall off (Col 17, lines 21-25 -Gordon; Col 3, lines 60-63-Kuntz).
Regarding Claim 24, the modified invention of Gordon and Kuntz discloses the rigid distal section (325, Fig 4 -Gordon) of the guard member includes a head portion with a tapered outer circumference (Col 20, lines 11-24; See Fig 11 -Gordon).
Claims 5-7and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 10,856,855) in view of Kuntz (US 4,790,809) and further in view of Snyder (US 2003/0009208).
Regarding Claim 5, the modified invention of Gordon and Kuntz 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, Kuntz 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, Kuntz 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 and Kuntz 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).
Claims 8, 10-11, 15-16 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 10,856,855) in view of Kuntz (US 4,790,809) and further in view of Gordon ‘333 (WO 2017/210333).
Regarding Claim 8, the modified invention of Gordon and Kuntz discloses all of the elements of the invention as discussed above, however, is silent regarding the elongate instrument further comprises a flexible jacket covering at least a portion of the flexible tubular section.
Gordon teaches 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) attached to a distal portion of the tubular shaft member (See Fig 22), the guard member comprising: a head portion (678, Fig 22); an elongate body (682, Fig 22) sized for receipt within the sheath channel (See Fig 21); and a lumen extending through the head portion and the elongate body (See lumen within guard member 672 in Fig 22); and an elongate instrument (32, Fig 5A) sized for passage within the sheath channel (Para 0072), the elongate instrument comprising: a flexible elongated tubular section (portion 310 including the slits, Fig 5A) having a body wall; a rigid tip extending from a distal end of the tubular section, the rigid tip (309, Fig 5A) including an opening (312, Fig 5A); a flexible jacket (318, Fig 5A) covering at least a portion of the body wall; and the body wall comprises a plurality of slits (314, Fig 5A) (Para 0074).
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 elongated tubular section to comprise slits and a flexible jacket as taught by Gordon in order to have a desired flexibility profile in the flexible elongated tubular section while having a flexible jacket to prevent fluid from entering the elongate instrument through the slits (Para 0074 and 0076).
Regarding Claim 10, the modified invention of Gordon, Kuntz, and Gordon ‘333 discloses the flexible jacket (318, Fig 5A -Gordon ‘333) extends into at least a portion of a plurality of slits (Para 0076, lines 1-3 -Gordon ‘333) of the flexible tubular section of the elongate instrument.
Regarding Claim 11, the modified invention of Gordon, Kuntz and Gordon ‘333 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 (See Fig 5A of Gordon ‘333 and Figs 3A-3C of Gordon. Gordon ‘333 illustrates that the flexible jacket has a distal portion that extends at least over the slits and part of the rigid distal end of the elongated instrument 302. As seen in Figs 3A-3C of Gordon, the rigid distal section 270 is distal to the proximal end of the guard member 280 and 275. Thus, the combined device would meet the limitation).
Regarding Claim 15, the modified invention of Gordon and Kuntz discloses all of the elements of the invention as discussed above, however, is silent regarding the flexible tubular section includes a body wall with a plurality of slits.
Gordon ‘333 teaches 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) attached to a distal portion of the tubular shaft member (See Fig 22), the guard member comprising: a head portion (678, Fig 22); an elongate body (682, Fig 22) sized for receipt within the sheath channel (See Fig 21); and a lumen extending through the head portion and the elongate body (See lumen within guard member 672 in Fig 22); and an elongate instrument (32, Fig 5A) sized for passage within the sheath channel (Para 0072), the elongate instrument comprising: a flexible elongated tubular section (portion 310 including the slits, Fig 5A) having a body wall; a rigid tip extending from a distal end of the tubular section, the rigid tip (309, Fig 5A) including an opening (312, Fig 5A); a flexible jacket (318, Fig 5A) covering at least a portion of the body wall; and the body wall comprises a plurality of slits (314, Fig 5A) (Para 0074).
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 elongated tubular section to comprise slits and a flexible jacket as taught by Gordon in order to have a desired flexibility profile in the flexible elongated tubular section while having a flexible jacket to prevent fluid from entering the elongate instrument through the slits (Para 0074 and 0076).
Regarding Claim 16, the modified invention of Gordon, Kuntz, and Gordon ‘333 discloses flexible proximal section of the guard member is configured to flex along with the flexible tubular section of the elongate instrument (Col 18, lines 56-66 -Gordon) (Para 0074 -Gordon ‘333).
Regarding Claim 25, the modified invention of Gordon, Kuntz and Gordon ‘333 discloses flexible proximal section of the guard member is configured to flex along with the flexible tubular section of the elongate instrument (Col 18, lines 56-66 -Gordon) (Para 0074 -Gordon ‘333).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US 10,856,855) in view of Kuntz (US 4,790,809) and further in view of Gordon ‘333 (WO 2017/210333) and further in view of Yoon (US 5226426).
Regarding Claim 9, the modified invention of Gordon, Kuntz, and Gordon ‘333 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).
Response to Arguments
Applicant’s arguments filed 01/16/2026, on pages 7-9 regarding Gordon, Wang, Gordon ‘333, and Yoon failing to teach the limitations regarding the barbs and plurality of ridges of claims 1 and 22, respectively, have been fully considered but are moot in view of the current rejection that relies on Kuntz to teach the barbs and ridges.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights