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 amendments filed 8/6/2026 overcome the objections and 112(b) rejections set forth in the last Office Action. They do not overcome the 103 rejections set forth in the last Office Action (as addressed in the “Response to Arguments” area below).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 79, 81-86, 88 and 91-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khalaj et al. (WO 2009/157927)1.
Re claim 79, Khalaj discloses a surgical tunneling tool 320 (Fig 12; it is noted that all reference characters cited below refer to Fig 12 unless otherwise noted), comprising: a flat flexible shaft 324 (Para 89 discloses that the tip can have facets that “give the shaft tip a generally flat screwdriver shape”), defining a first lengthwise axis (as seen in Fig 12), including a lumen (“lumen […] of shaft 324”, Para 81; not shown in Fig 12, but comparable to lumen 26 of Fig 3A) disposed along a length of the first lengthwise axis of the flexible shaft, the flexible shaft having a proximal end (to the right in Fig 12) and a distal end (to the left in Fig 12); a sheath (not shown in Fig 12 but disclosed in Para 79 : “the depicted tunneling device 320 comprises a shaft 324 that can be adapted to slidably receive a sheath (not shown)”), configured to deform to accommodate the flexible shaft (Para 54 discloses that the shaft can be bent into different shapes and Fig 5,6 show that the sheath deforms to accommodate those shapes), the sheath defining a second lengthwise axis, disposed along a second length of the flexible shaft, wherein the first lengthwise axis and the second lengthwise axis are parallel (although not shown in Fig 12, Fig 2A shows a sheath 40 that has a lengthwise axis that is parallel to the lengthwise axis of the flexible shaft), the sheath being sized for insertion of a subcutaneous electrode after removal of the flexible shaft from the sheath (it is noted that the phrase “being sized for insertion of a subcutaneous electrode after removal of the flexible shaft from the sheath” is a functional limitation and “a subcutaneous electrode” is not a part of the claimed “surgical tunneling tool”; accordingly, the sheath 40 only has to be structurally capable receiving a subcutaneous electrode after removal of the shaft from the sheath and this limitation is met in view of Para 59); a handle 322 disposed at the proximal end of the flexible shaft (as seen in Fig 12); a tip (extending proximally from the distal-most end of the shaft 324; since the “tip” can extend any distance proximally from the distal-most end of the shaft, the “tip” can be the portion of shaft 24/324 seen in Fig 3A) disposed at the distal end of the flexible shaft (as explained immediately above); and at least one orifice (“openings of the shaft 324”, Para 81; not shown in Fig 12, but comparable to openings 30 in Fig 3A), disposed proximate the distal end of the flexible shaft, in fluid communication with the lumen (Para 81; not shown in Fig 12, but seen in Fig 3A).
Re claim 81, Khalaj discloses that the at least one orifice in fluid communication with the lumen is disposed on the tip (since the “tip” can extend any distance proximally from the distal-most end of the shaft, the “tip” can be the portion of shaft 24/324 seen in Fig 3A).
Re claim 82, Khalaj discloses that the flexible shaft includes a connector (“fitting (not shown) at or near the proximal end of the handle’s interior cavity 376”, Para 80), in fluid communication with the lumen, configured to receive fluid from an external fluid source (Para 80,81).
Re claim 83, Khalaj discloses that the handle includes an actuator 396 to selectively pressurize fluid in the lumen (Para 81).
Re claim 84, Khalaj discloses that the actuator comprises a plunger (“plunger member 396”, Para 81).
Re claim 85, Khalaj discloses that the actuator actuates a mechanical pump 397 (Fig 13; Para 81).
Re claim 86, Khalaj discloses that the tip is one of a Hasson trocar and a blunt trocar (“blunt”, Para 50).
Re claim 88, Khalaj discloses that the sheath disposed along the second length of the flexible shaft includes a distal end disposed on the flexible shaft proximate the tip (not shown in Fig 12 but shown in Fig 2A).
Re claim 91, Khalaj discloses that each orifice of the at least one orifice defines a central axis (running vertically in Fig 3A) disposed centrally within the respective orifice (as seen in Fig 3A).
Re claim 92, Khalaj discloses that the central axis of each orifice of the at least one orifice is either parallel or perpendicular with the first lengthwise axis of the flexible shaft (as seen in Fig 3A, the central axes of the orifices 30 are perpendicular to the first lengthwise axis of the flexible shaft).
Re claim 93, Khalaj discloses that the at least one orifice includes a plurality of orifices (“a plurality of openings 30 may be positioned along the entire length of the lumen 26”, Para 43).
Re claim 94, Khalaj discloses that the plurality of orifices are disposed on the distal end of the flexible shaft proximate the tip (Para 43 discloses that the orifices can be “positioned along the entire length of the lumen 26”; thus, at least some of the orifices will be “proximate the tip”).
Re claim 95, Khalaj discloses at least one container 390 disposed in the handle (as seen in Fig 12), the at least one container in fluid communication with the lumen (Para 81).
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.
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj et al. (WO 2009/157927) in view of Shah et al. (PG PUB 2004/0073158).
Re claim 89, Khalaj discloses all the claimed features except echogenic particles disposed in at least one of the flexible shaft and the sheath. Shah, however, teaches an outer sheath 60 (Fig 7) and an inner flexible shaft 50 (Fig 6A,7) that includes echogenic particles (Para 34) to enable a user to visualize its position in the patient to facilitate navigation (Para 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify Khalaj to include the flexible shaft with echogenic particles, as taught by Shah, for the purpose of enabling a user to visualize the position of the flexible shaft in the patient to facilitate navigation (Para 4).
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj et al. (WO 2009/157927) in view of Elsberry (US Pat 5,846,220).
Re claim 90, Khalaj discloses all the claimed features except that the tip is porous. Elsberry, however, teaches a flexible shaft 10 (Fig 5) having a porous tip 34 (Fig 5; Col 6, Line 11) that allows for a more uniform volume distribution in a nearly 360 degree pattern, exposing the entire structure it is in to the fluid being delivered (Col 6, Lines11-17). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify Khalaj to include a porous tip, as taught by Elsberry, for the purpose of providing a more uniform volume distribution in a nearly 360 degree pattern, exposing the entire structure it is in to the fluid being delivered (Col 6, Lines11-17).
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over Khalaj et al. (WO 2009/157927) in view of Hamatake et al. (PG PUB 2006/0004325).
Re claim 96, as set forth in the rejection of claim 95 above, Khalaj discloses that the handle 322 includes a container 390 in fluid communication with the lumen and a first orifice (Para 79), but does not disclose that the handle includes a second container in fluid communication with a second lumen and a second orifice. Hamatake, however, teaches a multi-lumen catheter 2 (Fig 4A) with two lumen 154,156, each having an orifice 184,186 (respectively) at their distal ends (as seen in Fig 4B, Para 74), and a handle 142+144+146+148 (Fig 4A) comprising a first container (“fluid source”, Para 73) in communication with a first of the lumen and a first of the orifices (via tubing 144, Para 74) and a second container (“fluid source”, Para 73) in communication with a second of the lumen and a second of the orifices (via tubing 148, Para 74) for the purpose of providing independent fluid infusion/aspiration (Para 74). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify Khalaj to include the handle with a second container and the flexible shaft with a second lumen in communication with a second orifice, as taught by Hamatake, for the purpose of allowing the shaft to be used for independent fluid infusion/aspiration (Para 74).
Response to Arguments
Applicant's arguments filed 8/6/2026 have been fully considered but they are not persuasive.
Applicant argues that Khalaj does not disclose the entirety of the subject matter of claim 79; specifically, Applicant argues that Khalaj does not disclose a “flat flexible shaft” as claimed. The Examiner respectfully disagrees.
Applicant argues that Khalaj does not disclose “a flat flexible shaft” because (a) the tip having “a generally flat screwdriver shape” (as set forth in Para 89) does not make the flexible shaft “flat” as claimed and (b) “the shaft body to which the tip is attached is not described as flat in any respect”.
Regarding point (a), the claim does not require that the entirety of the flexible shaft must be flat. Rather, the shaft having a portion that is flat and possibly having a portion that is not flat, still results in a “flat flexible sheath” as currently claimed.
Regarding point (b), the claim does not recite a “shaft body”; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Accordingly, this argument is not persuasive.
Applicant argues that Khalaj’s tip itself “is not flat” in view of Para 89 that states that “the shaft tip retains a rounded distal end between the facets”. This is not persuasive because this paragraph clearly sets forth that the embodiment with “a rounded distal end between the facets 510” is a different embodiment from that in which the “facts 510 give the shaft tip a generally flat screwdriver shape”. Specifically, Para 89 recites “In some embodiments, such facets 510 give the shaft tip a generally flat screwdriver shape; however, preferably the shaft tip retains a rounded distal end between the facets 510”. Accordingly, this argument is not persuasive.
Applicant argues that the faceted-tip disclosure of Para 89 relates to an embodiment that is “distinct from the Figure 15 tunnelling device 320” used in the rejections. This is not persuasive because Para 88 explicitly recites that “Figs. 15 and 16 illustrate two arrangements of shaft tip designs for use on any of the tunneling device embodiments disclosed herein”. Accordingly, this argument is not persuasive.
Applicant argues that the disclosure of Para 50 that the distal end of the shaft is “generally rounded and, more particularly substantially spherical and is the same diameter as the shaft” and the disclosure of Para 44 that the lumen of the shaft “is concentric to the shaft” confirms that the shaft has a round cross-section. This is not persuasive for a number of reasons:
Para 50 is directed to the embodiment of Fig 1A and 2A, which are not used in the rejection of claim 79.
The term “concentric” does not require circular elements; rather, it just means under broadest reasonable interpretation that elements share a common center2.
As set forth above, the entirety of the flexible shaft is not claimed as being flat. Therefore, the shaft having a portion that is flat and possibly having a portion that is not flat, still results in a “flat flexible sheath” as currently claimed.
Applicant’s assertion regarding the “may vary” language of Khalaj is acknowledged. However, as the rejection of claim 79 does not use this teaching of Khalaj the assertion is moot.
Applicant’s assertion that Khalaj does not suggest flattening the shaft body is acknowledged. However, as the rejection of claim 79 does not suggest flattening the shaft body, this assertion is moot.
If Applicant wishes for the claim to be interpreted such that the entirety of the flexible shaft is flat, then further amendments are required to explicitly disclose that.
Applicant’s arguments directed to the rejections of the rest of the claims amount to the fact that none of the other cited references disclose a flat flexible shaft nor is there any reason to modify Khalaj’s shaft to be flat. These arguments are moot because, as set forth above, Khalaj does teach “a flat flexible shaft” as claimed.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 A copy of this reference was provided by the Applicant with the 2/28/2025 IDS.
2 “Concentric”. Merriam-Webster Dictionary. <https://www.merriam-webster.com/dictionary/concentric>
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