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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 23rd, 2026 has been entered.
Response to Amendment
The amendment filed April 23rd, 2026 has been entered. Claims 29 & 47 are amended. Claims 1-28, 38, 42, 44, & 48 are canceled. Claims 29-37, 39-41, 43, & 45-47 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 29-37, 39-41, 43, & 45-47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 47 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 47 recites the limitation "the insulating material" in lines 21-22. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the examiner is considering “the insulating material” to be –an insulating material”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 29-37, 39-41, 43, & 45-46 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gon (US 20210106448 A1), hereinafter “Gon”.
Regarding claim 29, Gon discloses an apparatus comprising: an elongated medical dilator ([0054]; Figure 2—element 4) including: a cautery device being configured to selectively form, by cauterization, a tissue passage through a tissue portion of a living body ([0055]; Figure 2—element 43a); and a dilation device being positioned relative to the cautery device, and the dilation device being configured to dilate the tissue passage once the cautery device selectively formed the tissue passage ([0055]; Figure 2—element 43; the examiner is considering the dilation device to be the distal end tip 43 that comprises a truncated conical tip shape); wherein the elongated medical dilator includes a leading face portion having an inner edge and an outer edge ([0055]; Figure 2—element 43; see figure below; the examiner is considering the leading face portion to be the distal tip face/truncated portion of the truncated conical shape tip 43; the inner edge to be the inner edge near opening 4c of the leading face portion and the outer edge to be the exterior edge of the leading face portion; see figure below), and the cautery device is positioned on the leading face portion such that both an outer gap formed between the cautery device and the outer edge, an inner gap formed between the cautery device and the inner edge are formed of electrically insulating material of the elongated medical dilator ([0042] & [0055]; Figure 2—element 43a; see figure below; the medical dilator may be formed of various resin materials including polyolefins, etc.; the cautery device 43a is shown in Figure 2 as being positioned on the leading face portion and spaced apart from the inner edge and the outer edge, the examiner is considering the inner gap to be the space between the cautery device 43a and inner edge and the outer gap to be the space between the cautery device 43a and the outer edge; see figure below).
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Regarding claim 30, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein: the cautery device is fixedly positioned at the leading face portion of the distal tip of the elongated medical dilator ([0055]; Figure 2—element 43a).
Regarding claim 31, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses an elongated electrical conductor being aligned along a length of the elongated medical dilator ([0055]; Figure 2—element 44).
Regarding claim 32, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses an elongated electrical conductor being aligned along a length of a body portion of the elongated medical dilator ([0055]; Figure 2—elements 41 & 44).
Regarding claim 33, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein: the elongated medical dilator includes a proximal terminal; and the cautery device is configured to receive energy from the proximal terminal via an elongated electrical conductor ([0055] & [0059]; Figure 1—elements 7 & 8; Figure 2—element 44).
Regarding claim 34, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the cautery device is configured to avoid formation of a tissue core from the tissue portion to be cauterized once the cautery device is activated ([0055]; Figure 2—element 43a; as the cautery device 43a is shown as not extending fully around the leading face portion in Figure 2, it is the examiners position that the cautery device would be configured to avoid formation of a tissue core).
Regarding claim 35, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the dilation device is configured to mechanically ream a passageway through tissue ([0004], [0055], & [0067]; Figure 2—element 43).
Regarding claim 36, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the dilation device includes a sloped surface extending from a distal portion of the elongated medical dilator ([0055]; Figure 2—element 43; the distal end tip 43 has a truncated conical tip shape).
Regarding claim 37, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the cautery device includes a semicircular shaped body ([0055]; Figure 2—element 43a; the cautery device is shown in Figure 2 as having a semicircular shape).
Regarding claim 39, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the cautery device extends between opposite sides of an entrance leading into an elongated dilator cavity of the elongated medical dilator ([0055] & [0056]; Figure 2—element 4c).
Regarding claim 40, Gon discloses all of the limitations of claim 29, as described above.
Gon does further discloses wherein the cautery device includes a tab structure ([0055]; Figure 2—element 44; the examiner is considering the tab structure to be the conductive wire 44 which projects proximally from the electrode 43a).
Regarding claim 41, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the cautery device includes a semicircular shaped body ([0055]; Figure 2—element 43a; the cautery device is shown in Figure 2 as having a semicircular shape).
Regarding claim 43, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein: the leading face portion positioned at an entrance of an elongated dilator cavity ([0055] & [0056]; Figure 2—elements 4c & 41c); and the inner gap is configured to avoid an electrical short circuit between an elongated medical guidewire assembly and the cautery device, in which an elongated dilator cavity is configured to receive the elongated medical guidewire assembly ([0053]; the dilator 4 may have an outer diameter in which a sheath 21 can be inserted and may have an outer diameter different from the diameter of a general guide wire; it is the examiner position that the lumen 41c would be capable of receiving an elongated medical guidewire assembly and that the inner gap (as described in the above rejection of claim 29) would be capable of avoiding an electrical short between an elongated medical guidewire assembly or any device received within the lumen 41c and the cautery device 43a).
Regarding claim 45, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses wherein the elongated medical dilator includes an electrically-conductive material having a distal portion being electrically connected to the cautery device ([0055] & [0057]; Figure 2—element 41; inner elongated body 41 may be formed of a conductive material that functions as wire 44).
Regarding claim 46, Gon discloses all of the limitations of claim 29, as described above.
Gon further discloses a medical sheath defines an elongated interior passageway configured to receive the elongated medical dilator ([0054] & [0055]; Figure 2—element 42), and a geometry of an entrance of the medical sheath is adapted to avoid unwanted electrical contact between an elongated medical guidewire assembly and the cautery device ([0042] & [0053]; the dilator 4 may have an outer diameter in which a sheath 21 can be inserted and may have an outer diameter different from the diameter of a general guide wire; it is the examiner position that the lumen 41c would be capable of receiving an elongated medical guidewire; the sheath 42 is made of various resin materials including polyolefins, etc.; it is the examiner’s position that the sheath comprising the insulating resin material would be capable of avoiding unwanted electrical contact between an elongated medical guidewire assembly and the cautery device when the cautery device is positioned within the insulating sheath).
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 47 is rejected under 35 U.S.C. 103 as being unpatentable over Otsubo (previously presented- US 20190216503 A1), hereinafter “Otsubo”, in view of Nohilly (US 20080039883 A1), hereinafter “Nohilly”.
Regarding claim 47, as best understood in view of the 112(b) rejection above, Otsubo discloses an apparatus comprising: an elongated medical dilator having a dilator length being configured to be received into a confined space defined by a living body ([0038]; Figure 1—element 40); and the elongated medical dilator including a cautery device being configured to be positioned proximate to a tissue portion of the living body once the elongated medical dilator is received into the confined space defined by the living body; and the cautery device also being configured to selectively cauterize the tissue portion of the living body in such a way that the cautery device, once actuated, forms, by cauterization, a tissue passage through the tissue portion once the cautery device is positioned proximate to the tissue passage and is selectively actuated ([0040] & [0045]; Figures 1-4—elements 21/22; the examiner is considering the cautery device to be the conductive wire 22 and the electrode 21); and the elongated medical dilator also including a dilation device being positioned relative to the cautery device, and being configured to be received into the confined space defined by the living body; and the dilation device also being configured to support the cautery device; and the dilation device being configured to dilate the tissue passage once the cautery device selectively formed the tissue passage, and the dilation device is urged to move toward, and to make contact with, the tissue passage formed by the cautery device ([0039] & [0045]; Figures 1-4—element 42; the examiner is considering the dilation device to be the tapered portion of tip 42); and wherein the cautery device is embedded, at least in part, in a distal tip portion of the dilation device, and the cautery device is partially embedded with exposed portions extending distally beyond the insulating material of the dilation device, having a frontal extended section configured for non-coring puncture of the tissue portion ([0040], [0045], & [0062]; Figures 1-4 & 7—elements 21 & 22; the examiner is considering the cautery device 21/22 to be partially embedded in the lumen 46 of the dilation device 42 and the exposed portion to be the electrode 21 that extends distally of the dilation device 42) .
Otsubo does not disclose the cautery device includes an uninsulated electrical coil that is partially embedded with exposed portions, the uninsulated electrical coil having the frontal extended section configured for the non-coring puncture of the tissue portion.
Nohilly teaches a cautery device, the cautery device includes an uninsulated electrical coil that is partially embedded with exposed portions, the uninsulated electrical coil having the frontal extended section configured for the non-coring puncture of the tissue portion ([0045] & [0058]; an anti-coring device may use an electrosurgical cutting device such as an electrosurgical coil which is selectively covered and uncovered).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cautery device, as disclosed by Otsubo, to include wherein the cautery device includes an uninsulated electrical coil, as taught by Nohilly, as both references and the claimed invention are directed toward electrosurgical cautery devices for non-coring puncture of tissue. As disclosed by Otsubo, the cutting element may comprise a C-shape such that a hole in tissue is formed in accordance with the C-shape of the cutting element ([0062]). As disclosed by Nohilly, portions of the cutting element may be uncovered and covered in order to produce an anti-coring device, the cutting element may include an uninsulated electrical coil ([0045] & [0058]). 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 cautery device, as disclosed by Otsubo, to include wherein the cautery device includes an uninsulated electrical coil, as taught by Nohilly, as such a modification would provide for a suitable and known alternative electrode type that is configured for the non-coring puncture of the tissue portion.
Conclusion
Accordingly, claims 29-37, 39-41, 43, & 45-47 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Goble et al. (US 5944715 A) discloses an uninsulated electrical coil ([Col. 11, lines 54-64]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm 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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
