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 .
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7, 11, 12, 15, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Urbanski et al (2014/0206987).
Referring to claims 1 and 20, Urbanski et al teaches a medical puncture device comprising: a radiofrequency generator (700) (paragraph 0073; Figure 8); an elongate shaft (102) having a proximal portion defining a proximal end and a distal portion defining a distal end, wherein the distal portion tapers in outer diameter going towards the distal end to define a dilating tip (paragraph 0102; Figures 2E and 8), wherein a lumen (214) extends through the shaft from the proximal end to the distal end, and wherein the shaft comprises a first electrical conductor (210) extending from the proximal portion to the distal portion and electrically connectable to a radiofrequency generator (700); a radiofrequency puncture electrode (106) positioned to extend distally beyond the distal end and electrically connected to the first electrical conductor (paragraphs 0055, 0073, 0087, 0102 and 0115; Figures 2E and 8).
Referring to claims 2 and 3, Urbanski et al teaches wherein the shaft comprises a polymeric sleeve, and the first electrical conductor is in the form of a metallic hypotube received in the polymeric sleeve and wherein the polymeric sleeve is a high- density polyethylene sleeve and the metallic hypotube is a stainless steel hypotube (paragraphs 0055, 0092, 0097, 0100 and 0127).
Referring to claim 4, Urbanski et al teaches wherein the shaft comprises a polymeric inner layer and a polymeric outer layer, and the first electrical conductor is positioned between the polymeric inner layer and the polymeric outer layer (paragraphs 0055, 0092, 0097, 0100 and 0127).
Referring to claim 7, Urbanski et al teaches a second electrical conductor electrically connecting the electrode to the first electrical conductor (Figures 1, 2E and 8).
Referring to claim 11, Urbanski et al teaches wherein the radiofrequency puncture electrode is atraumatic (Figures 1, 2E and 8).
Referring to claim 12, Urbanski et al teaches a handle (110) at the proximal end of the shaft, wherein the first electrical conductor is electrically connectable to the radiofrequency generator via the handle (paragraph 0041).
Referring to claim 15, Urbanski et al teaches wherein the shaft is steerable (Figures 1, 2E and 8). It is noted that no specific steering components are recited.
Referring to claim 17, Urbanski et al teaches wherein the shaft comprises a radiopaque marker (paragraph 0121).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al (2014/0206987) as applied to the claim above, and further in view of Lee et al (2012/0089141).
Referring to claim 5, Urbanski et al teaches an inner and outer polymeric layer however fails to expressly teach the density. Lee et al teaches an analogous puncture device that uses both high- density polyethylene inner layer and low- density polyethylene outer layer to achieve various effects (paragraphs 0057, 0061, 0084, 0097, 0108, 0124 and 0162). 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 inner and outer polymeric layers, as taught by Urbanski et al, to have high- density polyethylene inner layer and low- density polyethylene outer layer, as taught by Lee et al, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 6, 8, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al (2014/0206987) as applied to the claim above, and further in view of Urbanski et al (WO/2019/215618) (hereinafter referred to as Urbanski2).
Referring to claim 6, Urbanski et al fails to teach that the first electrical conductor is in the form of a wire or a braid. Urbanski2 teaches an analogous puncture device wherein the first electrical conductor is in the form of a wire or a braid (paragraphs 00021, 0055, 0062-0063; Figure 3C). 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 first electrical conductor, as taught by Urbanski et al, to be a wire, as taught by Urbanski2, because it would have been an obvious matter of design choice to make the different portions of the electrical conductor be whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Referring to claim 8, Urbanski et al fails to teach that the second electrical conductor is in the form of a wire having a first end and a second end, wherein the first end is joined to the first electrical conductor, and the second end is spaced distally of the distal end and joined to the radiofrequency puncture electrode. Urbanski2 teaches an analogous puncture device comprising a second electrical conductor (guidewire 10) is in the form of a wire having a first end and a second end, wherein the first end is joined to the first electrical conductor (distal tip 10d), and the second end is spaced distally of the distal end and joined to the radiofrequency puncture electrode (paragraphs 00021, 0055, 0062-0063; Figure 3C). 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 puncture device, as taught by Urbanski et al, to have a second electrical conductor is in the form of a wire having a first end and a second end, wherein the first end is joined to the first electrical conductor, and the second end is spaced distally of the distal end and joined to the radiofrequency puncture electrode, as taught by Urbanski2, because the guidewire allows for advancement of the electrical conductor and electrode.
Referring to claim 14, Urbanski et al fails to teach wherein the shaft has an outer diameter of between about 12.5 Fr and about 24 Fr. Urbanski2 teaches wherein the shaft has an outer diameter of between about 12.5 Fr and about 24 Fr (paragraph 00096). 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 shaft, as taught by Urbanski et al, to be between about 12.5 Fr and about 24 Fr, as taught by Urbanski2, because it would have been an obvious matter of design choice since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Referring to claim 18, Urbanski et al fails to teach wherein the shaft comprises an echogenic marker. Urbanski2 teaches an analogous puncture device wherein the shaft comprises an echogenic marker (paragraph 00112). 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 shaft, as taught by Urbanski, to include a echogenic marker, as taught by Urbanski2, in order to be visible using ultrasound imaging systems (paragraph 00112).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al (2014/0206987) as applied to the claim above, and further in view of Kimmel et al (2013/0304036).
Referring to claim 18, Urbanski et al fails to teach wherein the handle comprises a hemostatic valve. Kimmel et al teaches an analogous surgical device wherein the handle comprises a hemostatic valve (48) (paragraphs 0064 and 0076; Figures 1, 11A and 11B). 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 handle, as taught by Urbanski, to include a hemostatic valve, as taught by Kimmel et al, in order to provide an air-tight seal (paragraph 0076).
Response to Arguments
Applicant's arguments filed December 11, 2025 have been fully considered but they are not persuasive. The examiner maintains that Urbanski et al teaches a radiofrequency puncture electrode (106) positioned to extend distally beyond the distal end and electrically connected to the first electrical conductor (paragraphs 0055, 0073, 0087, 0102 and 0115; Figures 2E and 8). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., not integral with or directly coupled with the distal end) are not recited in the rejected claim(s). 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).
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 SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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, Linda Dvorak can be reached at 571-272-4764. 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.
/SAMANTHA M GOOD/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794