Prosecution Insights
Last updated: October 02, 2026
Application No. 18/179,670

STYLET, SYSTEM INCLUDING STYLET, AND METHOD FOR CARRYING OUT MEDICAL PROCEDURE WITH STYLET

Final Rejection §103§112
Filed
Mar 07, 2023
Priority
Sep 10, 2020 — provisional 63/076,458 +1 more
Examiner
GUERRERO ROSARIO, ANA VERUSKA
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Boston Scientific Corporation
OA Round
4 (Final)
46%
Grant Probability
Moderate
5-6
OA Rounds
5m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
27 granted / 59 resolved
-24.2% vs TC avg
Strong +49% interview lift
Without
With
+49.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 12m
Avg Prosecution
39 currently pending
Career history
112
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
53.2%
+13.2% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
16.2%
-23.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 59 resolved cases

Office Action

§103 §112
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 June 19, 2026 have been entered. Applicant’s amendments have overcome the 112(d), the 112(b) rejections, and all the Double Patenting rejections previously set forth in the Non-Final Office Action mailed on 03/20/2026. Currently, claims 1-4, 7-8, 10-11, 13, 16, 19 have been amended, and claims 1-4 and 7-11, 13, 16-17, 19-20 are pending in the application. 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. Claims 1-4 and 7 are 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 1 recites the limitation "an introducer" in line 17. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this introducer is different from the introducer already previously cited in the claim, or if they are the same structure. For examination purposes, Examiner will treat both introducer as the same structure on the system for use in puncturing a pericardium of a patient's heart of claim 1. Claims 2-4 and 7 are also rejected because they are dependent on claim 1. 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. Claims 1-4, 7, 13, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Christian (U.S. Application No. 20140163548 A1). Regarding independent claim 1, and claim 7, Davies discloses a system for use in puncturing a pericardium (226) of a patient’s heart (Col. 2, lines 31-34), the system comprising: a stylet (100) (Col. 5, lines 42-46 & Figs. 1A, 1D) comprising: an elongate shaft (102) having a proximal portion (104) and a distal portion (108) (Col. 5, lines 42-46), wherein the shaft comprises a metallic body (122) (Col. 6, lines 14-15) and is rigid (Col. 16, lines 34-36), and wherein the distal portion defines a distal end that is blunt (see Fig. 1D); a radiofrequency puncture electrode (112) at the distal end of the shaft (Col. 5, lines 50-54; Col. 15, lines 32-33), wherein the radiofrequency puncture electrode is electrically connectable to a radiofrequency generator (not shown) (Col. 9, lines 8-12); and a hub (118) joined to the proximal portion of the shaft, wherein the hub is configured to electrically connect the metallic body to the radiofrequency generator, for delivery of radiofrequency energy along the metallic body from the proximal portion of the shaft to the radiofrequency puncture electrode (Col. 6, lines 8-10); wherein the elongate shaft includes a longitudinally extending lumen (120) coupled to a fluid port (distal portion of the lumen) disposed on the radiofrequency puncture electrode (Col. 6, lines 10-14 & Fig. 1D); and an introducer (224) comprising an elongate tube, the elongate tube comprising a lumen for receiving the stylet (Col. 8, lines 50-59; Col. 15, lines 66-67 – Col. 16, lines 1-3 & Figs. 5A-5D), wherein the elongate tube has an outer layer (outermost layer of the elongate tube) and a distal tip (distalmost portion of the elongate tube); and wherein the fluid port is disposed distal to the distal tip of the elongate tube (when the stylet is advanced from/extended beyond the elongate tube of the introducer, into the pericardium of the patient, as seen in Fig. 5D). However, Davies does not disclose the proximal portion of the elongate shaft includes a lock for securing the shaft to the introducer, nor wherein the elongate tube has an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form a distal tip. Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip. Furthermore, Appling teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039). Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure. However, Davies/Appling combination do not explicitly disclose the fluid port being disposed proximally to the radiofrequency puncture electrode, specifically, while the Davies reference provides for the fluid port to be at the distal end of the lumen, and further contemplates rearranging the location of the fluid port to be a side port/aperture, as described in Col. 12, lines 36-44, neither reference shows a fluid port that is disposed proximally to the radiofrequency puncture electrode. Christian, in the same field of endeavor, teaches an ablation electrode assembly (10) comprising an elongate catheter shaft (18) with an RF electrode (46) at its distal end (pa. 0033-0034 & Figs. 1, 3). The shaft comprises a fluid passageway (62) with a distal side port/shaping member (108) (pa. 0063) that helps ensure that the fluid flow tends toward the surface of the ablation electrode assembly (pa. 0043). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the fluid port of Davies to be located proximal to the puncture electrode, as taught by Christian, for the purpose allowing the user to indicate the specific location of the distal end of the stylet in order to indicate if the radiofrequency electrode has reached the target tissue (Davies, Col. 12, lines 36-44). Examiner emphasizes how the resultant modification of the location of the fluid port, as described above, would yield to a fluid port that is both disposed distal to the distal tip of the elongate tube and proximal to the radiofrequency electrode given that the distal portion and the distal end of the stylet, including the fluid port, are still capable of being advanced/extended beyond the distal tip of the elongate tube and into the pericardium of the patient's heart, as seen in Fig. 5D of Davies. Regarding claim 2, Davies/Appling/Christian combination discloses wherein the shaft comprises an electrically insulative material (116) on the metallic body (Davies, Col. 6, lines 3-5 & Fig. 1D). Regarding claim 3, Davies/Appling/Christian combination discloses wherein the radiofrequency puncture electrode comprises an electrically exposed tip (Davies, i.e., proximal portion of the electrode that is electrically connected to the metallic portion) of the metallic body. Regarding claim 4, Davies/Appling/Christian combination discloses wherein the radiofrequency puncture electrode comprises a metallic piece (i.e., the conductive material of the electrode) joined to the metallic body (Davies, Col. 6, lines 6-7). Examiner is highlighting the various techniques explicitly described in similar embodiments, such as welding and soldering methods, to electrically connect two conductive regions together to allow radiofrequency energy to flow from the metallic body to the electrode at the distal end of the shaft. Regarding independent claim 13, Davies discloses a method for puncturing a pericardium of a patient's heart (Col. 2, lines 31-34 & Figs. 1A-1D, and 5A-5D): positioning a stylet (100, 200) having a distal electrode (112, 212) (Col. 5, lines 50-54; Col. 15, lines 32-33) and a fluid port (distal portion of lumen 120) (Col. 6, lines 10-14 & Fig. 1D) in an introducer (224) such that the electrode extends beyond a distal end of the introducer (see Fig. 5D) and the fluid port is disposed on the distal electrode (see Fig. 1D) and is distal to the distal end of the introducer (in the configuration when the stylet is advanced from/extended beyond an elongate tube of the introducer, into the pericardium of the patient, as seen in Fig. 5D), the introducer comprising an elongate tube having a proximal portion and a distal tip (see Figs. 5A-5D); percutaneously advancing the stylet and the introducer towards the patient’s heart (Col. 8, lines 34-38 & Figs. 2A-2F); delivering radiofrequency energy from the distal electrode (112, 212) of the stylet to puncture the pericardium of the patient’s heart (Col. 9, lines 8-12). However, Davies does not disclose the proximal portion of the elongate tube having a first diameter and the distal tip of the elongate tube having a second diameter that is less than the first diameter, the elongate tube including an outer layer and an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip. Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip. Also seen in Fig. 2 is the distal tip including a tapered outer profile which aids in insertion and advancement of the sheath (pa. 0032), wherein a proximal portion of the sheath has a first diameter (approximately 0.079″), a distal portion of the sheath, including the distal tip has a second diameter (approximately 0.058″) that is less than the first diameter (pa. 0032). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039). However, Davies/Appling combination do not disclose the fluid port being disposed proximally to the distal electrode, specifically, while the Davies reference provides for the fluid port to be at the distal end of the lumen, and further contemplates rearranging the location of the fluid port to be a side port/aperture, as described in Col. 12, lines 36-44, neither reference shows a fluid port that is disposed proximal to the distal electrode. Christian, in the same field of endeavor, teaches an ablation electrode assembly (10) comprising an elongate catheter shaft (18) with an RF electrode (46) at its distal end (pa. 0033-0034 & Figs. 1, 3). The shaft comprises a fluid passageway (62) with a distal side port/shaping member (108) (pa. 0063) that helps ensure that the fluid flow tends toward the surface of the ablation electrode assembly (pa. 0043). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the fluid port of Davies to be located proximal to the puncture electrode, as taught by Christian, for the purpose allowing the user to indicate the specific location of the distal end of the stylet in order to indicate if the radiofrequency electrode has reached the target tissue (Davies, Col. 12, lines 36-44). Examiner emphasizes how the resultant modification of the location of the fluid port, as described above, would yield to a fluid port that is both disposed distal to the distal tip of the elongate tube and proximal to the distal electrode given that the distal portion and the distal end of the stylet, including the fluid port, are still capable of being advanced/extended beyond the distal tip of the elongate tube and into the pericardium of the patient's heart, as seen in Fig. 5D of Davies. Regarding claim 16, Davies/Appling/Christian combination discloses further comprising advancing a distal end of the stylet and the distal end of the introducer through the puncture (Davies, Col. 9, lines 33-37). Regarding claim 17, Davies/Appling/Christian combination discloses further comprising retracting the stylet from the introducer (Davies, Col. 14, lines 21-25). Regarding claim 19, Davies discloses the stylet (100, 200) configured to be inserted inside the introducer (Col. 8, lines 50-52 & Fig. 2C-2D). However, Davies does not disclose wherein during the positioning step, the stylet being locked to the introducer. Appling, in the same field of endeavor, teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath. Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure. Regarding claim 20, Davies/Appling/Christian combination discloses further comprising delivering a contrast agent through the stylet and out of a port (i.e., distal end of lumen 120) of the stylet (Davies, Col. 6, lines 10-14; Col. 8, lines 9-12). Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Patent No. 8702692 B2), in view of Christian (U.S. Application No. 20140163548 A1), in view of Appling (U.S. Application No. 20160106501 A1), and further in view of Wegrzyn (U.S. Application No. 20180036060 A1). Regarding independent claim 8, Davies discloses a system of medical devices for use in puncturing a pericardium (226) of a patient’s heart (Col. 2, lines 31-34 & Figs. 1A-1D, 5A-5D), the system comprising: a radiofrequency generator (not shown) (Col. 9, lines 8-12); a stylet (100) comprising (i) an elongate shaft (102) having a shaft proximal portion (104) and a shaft distal portion (108) defining a shaft distal end (Col. 5, lines 42-46 & Figs. 1A, 1D), wherein the shaft is rigid (Col. 16, lines 34-36), (ii) a radiofrequency puncture electrode (112) at the shaft distal end (Col. 5, lines 50-54; Col. 15, lines 32-33), wherein the radiofrequency puncture electrode is electrically connectable to the radiofrequency generator (Col. 9, lines 8-12); and (iii) a longitudinally extending lumen (120) coupled to a fluid port (distal portion of the lumen) disposed on the radiofrequency puncture electrode (Col. 6, lines 10-14 & Fig. 1D); and an introducer (224) comprising an elongate tube extending between a tube proximal portion and a tube distal portion defining a tube distal end (Col. 8, lines 50-59 & Fig. 5A-5D), wherein the shaft is receivable in the elongate tube with the electrode proud of the elongate tube distal end (see Figs. 5C-5D) and the fluid port is disposed distal to the elongate tube distal end and on the radiofrequency puncture electrode (when the stylet is advanced from/extended beyond the elongate tube of the introducer, into the pericardium of the patient, as seen in Fig. 5D); wherein the shaft is configured to be slidably received within the elongate tube; and wherein the elongate tube includes an outer layer (outermost layer of the elongate tube). However, Davies does not disclose the fluid port being disposed proximally to the radiofrequency puncture electrode, specifically, while the Davies reference provides for the fluid port to be at the distal end of the lumen, and further contemplates rearranging the location of the fluid port to be a side port/aperture, as described in Col. 12, lines 36-44, this reference does not show a fluid port that is disposed proximally to the radiofrequency puncture electrode. Christian, in the same field of endeavor, teaches an ablation electrode assembly (10) comprising an elongate catheter shaft (18) with an RF electrode (46) at its distal end (pa. 0033-0034 & Figs. 1, 3). The shaft comprises a fluid passageway (62) with a distal side port/shaping member (108) (pa. 0063) that helps ensure that the fluid flow tends toward the surface of the ablation electrode assembly (pa. 0043). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the fluid port of Davies to be located proximal to the puncture electrode, as taught by Christian, for the purpose allowing the user to indicate the specific location of the distal end of the stylet in order to indicate if the radiofrequency electrode has reached the target tissue (Davies, Col. 12, lines 36-44). Examiner emphasizes how the resultant modification of the location of the fluid port, as described above, would yield to a fluid port that is both disposed distal to the distal tip of the elongate tube and proximal to the radiofrequency electrode given that the distal portion and the distal end of the stylet, including the fluid port, are still capable of being advanced/extended beyond the distal tip of the elongate tube and into the pericardium of the patient's heart, as seen in Fig. 5D of Davies. However, Davies/Christian combination do not disclose the tube proximal portion having a first diameter, the tube distal portion, including a distal tip having a second diameter that is less than the first diameter, and wherein the elongate tube includes an inner reinforcing layer, the outer layer extending distally of the inner reinforcing layer to form the distal tip. Appling, in the same field of endeavor, teaches a sheath (1) (analogous to the introducer of Davies) comprising a shaft/outer layer (3), a lumen (4), a hub (2), and a distal tip (5) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material or other natural polymer material (pa. 0035) and is reinforced with a wire/inner reinforcing layer (8) that is embedded within the shaft/outer layer for the purpose of enhancing maneuverability during insertion and advancement through a target tissue (pa. 0039). As seen in Fig. 2, the shaft/outer layer extends distally of the wire/inner reinforcing layer to form the distal tip. Also seen in Fig. 2 is the distal tip including a tapered outer profile which aids in insertion and advancement of the sheath (pa. 0032), wherein a proximal portion of the sheath has a first diameter (approximately 0.079″), a distal portion of the sheath, including the distal tip has a second diameter (approximately 0.058″) that is less than the first diameter (pa. 0032). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling for the purpose of providing an introducer with a reinforced shaft that provides increased resistance to kinking during insertion and advancement (Appling, pa. 0039). However, Davies/Christian/Appling combination do not teach wherein the distal tip has a length of between 1 cm and about 4 cm. Wegrzyn, in the same field of endeavor, teaches a removable stylet (140) slidably received inside probe (100) (pa. 0060 & Figs. 1A-1C), wherein the probe comprises a distal tip (101) with a length of about 20mm (2cm) (pa. 0059). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the distal tip to be within the range of 1cm-4cm, as taught by Wegrzyn, for the purpose of properly penetrating the targeted tissue. Regarding claim 9, Davies/Christian/Appling/Wegrzyn combination discloses wherein the shaft distal end is blunt (Davies, see Fig. 1D). Regarding claim 10, Davies discloses the shaft being received in the elongate tube and the electrode proud of the elongate tube distal end (see Figs. 5A-5D). However, Davies/Christian/Wegrzyn combination do not disclose wherein the stylet is lockable to the introducer. Appling, in the same field of endeavor, teaches a dilator (17) (analogous to the stylet of Davies) which is inserted and advanced through the distal tip of the sheath (pa. 0032 & Figs. 5-6), wherein a proximal end of the dilator includes a male luer fitting (19) that creates a threaded connection with the dilator hub (pa. 0047, 0050); thereby, securing the dilator to the sheath. Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the luer connection lock taught by Appling to the system of Davies in order to provide further stabilization to the stylet when inserted into the introducer, as well as avoiding unwanted separation during a procedure. Regarding claim 11, Davies discloses the shaft comprising a metallic body (122) (Col. 6, lines 14-15), and the distal end of the introducer (224) is comprised of a compliant (yielding) material to further facilitate forming a seal with the parietal pericardium (801) (Col. 17, lines 15-17). However, Davies does not explicitly disclose the elongate tube comprises an electrically insulative material. Appling, in the same field of endeavor, teaches the sheath (1) comprises a shaft/outer layer (3) (pa. 0031 & Figs. 1-2), wherein the shaft/outer layer is comprised of a translucent material such as nylon or other natural polymer material such as Teflon or polyethylene (pa. 0035), and the distal tip includes an outer layer (16) also made from a translucent material (pa. 0033) in order to provide a smooth, low-friction outer surface during insertion, advancement and withdrawal of the device through the tissue (pa. 0034). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the introducer of Davies with the introducer taught by Appling, which includes the insulative materials, for the purpose of providing an introducer with a smooth, low-friction outer surface during insertion, advancement and withdrawal of the device through the tissue (Appling, pa. 0034). Response to Arguments Applicant's arguments filed 06/19/2026 have been fully considered but they are not persuasive. With regards to newly amended independent claims 1, 8, and 13, Applicant argues that the Christian reference does not teach the newly added language of the fluid port being disposed proximal to the radiofrequency puncture electrode and distal to the distal tip of the elongate tube as described in claim 1, or similarly the fluid port being disposed between the elongate tube distal end and the radiofrequency puncture electrode as described in claims 8 and 13. Specifically, Applicant contends that Christian does not teach an introducer, nor an elongate tube having an outer layer and inner reinforcing layer forming a distal tip, and no cross-component relationship between a fluid port and the distal tip of any coaxial tube. Additionally, Applicant explains that the reasoning for positioning the fluid port in this specific location is to allow a contrast agent to be delivered into the pericardial space directly adjacent to the electrode contact site, enabling positional confirmation under fluoroscopy immediately prior to and after RF puncture. However, Examiner respectfully, disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the Davies reference is utilized to disclose the introducer (224) comprising an elongate tube having a distal tip (distalmost portion of the elongate tube) (Col. 8, lines 50-59; Col. 15, lines 66-67 – Col. 16, lines 1-3 & Figs. 5A-5D), and a cross-component relationship between a fluid port (a distal portion of the lumen 120) that is disposed on the radiofrequency puncture electrode (Col. 6, lines 10-14 & Fig. 1D) and is distal to the distal tip of the elongate tube, specifically in the configuration when the stylet is advanced from/extended beyond the elongate tube of the introducer and into the pericardium of the patient (see Fig. 5D). The Christian reference is then utilized to teach an elongate catheter shaft (18) with an RF electrode (46) at its distal end (pa. 0033-0034 & Figs. 1, 3). The shaft comprises a fluid passageway (62) with a distal port/shaping member (108), proximal to the RF electrode, (pa. 0063) to ensure that the fluid flow tends toward the surface of the ablation electrode assembly (pa. 0043). Examiner emphasizes how the resultant modification of the location of the fluid port, as described above, would yield to a fluid port that is both disposed distal to the distal tip of the elongate tube and proximal to the radiofrequency electrode given that the distal portion and the distal end of the stylet, including the fluid port, are still capable of being advanced/extended beyond the distal tip of the elongate tube and into the pericardium of the patient's heart, as seen in Fig. 5D of Davies. Furthermore, the resultant modification would also reap the same functional benefits of aiding in positioning of the stylet prior and after an RF procedure. Therefore, for the reasonings set-forth above, the rejection based on the combination of references is maintained. 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 ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM 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. 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. /A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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Prosecution Timeline

Show 2 earlier events
Sep 15, 2025
Response Filed
Nov 17, 2025
Final Rejection mailed — §103, §112
Jan 16, 2026
Response after Non-Final Action
Feb 17, 2026
Request for Continued Examination
Mar 09, 2026
Response after Non-Final Action
Mar 20, 2026
Non-Final Rejection mailed — §103, §112
Jun 19, 2026
Response Filed
Aug 25, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
46%
Grant Probability
95%
With Interview (+49.3%)
3y 12m (~5m remaining)
Median Time to Grant
High
PTA Risk
Based on 59 resolved cases by this examiner. Grant probability derived from career allowance rate.

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