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 January 20th, 2026 has been entered. Applicant’s amendments to the claims have overcome the claim objections and 112(b) rejections previously set forth in the Non-Final Office Action mailed October 16th, 2025
Response to Arguments
In response to applicant's argument on page 7 that Kimmel discloses a procedure fundamentally different than a pericardial puncture, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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., “since transseptal and pericardial punctures differ significantly in surgical location, clinical intervention and thus device configuration, adapting the needle system disclosed by Kimmel for pericardial puncturing would require substantial redesign”, specifically structural features necessary for an invention’s configuration to be limited to pericardial puncture) 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).
In response to applicant's arguments against the references individually on pages 7-8, 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 instance, Kimmel teaches a needle puncture system comprising two electrodes coming into contact and Christopherson teaches an indicator system and an activatable indicator. The claim language recites that the indicator is “configured to be activated when the second indicator electrode is longitudinally aligned with the first indicator electrode” but does not specify that the indicator is not activated if there is mismatch between the longitudinal alignment, the degree of alignment required, or language to specify that it only illuminates when the puncture device is in a puncture position to puncture the pericardium.
Therefore, these arguments are not persuasive and the Examiner maintains that the current prior art of record teaches the original and amended claim limitations, as reflected in the updated rejection, below.
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 1-10 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.
Regarding claim 1, the claim recites “enables” in line 21 and it is unclear if this is meant to be interpreted as an active method step or a device function since this claim is interpreted as an apparatus claim. For examination purposes, the limitation will be interpreted as “is configured to enable”.
Claim 1 recites the limitation “the indicator” in line 22. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “the indicator” in line 22 and it is unclear what indicator this is referring to: the first indicator, the second indicator, the indicator system or a separate indicator. For examination purposes, the limitation will be interpreted as “the second indicator” until Applicant amends or clarifies.
Claims 2-10 are also rejected by virtue of their dependency 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel et al. (U.S. Pub. No. 20180070982, previously cited), herein referred to as “Kimmel” in view of Christopherson (U.S. Pub. No. 20050171522, previously cited), herein referred to as “Christopherson”.
Regarding claim 1, Kimmel discloses a system of medical devices (Abstract: An MR compatible RF transseptal needle system is provided), comprising:
an introducer (delivery tool 202) extending between an introducer proximal end (proximal end of delivery tool 202) and an introducer distal end (distal end of delivery tool 202), wherein the introducer has a lumen (inner lumen 204) extending therethrough from the introducer proximal end to the introducer distal end ([0057]: the inner lumen 204 of the delivery tool 202), and wherein the introducer comprises a first indicator electrode that faces radially inwardly toward the lumen ([0026] Those of skill in the art will appreciate that the elements of the LPMM could be switched so that the wiper element is incorporated into the delivery tool and the resistive strips are incorporated in to the needle);
a puncture device ([0056]: MR-RF transseptal needle cannula) extending from a puncture device proximal end (proximal end of MR-RF transseptal needle cannula/main cannula portion 102) to a puncture device distal end (distal end 100 of the MR-RF transseptal needle cannula/tip portion 101), wherein the puncture device comprises a radiofrequency puncture electrode at the puncture device distal end ([0056]: The cannula includes a tip portion 101 and a main cannula portion 102. The tip portion is made of a conductive material) and a second indicator electrode that is positioned proximal of the radiofrequency puncture electrode and that faces radially outwardly ([0026]: Those of skill in the art will appreciate that the elements of the LPMM could be switched so that the wiper element is incorporated into the delivery tool and the resistive strips are incorporated in to the needle), wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end to position the puncture device in a puncture position to puncture a pericardium in which the radiofrequency puncture electrode is proud of the introducer distal end ([0057]: FIG. 2 shows the distal section 200 of the MR-RF design that includes the transseptal needle and the delivery tool. The transseptal needle tip 201 is in the retracted position within the inner lumen 204 of the delivery tool 202; [0058]: FIG. 3 shows the distal section 300 of the MR-RF design that includes the transseptal needle and the delivery tool. The transseptal needle tip 301 is in the extended position within the inner lumen 304 of the delivery tool 302; wherein the device of Kimmel is capable of being positioned to puncture a pericardium) and in which the second indicator electrode is longitudinally aligned with the first indicator electrode ([0024]: The LPMM could be incorporated into the MR-RF transseptal needle system by placing the two resistive linear elements on the delivery tool handle. A conductive wire would be electrically connected to the proximal end of each element. The wiper element would then be placed on the handle of the needle. When the needle is inserted far enough into the delivery tool, the wiper element makes electrical contact with the resistive elements. This contact creates an electrical short between the two resistive elements and the impedance of the circuit formed by the elements and the wiper can be measured. As the needle is advanced, a greater portion (length) of the resistive elements is contained within the circuit formed by the elements and the wiper and the impedance of the circuit changes. When the needle retracts, a shorter length of the resistive elements is contained with the circuit and the change in impedance is reversed; [0026]: Those of skill in the art will appreciate that the elements of the LPMM could be switched so that the wiper element is incorporated into the delivery tool and the resistive strips are incorporated in to the needle);
wherein the radiofrequency puncture electrode being proud of the introducer distal end enables delivery of radiofrequency energy to puncture the pericardium ([0058]: The transseptal needle tip 301 is in the extended position within the inner lumen 304 of the delivery tool 302 … If the needle tip 301 is in contact with the septum, the energy will be burn the tissue, facilitating septal puncture; see Fig. 3 & wherein the device is capable of puncturing a pericardium);
wherein the indicator is configured to be advanced to indicate the puncture device is in the puncture position for puncturing the pericardium ([0024]: When the needle is inserted far enough into the delivery tool, the wiper element makes electrical contact with the resistive elements. This contact creates an electrical short between the two resistive elements and the impedance of the circuit formed by the elements and the wiper can be measured; [0058]: The transseptal needle tip 301 is in the extended position within the inner lumen 304 of the delivery tool 302 … the needle tip 301 comes into contact with the ring electrode 303 … If the needle tip 301 is in contact with the septum, the energy will be burn the tissue, facilitating septal puncture; see 112(b) section, above, where this is being interpreted as “the second indicator” & see Fig. 3, wherein the device is capable of puncturing a pericardium).
but Kimmel fails to disclose an indicator system electrically connectable to the first indicator electrode and the second indicator electrode and comprising an indicator that is configured to be activated when the second indicator electrode is longitudinally aligned with the first indicator electrode.
However, Christopherson discloses a medical system (Abstract: In general, the invention provides a transurethral ablation device for indicating whether the ablation needle or needles are deployed or retracted during transurethral prostate treatment), comprising:
wherein the introducer comprises a first indicator electrode (needle position sensor 55; [0040]: needle position sensor 55 is located to make an electrical connection with needle 19 or conductive tube 54) that faces radially inwardly toward the lumen ([0038]: a needle position sensor 55 is located at the distal end 21 of catheter 19);
a second indicator electrode (conductive tube 54; [0040]: needle position sensor 55 is located to make an electrical connection with needle 19 or conductive tube 54) that is positioned proximal of the radiofrequency puncture electrode (ablation needle 19) and that faces radially outwardly (see Fig. 3A);
wherein the puncture device is advanceable through the lumen from the introducer proximal end towards the introducer distal end and in which the second indicator electrode is longitudinally aligned with the first indicator electrode ([0040]: needle position sensor 55 is located to make an electrical connection with needle 19 or conductive tube 54 when needle 19 is fully retracted);
an indicator system (needle position indicators 24 or 26) electrically connectable to the first indicator electrode and the second indicator electrode and comprising an indicator that is activated when the second indicator electrode is longitudinally aligned with the first indicator electrode ([0040]: When the contact 57 and the needle 19 or the conductive tube 54 come into contact, a current (i.e., the needle position signal 59) is produced in connector 67 which is received by a controller 60 (see FIG. 4). This current is indicative of a fully retracted needle. When the signal is received, the controller 60 outputs a control signal to needle position indicators 24, 26, 27 to indicate and confirm to the user that the needle is fully retracted).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Kimmel to include an indicator system, as taught by Christopherson, for the purpose of alerting a physician as to whether the needles are deployed or retracted during the course of the ablation procedure, producing an advisory when the needles are not fully retracted, reducing or eliminating the risk of repositioning the ablation needles without first fully retracting them and enabling the procedure to be easier and more efficient for the physician to perform (Kimmel: [0009]).
Regarding claim 2, Kimmel in view of Christopherson discloses wherein the indicator comprises a light, and activation of an indicator comprises the illumination of the light (Christopherson: [0010]: The position indicator can include audible tones, alarms, and/or visual indicators such as lights, colored lights, flashing lights, graphical images or text messages, each of which may provide the physician with an advisory or warning prior to attempting to reposition the ablation needles).
Regarding claim 3, Kimmel in view of Christopherson discloses wherein when the second indicator electrode is longitudinally aligned with the first indicator electrode, the second indicator electrode is in electrical contact with the first indicator electrode (Kimmel: [0024]: When the needle is inserted far enough into the delivery tool, the wiper element makes electrical contact with the resistive elements. This contact creates an electrical short between the two resistive elements and the impedance of the circuit formed by the elements and the wiper can be measured; [0026]: Those of skill in the art will appreciate that the elements of the LPMM could be switched so that the wiper element is incorporated into the delivery tool and the resistive strips are incorporated in to the needle; Christopherson: [0041]: needle position sensor 55 may include an object carried by the needle 19, the conductive sleeve 54, or the non-conductive tube 56 that mechanically engages, optically interrupts, magnetically, resistively or capacitively interacts with a sensor to determine the position of the needle 19. Needle position sensor 55 may, for example, be a mechanical or electrical sensor in which contacts open and close in response to movement of needle 19, conductive sleeve 54 or non-conductive tube 56 to thereby sense the needle position).
Regarding claim 4, Kimmel in view of Christopherson discloses wherein electrical contact of the first indicator electrode and the second indicator electrode is configured to complete an electrical circuit of the indicator system and thereby is configured to activate the indicator (Kimmel: [0024]: When the needle is inserted far enough into the delivery tool, the wiper element makes electrical contact with the resistive elements. This contact creates an electrical short between the two resistive elements and the impedance of the circuit formed by the elements and the wiper can be measured; [0026]: Those of skill in the art will appreciate that the elements of the LPMM could be switched so that the wiper element is incorporated into the delivery tool and the resistive strips are incorporated in to the needle; Christopherson: [0041]: needle position sensor 55 may include an object carried by the needle 19, the conductive sleeve 54, or the non-conductive tube 56 that mechanically engages, optically interrupts, magnetically, resistively or capacitively interacts with a sensor to determine the position of the needle 19. Needle position sensor 55 may, for example, be a mechanical or electrical sensor in which contacts open and close in response to movement of needle 19, conductive sleeve 54 or non-conductive tube 56 to thereby sense the needle position).
Regarding claim 5, Kimmel in view of Christopherson discloses wherein the indicator system comprises a first impedance sensor for sensing an impedance of the first indicator electrode (Christopherson: needle position sensor 55; [0041]: Needle position sensor 55 may be realized by any of a variety of position sensors, including mechanical sensors, electrical sensors, magnetic sensors, optical sensors, resistive sensors, capacitive sensors, or other appropriate sensors known to those of skill in the art) and a second impedance sensor for sensing an impedance of the second indicator electrode ([0041]: needle position sensor 55 may include an object carried by the needle 19, the conductive sleeve 54, or the non-conductive tube 56 that mechanically engages, optically interrupts, magnetically, resistively or capacitively interacts with a sensor to determine the position of the needle 19; wherein absent a specific sensor type or processor configured to measure an impedance, this is seen as a second impedance sensor if the resistance interaction with a sensor induces a change in resistance).
Regarding claim 6, Kimmel in view of Christopherson discloses wherein when the second indicator electrode is in contact with the first indicator electrode, the impedance of the first impedance sensor is configured to approximate the impedance of the second impedance sensor (Christopherson: [0041]: needle position sensor 55 may include an object carried by the needle 19, the conductive sleeve 54, or the non-conductive tube 56 that mechanically engages, optically interrupts, magnetically, resistively or capacitively interacts with a sensor to determine the position of the needle 19).
Regarding claim 7, Kimmel in view of Christopherson discloses wherein the indicator is activated when the impedance of the first impedance sensor approximates the impedance of the second impedance sensor (Christopherson: [0041]: needle position sensor 55 may include an object carried by the needle 19, the conductive sleeve 54, or the non-conductive tube 56 that mechanically engages, optically interrupts, magnetically, resistively or capacitively interacts with a sensor to determine the position of the needle 19; [0042]: As described above with respect to FIGS. 2B and 2C, the voltages carried by needle position signal 59 can be calibrated with known measurements of needle deployment and placed in a lookup table for reference by a controller. The controller can process the needle position signal 59 and refer to the lookup table to obtain the corresponding needle position … The appropriate needle position may then be displayed by position indicators 24, 26, 27).
Regarding claim 8, Kimmel in view of Christopherson discloses wherein the indicator system is built into the puncture device or the introducer (Christopherson: [0031]: needle position indicators 24 located on the handle 14).
Regarding claim 9, Kimmel in view of Christopherson discloses wherein the introducer comprises a hub at the introducer proximal end, and the indicator is provided on the hub (Christopherson: [0031]: needle position indicators 24 located on the handle 14).
Regarding claim 10, Kimmel in view of Christopherson discloses a radiofrequency generator electrically connectable to the radiofrequency puncture electrode, wherein the indicator system and the radiofrequency generator are an all-in-one unit (Kimmel: [0058]: In the extended position, the needle tip 301 comes into contact with the ring electrode 303. The first 305 and second 306 conduction lines are connected to the ring electrode 303. When energy is applied to the conduction lines 305 306, it is transferred into the ring electrode 303 and then further transferred to the needle tip 301. If the needle tip 301 is in contact with the septum, the energy will be burn the tissue, facilitating septal puncture; Christopherson: [0043]: FIG. 4 is a block diagram showing the relationship between the ablation energy generator 30, the needle position sensors 23, 25, and the needle position indicators 24, 26, 27. In this embodiment, ablation energy generator 30 includes a controller 60 which receives and processes needle position signals 53, 59 received from needle position sensors 23, 25, respectively).
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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794