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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 13, 2025 has been entered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “703A” has been used to designate two different dedicated pins/plugs in Fig. 4 in contrast to pins/plugs 703B, 703C and 703D which supposedly allow one-to-one connection to sensors 203B, 203C and 203D respectively (like comments apply to Figs. 6 and 8). Element 705 designates both a pin in a second pin grouping, and a pin in a separate third pin grouping. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,793,446 in view of Schmit et al. (Pat. No. 9,522,048).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are, for the most part, merely broader in scope than the patented claims. For application of the Schmit reference to the above claim set with regards to the newly added limitations, see the rejection under §103 below.
Regarding claims 13 and 14, Official Notice was taken that it was old and well-known to utilize such a feature in order to allow one to conveniently maneuver the sheath to a desired location within the heart. Such a feature permits precise positioning of the apparatus for mapping and ablation of targeted tissues. Notice was also taken that the commercially available Carto ® electromagnetic guidance system referenced by the applicant (par. 0038 of the present specification) was known to have such steering mechanisms on the handle. To include such a feature on the handle of the ‘446 invention would have therefore been considered obvious to anyone desiring controlled maneuvering and positioning. The use of a conductor cable in the handle is also considered old and well-known as a means to allow convenient connection of sensors to external monitoring equipment. Lacking effective traversal, these features are now considered admitted prior art.
Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,793,446 in view of Moak et al. (Moak: Pub. No. 2020/0008883) and Schmit et al. (Pat. No. 9,522,048).
Regarding claim 10, while claim 5 of the ‘446 patent do not explicitly recite a mapping cable split into multiple conductors each having a dedicated pin electrically connected to at least one sensor, the use of such a structural arrangement is old and well-known in the art. Such an arrangement allows for a slimmer catheter profile, while allowing each sensor/electrode to be conveniently and independently connected to an interface device or electroanatomical mapping system as shown by Moak (see Fig. 3). Application of Schmit is discussed below in the rejection under §103.
Claims 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,793,446 in view of Schmit et al. and Chandrasekaran et al. (Chandresekaran: Pat. No. 6,638,222).
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are, for the most part, merely broader in scope than the patented claims. Regarding new claim 18, dependent claim 17, and the material pertaining to the use of a commutator, see the obviousness rejection below for further details including the pertinence of Chandresekaran, as well as Schmit for its signal-interface assembly. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Reference to the second grouping of receiver groupings configured to electrically connect to that at least one sensor and the distal energy emitter is not found in the original disclosure. While the applicant refers the examiner to specific pars. 0039, 0052 and 0053, none of these paragraphs discloses such an arrangement. Par. 0039, for example, merely states that the signal-interface assembly 901 is configured to receive signals from the sensors and the energy delivery assembly, and that the sheath sensors and dilator sensor are configured to be detectable via the signal interface assembly. There is no mention that the second grouping is configured to electrically connect to the at least one sensor and the distal energy emitter 208. Similar comments apply to pars. 0052 and 0053. The applicant is specifically requested to reference the exact sentence(s) which supports this limitation, and why the limitation is considered to be supported in the referenced sentence(s). Fig. 4 is reproduced below for convenience showing the various groupings (marked by the examiner in accordance with the applicant’s disclosure) disclosed by the applicant. Reference to Figure 4 in any response by the applicant would be helpful.
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Figs. 4, 6 and 8 show several pin/plug groupings, but their functioning in unclear. The specification indicates that the pins of the first and second groupings are connected to signal-interface assembly 901 (par. 0052). Paragraph 0053 indicates that pins 705 and 708 (in the third grouping) are also connected to the signal-interface assembly so as to convey signals to mapping system 900. If pins 703A-703D (first grouping) and 705 (second grouping) are already connected to the signal-interface assembly, then it is unclear what function pin 705 of the third grouping performs. Does the 705 pin of the second grouping function independently of the 705 pin of the third grouping? If so, there does not appear to be an adequate explanation as to how the pins function. If not, then one of the pins 705 would be redundant. It is also not known what function pin 524 performs. The applicant simply refers to it as a “dedicated conductor” without further explanation. It is further noted that while there are only five sensors shown (203A-203D and 205), and only five inputs 905 shown, the first and second groupings of pins number ten, making the function of the extra pins unclear.
It is unclear what the functioning of conductor 514 is compared to that of conductors 508 or 510, if the latter conductors already function to supply the energy emitter 208 with energy. The applicant states that pin 708 applies the energy signal from the energy generator 214 to the signal-interface assembly through cable 514, but it is unclear what purpose this serves since the energy signal is supplied to the distal energy emitter through conductors 508 and 510 from unit 214 and not from the signal-interface unit 901. It is unclear if the third grouping was intended to represent control lines for selecting particular sensors and for control of the energy emitter. There appears to be no discussion of such control, however.
The applicant in Fig. 2 shows a set of sensor wires 216 connected to respective sheath sensors and to the dilator sensor 205 (par. 0035), but then shows in the same figure energy generator 214 being connected to one of the sensor wires. If the energy generator is intended to apply energy to distal tip emitter 208, then it is unclear how this is accomplished since there is no connection to element 208 –only the sensors.
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 15 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.
The reference to the stationary element lacks antecedent basis.
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(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moak in view of Schmit et al. (Schmit: Pat. No. 9,522,048).
Regarding claim 1, Moak discloses an energy delivery assembly for transseptal puncture (par. 0004) adapted for use with an electroanatomical mapping system (pars. 0001, 0027), the assembly comprising: a medical sheath 110 having a dilator lumen; a medical dilator 120 configured to advance through the dilator lumen of the medical sheath, the medical dilator having a puncture device lumen (Figs. 1, 2, 4; par. 0005); an energy puncture device 135 having a distal portion including a distal energy emitter configured to be detectable by the electroanatomical mapping system (pars. 0026-0028), the puncture device configured to advance through the puncture device lumen (par. 0026); at least one sensor (elements 140) coupled to at least one of the medical sheath and the medical dilator such that the distal energy emitter and said at least one sensor are movable relative to each other (Figs. 1, 2 and 4; par. 0023); and a signal-interface assembly including a signal-input section (that section of the electroanatomical mapping system (e.g., Carto ®) into which at least elements 145, 147 (Fig. 3) are plugged along with any pre-processing circuitry such as requisite A/D converters, filters, etc.) configured to be operably coupled to said at least one sensor, and a signal-output section (that section of the mapping system which is inherently required to convey the received pre-processed signals to the processing circuitry) configured to be operably coupled to an input section of the electroanatomical mapping system; wherein the electroanatomical mapping system is configured to operably couple to the signal-interface assembly and to display spatial positions of the at least one sensor and the distal energy emitter (pars. 0027, 0033).
Regarding the newly added claim limitations pertaining to the use of a signal-interface assembly with an output section having a plurality of receivers arranged in a plurality of groupings electrically connected to at least one sensor and a distal energy emitter, the applicant gives no criticality in such an arrangement, and in fact, states that any equivalent signal-interface arrangement is suitable to the invention (par. 0039).
Schmit discloses an equivalent signal-interface assembly (214/204) for use in a related medical mapping system, including a housing (input module, see Fig. 2), a signal input section (see Fig. 2 and the plurality of numbered input receivers, i.e., any of the openings allowing connection of electrode pins associated with catheter 202) that are arranged in groupings (one can arbitrarily divide the receivers into groupings). The input receivers are designed to electrically connect to at least one sensor/electrode on catheter 202, and a distal energy emitter (any stimulation electrode on catheter 202 connected to stimulator 206 via the signal-interface 214/204). As stated, the arrangement of groupings is arbitrary. One can, for example, designate receiver inputs 1-16 as a first grouping which electrically connects to at least one sensor/electrode, and receiver inputs 17-32 combined with the receiver inputs labeled “Direct stimulator connection” as a second grouping which electrically connects with at least one sensor/electrode and a distal energy emitter, in order to satisfy the claim requirements. The signal output section is operably coupled to an input section of the electroanatomical mapping system (that section electrically connected to mapping CPU 208). Schmit further shows that such signal-interfaces old and well-known by artisans of ordinary skill in the electroanatomical mapping art, and teaches that such means help to ensure proper connection of all leads/catheters/electrodes to associated recording and mapping devices (see Background/Summary of Schmit). To utilize such a well-known means to ensure proper connection of cables to the mapping system would have therefore been considered readily obvious.
Regarding claim 2, see pars. 0026 and 0028.
Regarding claims 3 and 4, see Figs. 2 and 4.
Regarding claim 5, see par. 0006 (radiofrequency puncturing).
Regarding claims 6-8, see pars. 0025 where an imaging system such as the Carto ® inherently has a display, as well as the comments above with regards to Boveja and Govari.
Regarding claim 9, see par. 0027.
Regarding claim 10, see Fig. 3 where at least elements 147a-c are dedicated pins electrically connected to at least one sensor through multiple conductors 145a-c and configured to interface with a signal-interface assembly.
Regarding claim 11, the Carto ® electroanatomical mapping system is an imaging system inherently requiring a display device to enable visualization of aspects of the energy-delivery assembly (par. 0025).
Regarding claim 12, see Figs. 2 and 4.
Regarding claim 13 and the use of a handle having a steering adjustment knob for steering a medical sheath, Official Notice was taken that it was old and well-known to utilize such a feature in order to allow one to conveniently maneuver the sheath to a desired location within the heart. Such a feature permits precise positioning of the apparatus for mapping and ablation of targeted tissues. Notice was also taken that the Carto ® electromagnetic guidance system referenced by Moak and also by the applicant (par. 0038 of the present specification) is known to have such steering mechanisms on the handle. Lacking effective traversal, said features are now considered admitted prior art.
Regarding claim 14, see Fig. 3, where elements 132 135, 137 respectively represent a handle with a cable adapted to operably couple with the signal-interface assembly.
Regarding claim 15, as best as can be understood (note the rejection of said claim under §112 above), element 132 (Fig. 3) is considered a stationary handle extension.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moak et al. (Moak: Pub. No. 2020/0008883) in view of Schmit et al. as applied to claims 1-15 above, and further in view of Anderson et al. (Pub. No. 2008/0262431).
Regarding claim 16, while Moak does not explicitly state that the relative movement between the medical dilator and the medical sheath includes rotation of the dilator relative to the sheath, the fact that the dilator and sheath are cylindrical and designed to move relative to one another would reasonably imply that one could rotate the dilator with respect to the sheath, as would be typical for any like arrangement of tubular members. Clearly there is no impetus or need recited in the Moak reference to prevent relative rotation between the two components –if anything, the fact that the sensor electrodes 140 are disposed on one side of the dilator and sheath would suggest the desirability of allowing relative rotation to permit the electrodes to be better positioned with respect to the target site. In any event, Anderson is additionally cited for its teaching that in related dilator/sheath arrangements, the two components may rotate relative to one another (par. 0134).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moak et al. and Schmit et al. as applied to claims 1-15 above, and further in view of Chandrasekaran et al. (Chandresekaran: Pat. No. 6,638,222).
Regarding new claim 18, Moak does not discuss the recited electrical commutator device. Moak instead includes separate cables (wire(s) 145). The applicant discloses that those of ordinary skill in the art would appreciate that alternative embodiments to the commutator device may be utilized, including an arrangement that includes a separate cable (wire) added for the dilator sensor, without the electrical commutator device (par. 0066). The examiner agrees. Chandrasekaran discloses in a related medical device the use of a commutator (slip ring coupler; Fig. 2) that allows electrical connection to be maintained between the proximal handle end of the device and electrically driven elements on a distal rotatable catheter tip (col. 4, lines 9-28). The applicant gives no criticality whatsoever to the use of an electrical commutator. Clearly, any arrangement allowing for the requisite electrical connection to be established from the proximal handle end to the distal end components (e.g., the sensors) would have been suitable to the invention and thus the use of a commutator –a device by definition employed to form an electrical connection— would have been blatantly obvious to those of ordinary skill in the art desiring to establish electrical communication to at least the sensor components.
Regarding claim 17, note the comments above pertaining to the obviousness of including an electrical commutator. Rings and contacts –which allow relative rotation between circuit elements-- are the basic components of any commutator device and thus are inherently required. It is further noted that the applicant states that any equivalent to rings and contacts may be used (par. 0066). Thus, any electrical connection means to form the commutator would have been considered blatantly obvious. Chandrasekaran further discloses the use of a slip ring in combination with a spring contact (i.e., a ring and a contact) in a related device.
Response to Arguments
Applicant's arguments filed August 13, 2025 have been fully considered but they are not persuasive.
The amendment was not considered sufficient to saliently distinguish over the the related ‘446 patent with respect to obviousness-type double patenting. Note the detailed comments made above regarding the newly added claim limitations.
Regarding the rejection under §103, the applicant asserts that the newly added limitations are not found or made obvious in the prior art of record. It is argued that Moak merely teaches a plug corresponding with each distal end component and dangling from a proximal end of the assembly.
While it is agreed that Moak is silent as to the use of the signal-interface assembly as now claimed, the examiner disagrees that the recited limitations are not to be found in the prior art and directs the applicant’s attention to the detailed commentary above including the examiner’s explanation of the Schmit reference which is considered to read on the new limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited references include subject matter pertinent to the claimed signal-interface assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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, David E. Hamaoui can be reached on 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
January 23, 2026