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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 10/30/2025 is acknowledged.
Claims 13-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, and 5-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. This judicial exception is not integrated into a practical application because the generically recited display and/or processor elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computerized system having a display and a processor. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because both the display and processor have been recited to carry out well-understood, routine, and/or conventionally known functional limitations.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ben-Haim et al. (U.S. Patent Application Publication 2023/0044012).
Regarding claim 1, disclose a system comprising:
a display (“display,” see [0012], configured to present a rendering of at least part of a septum and a left atrium of a heart of a patient (see [0012], [0308]-[0310] and figures 13A-13B); and
a processor (“computer processor” or simply “processor,” [0012], [0025], [0069], [0314] for example), which is configured to:
identify in the rendering (i) the septum and (ii) a target anatomical location to be reached by a probe via the septum (see [0012], [0308]-[0310] and figures 13A-13B);
calculate a trajectory for the probe between the septum and the target anatomical location, including identifying over the septum an entrance location for the probe to cross the septum and reach the target anatomical location (see [0012], [0308]-[0310] and figures 13A-13B); and
present the entrance location to a user for penetrating the septum therein (see [0012], [0308]-[0310], [0313] and figures 13A-13B).
Regarding claim 2, Ben-Haim et al. disclose the claimed invention, see [0178] and [0361] for example.
Regarding claim 3, Ben-Haim et al. disclose the claimed invention, see [0160], and [0208]-[0209].
Regarding claim 4, Ben-Haim et al. disclose the claimed invention including that guidewire, see [0174]-[0175], and [0320].
Regarding claim 5, Ben-Haim et al. disclose the claimed invention, see [0012], and [0383].
Regarding claim 6, Ben-Haim et al. disclose the claimed invention, see [0012], and figures 5A-5C and 13A-13B.
Regarding claims 7-8, Ben-Haim et al. disclose the claimed invention, see [0291] and figures 13A-13B..
Regarding claim 10, Ben-Haim et al. disclose the claimed invention, see [0010], [0131], and [0174] for example.
Regarding claim 12, Ben-Haim et al. disclose the claimed invention, see figures 13A-13C.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (U.S. Patent Application Publication 2023/0044012) (Ben-Hiam 1) as applied to claim 1 above, and further in view of Ben-Haim et al. (U.S. Patent 6,892,091) (Ben-Hiam 2).
Regarding claim 9, Ben-Haim 1show the invention above,
but fail to recite the processor is further configured to identify a position and orientation of a distal end of the probe by using a sensor fitted on the distal end of the probe.
Like Ben-Haim 1, Ben-Haim 2 discloses a heart/cardiac treatment system and method, wherein the system has a catheter (“catheter 20”), processor (“computer 36 (as a signal processor)”) and teaches;
“Distal end 22 of catheter 20 further includes at least one location sensor 28 that generates signals used to determine the position and orientation of the catheter within the body. Location sensor 28 is preferably adjacent to distal tip 26 of catheter 20. There is preferably a fixed positional and orientational relationship of location sensor 28, tip 26 and electrode 24.”
See col. 7:64 – col. 8:4 and figures 1-7B.
This teaching provides a sensor at the distal end of the catheter/probe that helps the processor determine/identify the position/location and orientation of the distal end of the catheter/probe in order to provide the system with a known and workable manner of providing the position/location and orientation of the distal end of the catheter/probe in order to treat the heart.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Ben-Haim 1, as taught by Ben-Haim 2, to provide the system with a known and workable manner of providing the position/location and orientation of the distal end of the catheter/probe in order to treat the heart.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim et al. (U.S. Patent Application Publication 2023/0044012) as applied to claim 1 above, and further in view of Warnking (U.S. Patent Application Publication 2021/0267627).
Regarding claim 11, Ben-Haim et al. disclose the invention above,
but fail to recite the target anatomical location is an ostium of a superior left pulmonary vein (LSPV).
Like Ben-Haim et al., Warnking discloses a transeptal heart/cardiac treatment system and method and teaches:
“The ability to control orientation of the distal end of needle 5 enables identification of target areas such as Left Superior Pulmonary Vein (LSPV) 10 (FIG. 3) for PV isolation procedures and mitral valve (MV) 9 for repair or replacement thereof, and the appendage in case of appendage closures.”
See [0042].
This teaching provides that the lspv is the target in order to treat the heart in a known and workable manner.
What is still missing is a teaching that the target is more specifically the ostium of the LSPV and not just the LSPV. However, the examiner takes official notice of the recitation of ostium of the LSPV since it is extremely well known in the art to target the ostium of pulmonary vein when pulmonary vein isolation is desired.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Ben-Haim et al., as taught by Warnking, to target the LSPV in order to treat the heart transeptally, and further well known and taken official notice of, to target the ostium of the LSPV in order to achieve PV isolation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792