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 Arguments
Applicant's arguments filed 04/202026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the rejections under 35 U.S.C. § 101 is on page 5 last paragraph through page 6 first full paragraph. First Applicant asserts:
“The rejection asserts in generalized terms that the claims are directed to an abstract idea and that the recited display and processor are generic, but it does not provide a claim-specific analysis identifying the alleged judicial exception for each rejected claim, nor does it explain why the claims, considered as a whole, fail to integrate any alleged exception into a practical application. Office Action, pp. 2-3.”
The examiner followed the § 101 analysis dictated by USPTO and found in Section 2103 through 2106.07 of the Manual of Patent Examination Procedure (MPEP). This practice has been in place for about a decade, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014), Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). Reciting a claimed invention that that is directed to – at least in part - an abstract idea (something that can be carried out by the human mind and/or with pen and paper) with a generic display and a generic processor does not allow for the “alleged exception into a practical application.”
Next Applicant asserts “The rejection also states that the display and processor are well-understood, routine, and/or conventional, but does not cite supporting evidence,” (omitted internal quotation marks). The examiner disagrees as the use of a generic display and generic processor are extremely well known in the art and have been so for many years. Additionally, the prior art rejections use both a display and a processor and serve as supporting evidence.
In response to Applicant’s assertions/remarks on page 6, 1st full paragraph, unfortunately the amendments to claim 1 do not overcome the § 101 – eligibility rejections.
Next, on page 6, the 3rd full paragraph Applicant asserts “Claim 1, as amended, recites in part, a processor, which is configured to ... present the entrance location to a user for penetrating the septum therein, wherein the display is configured to present, overlaid on an intra-procedural image of the heart, a cone of acceptance indicating a tolerance for placement of a distal end of the probe. Ben-Haim does not disclose all of the claimed limitations.” (internal quotation marks have been omitted, while the claim language is italicized). The examiner strongly disagrees since [0387]-[0388] and figure 13C of the prior art disclose otherwise as noted in the rejections below.
Applicant’s remarks traversing the § 103 – obviousness rejections on page 6, the last four paragraphs are unpersuasive as the rely on the previous traversing arguments regarding the anticipation rejection(s) that were shown to be unpersuasive. See the rebuttals above.
Applicant is invited to request an interview to discuss suggestions to find an acceptable conclusion of the prosecution for all parties.
Accordingly, this action is made FINAL.
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 therefore, 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.
The amendments to the claim 1 (and therefore also the amendments to claims 5-12) do not overcome the § 101 rejections.
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, Ben-Haim et al. 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 to reach the target anatomical location via the septum (see [0023] and figures 13C-14);
identify, based on the trajectory (one or more of the trajectories 1330, see [0387] and figure 13C), over the septum an entrance location for the probe to cross the septum and reach the target anatomical location; and
present the entrance location to a user for penetrating the septum therein, wherein the display is configured to present, overlaid on an intra-procedural image of the heart, a cone of acceptance (the cone defined by the collection of trajectories 1330 in figure 13C, see [0387] and figure 13C) indicating a tolerance for placement of a distal end of the probe.
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]-[0l 75], and [0320].
Regarding claim 5, Ben-Haim et al. disclose the claimed invention, see [0012], and
[03 83].
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],
[013 l], 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-Hiam 1 show 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.
Claims 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.
Applicant did NOT specifically traverse the Official Notice rejection, therefore, the Official Notice rejection is taken as admitted prior art.
Therefore, at the time of the 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 (and admitted prior art), to target the ostium of the LSPV in order to achieve PV isolation.
Conclusion
THIS ACTION IS MADE FINAL. 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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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, Niketa Patel can be reached at (571) 272-4156. 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.
/AARON F ROANE/Primary Examiner, Art Unit 3792
Prosecution Insights