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 Arguments
Applicant's arguments filed 12/1/2025 have been fully considered but they are not persuasive.
Applicant argues the claims are not directed to an abstract idea because the human mine cannot be coupled to a lead located within a septal wall; nor can it be coupled to a monitor. The examiner notes that these are additional elements outside the abstract idea and are analyzed in step 2A prong two and Step 2B. The Applicant also argues that a surgeon cannot mentally obtain morphology data and compare the QRS width to a QRS width threshold; also it is unrealistic to expect the operating room to continually pause the procedure while someone uses paper and pencil to do this comparison. Therefore, the procedure cannot be accomplished in the mind. The examiner respectfully disagrees as a person having ordinary skill in the art is able to take a measurement or look at a printout of an ECG and compare it to a threshold. Furthermore, pausing a procedure is not unrealistic, and occurs in instances so that imaging can be acquired to verify device placement; this does not mean that the comparing a value to a threshold is not an abstract idea. Applicant argues the claims provide a specific improvement to the technical field of cardiac treatment, and to the technical field of systems that have a lead configured to be implanted within a septal wall to obtain cardiac activity at the implant location. The examiner respectfully disagrees as MPEP 2106.05(a)(II) identifies it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. The examiner notes that the claim as recited does not require a treatment. Additionally, the recited additional elements are recited at a high level of generality and the lead is a pre-solution activity with the monitor for gathering cardiac signals. The Applicant argues that the elements combine to form a system that improves the implantation procedure of leads located within a septal wall. The examiner respectfully disagrees as the claim requires a lead, monitor, memory and a processor used to compare the obtained QRS width to a threshold and does not recite further structure for controlling lead placement.
The Applicant argues that the claims improve the implant procedure and safety of the patient by addressing the complexities of determining when a lead being implanted in a septal wall is at a target depth. The examiner respectfully disagrees as the lead and monitor are well known routine and conventional and the claim does not recite additional elements to be significantly more than the judicial exception. Applicant argues Zhou does not teach a QRS threshold to identify any change between QRS widths 246 and 256 that would indicate the electrode 32 is positioned correctly. Applicant argues that if Zhou uses the relatively narrow and wide comparisons of the QRS width to determine when the lead is located at a target depth within the septal wall could result in incorrect positioning of the electrode 32. Therefore, the Applicant argues the prior art does not determine when the lead is located at a target depth within the septal wall. The examiner respectfully disagrees as the specifics of the “QRS threshold” are not claimed and does not preclude the prior arts use of QRS width for detecting placement. In addition, the target depth, in claims 2 and 14 of the instant application, is defined as the lead is proximate to the left bundle branch. Zhou discloses in Paragraph [0214] that 201c corresponds to a pacing tip electrode location that is approximately mid-way within the septum 12 which is proximate the LBB. Therefore, the arguments are not persuasive.
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 1-3, and 5-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) to a mental process of using cardiac activity signal and using the data to determine lead position. This judicial exception is not integrated into a practical application because the lead (an electrode of a leadless IMD) and monitor are pre-solution activities to obtain the cardiac signals and the memory and processors are generic computing devices to perform the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a lead (claim 12 an electrode of a leadless IMD) and a monitor configured to obtain cardiac activity signals are routine, well-known and conventional. In addition the use of memory and processor that executes the program on memory is part of generic computing devices (e.g. Paragraph [0072] of the instant published disclosure) The dependent claims further elaborate on the abstract idea and do not include an additional elements.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3. and 5-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al (US Publication 2022/0023640).
Referring to Claim 1, Zhou et al teaches a system, comprising: a lead configured to be located within a septal wall (e.g. Figure 1, lead 18 and Figure 3); a monitor configured to obtain cardiac activity signals (e.g. Figure 1, Element 50 and Paragraph [0137]); memory configured to store program instructions (e.g. Figure 1, memory 53 and Paragraph [0142]); one or more processors that, when executing the program instructions (e.g. Figure 1, Element 52), are configured to: obtain morphology data related to the cardiac activity signals indicative of the lead located at different depths within the septal wall, the morphology data including a set of data values associated with different depths of the lead within the septal wall (e.g. Paragraph [0144]), wherein the morphology data includes QRS width of consecutive heartbeats (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]); determine when the lead is located at a target depth within the septal wall based on a change in the QRS width from a first QRS width to a second QRS width that is greater than a QRS width threshold (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]).
Referring to Claim 2, Zhou et al teaches the system of claim 1, wherein the target depth locates the lead proximate to the left bundle branch (LBB) (e.g. Paragraphs [0204]-[0208]).
Referring to Claim 3, Zhou et al teaches the system of claim 1, wherein the one or more processors are configured to determine that the lead is located proximate the LBB based on a change in the QRS width from the first QRS width to the second QRS width (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]).
Referring to Claim 5, Zhou et al teaches the system of claim 1, wherein the first QRS width is obtained from a first heartbeat and the second QRS width is obtained from a second heartbeat, and the first heartbeat and second heartbeat are not consecutive heartbeats (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]).
Referring to Claim 6, Zhou et al teaches the system of claim 1, wherein the morphology data includes a peak-to-peak amplitude of consecutive heartbeats, and the one or more processors are further configured to determine that the lead is located proximate the LBB based on a change in a peak-to-peak amplitude value between a first peak-to-peak amplitude and a second peak-to-peak amplitude (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0234]-[0237]).
Referring to Claim 7, Zhou et al teaches the system of claim 6, wherein the change in peak-to-peak amplitude is greater than a threshold change between the first peak-to-peak amplitude and the second peak-to-peak amplitude (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 8, Zhou et al teaches the system of claim 1, wherein the determine operation includes determining when the data values indicate the change in the QRS width based on one or more of absolute change, percentage of change, or rate of change in the QRS width (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 9, Zhou et al teaches the system of claim 8, wherein the determine operation further comprises comparing the data values, within the set of data values, to one another to determine a relation; determining when the relation satisfies a criteria of interest (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 10, Zhou et al teaches the system of claim 1, wherein the determine operation further comprises comparing the data values, within the set of data values, to one another to determine a relation; and determine when the relation satisfies a criteria of interest, wherein the criteria of interest is a change in a peak-to-peak amplitude (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 11, Zhou et al teaches the system of claim 1, wherein the target depth includes a point where the lead is proximate the LBB and does not perforate a LV septum side wall distal wall of the septal wall (e.g. Figures 2A-2D, 5 and 6 and Paragraphs [0212]-[0214]).
Referring to Claim 12, Zhou et al teaches the system of claim 1, wherein the lead is a first electrode of a leadless IMD (e.g. Figure 3).
Referring to Claim 13, Zhou et al teaches a computer implemented method, wherein under control of one or more processors configured with specific executable instructions, the method comprises: obtaining morphology data indicative of a morphology of consecutive beats of a heart including a set of data values associated with different depths of a lead within the septal wall (e.g. Figure 1; Figure 5, Element 154 and Paragraph [0144]) , wherein the morphology data includes QRS width of consecutive heartbeats (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]); determining when the lead is located at a target depth within the septal wall based on a change in the QRS width from a first QRS width to a second QRS width that is greater than a QRS width threshold (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]).
Referring to Claim 14, Zhou et al teaches the method of claim 13 further comprising: determining that the lead is located proximate the LBB when the morphology data indicates the change in the QRS width is above the QRS width change threshold (e.g. Paragraphs [0220]-[0229] and [0232]).
Referring to Claim 15, Zhou et al teaches the method of claim 13, further comprising: determining that the lead is located proximate the LBB when the morphology data indicates a change in peak-to-peak amplitude is above a peak-to-peak amplitude change threshold (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0234]-[0237).
Referring to Claim 16, Zhou et al teaches the method of claim 13, wherein the determining operation includes determining when the data values indicate the change in the QRS width based on one or more of absolute change, percentage of change, or rate of change in the QRS width (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 17, Zhou et al teaches the method of claim 16, wherein the determining operation further comprises comparing the data values, within the set of data values, to one another to determine a relation; determining when the relation satisfies a criteria of interest (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 18, Zhou et al teaches the method of claim 13, wherein the determining operation further comprises comparing the data values, within the set of data values, to one another to determine a relation; and determining when the relation satisfies a criteria of interest, wherein the criteria of interest is a change in a peak-to-peak amplitude (e.g. Figure 6 and Paragraphs [0220]-[0229] and [0232]-[0237]).
Referring to Claim 19, Zhou et al teaches the method of claim 13, wherein the target depth includes a point where the lead is proximate the LBB and does not perforate a LV septum side wall distal wall of the septal wall (e.g. Figures 2A-2D, 5 and 6 and Paragraphs [0212]-[0214]).
Referring to Claim 20, Zhou et al teaches the method of claim 13, wherein obtaining morphology data indicative of the morphology of the consecutive beats of the heart comprises monitoring, with a monitor, the consecutive beats of the heart as the lead is inserted into the septal wall (e.g. Figures 2A-2D, 5 and 6 and Paragraphs [0212]-[0214]).
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM 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, David Hamaoui can be reached at (571)270-5625. 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.
/William J Levicky/Primary Examiner, Art Unit 3796