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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in European Patent Office on April 05, 2024. It is noted, however, that applicant has not filed a certified copy of the EP 241688696 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “switch”, “fixing portion”, “a stylet”, “remote monitoring system” must be shown or the feature(s) canceled from the claim(s). Additionally, there is no “first pole” (in claim 5) shown in the drawing, “deformation” in claim 15, “helical curve”, and “a brady parameter screen and/or a follow-up screen” for display is also not shown in the drawing. No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “switch”, “fixing portion”, “screen to display”, “a stylet”, “remote monitoring system” as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are also objected to because:
In Fig.1, the figure consists only unlabeled blocks identified by reference numerals without any adequate level of details/description/discloser/structure or functional relationships of the components.
In Fig.5, the steps should include descriptions of the method.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities:
Amended application priority section (Page 1) have a different application number (EP 21468869.6) than claimed priority (EP 24168869.6) (note the underlined second and third numbers are reversed).
Reference numerals listed on specification (Page 9) are not discussed in the detail description. The specifications list “recess (11)”, “first pole of generator (12)”, “second pole of generator (13)”, “second recess, IS-1 terminal (15)”, and “second pole (35)”, however have no detailed description of the embodiments.
Appropriate correction is required.
Claim Objections
Claim 1-6, 8-12, and 15 objected to because of the following informalities:
In Claim 1, line 1, “System” should read “A system”.
In Claim 1-3, and 8-10, “the generator” should read “the stimulation pulse generator”.
In Claim 1-6, 9-11, and 15, “the electrode” should read “the at least one electrode”.
In Claim 8, “an implantable pulse generator, IPG, an implantable cardioverter defibrillators, ICD, a generator for cardiac resynchronization therapy with a defibrillator, CRT-D, a generator for cardiac resynchronization therapy with a pacemaker, CRT-P” should read “an implantable pulse generator (IPG), an implantable cardioverter defibrillators (ICD), a generator for cardiac resynchronization therapy with a defibrillator (CRT-D), a generator for cardiac resynchronization therapy with a pacemaker (CRT-P)”. In other words, as currently worded, the acronyms appear as separate individual listed items, whereas typically they are introduced within parentheses.
In Claim 9, the term “IS-1 terminal” is introduced without prior definitions/description of the complete term.
In Claim 11, the abbreviation “HMSC” is introduced without prior definitions/description of the complete term.
In Claim 12, “left bundle branch, LBB, myocardial-only and/or Bundle branch block, BBB” should read “left bundle branch (LBB), myocardial-only and/or Bundle branch block (BBB)”.
In Claim 12, the abbreviation “LV-threshold-test” is introduced without prior definitions/description of the complete term.
Appropriate correction is required.
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.
Claim 1 and 11-12 is/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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 1 recites the broad recitation “providing stimulation to a patient”, and the claim also recites “in particular stimulation to a left bundle branch area of the heart of the patient”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding Claim 12, the claim recites “correction capture threshold(s) separately or in combination for a substantially manual LV-threshold-test”. The term “substantially” in claim 12 is a relative term which renders the claim indefinite. The terms is/are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. These phrases recited in the claim introduce exemplary and/or no-limiting language without clearly defining claim scope. It is therefore unclear if subsequently recited feature is required limitation or merely examples of possible embodiments.
Regarding claim 11-12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2, 4-5, 7-9, 11, and 14-15 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims recite the broad recitation that “the generator comprises at least one predefined parameter configured to indicate a position of the electrode, preferably of the distal end of the electrode … (see claim 2)”, “a helical structure having a length of 0.1 to 5 mm, preferably 0.5 to 4 mm … (see claim 4)”, and/or “preferably at least 2 mm and/or of at most 5 mm (see claim 5)”, etc. and the claim also recites that "preferably", “and/or”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It appears that, Applicant is intending to claim the narrower limitations. As such, there is no reason to also claim the broader limitation.
Claim 9 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 claim recites, “the second recess comprising a terminal, preferably an IS-1 terminal”. The term ”IS-1 terminal” is not defined in the claim or the specification, and the applicant does not identify the standard or meaning associated with the abbreviation. The claim is indefinite and the scope of the claim can’t be determined with reasonable certainty.
Claim 11 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. Claim 11 recites “information is preferably configured to be uploaded to remote monitoring system, HMSC”, the abbreviation “HMSC” is not previously defined in the claims and its meaning is unclear. The specifications also lack reasonable details/definition to provide scope and meaning of the claim, therefore scope of the claim cannot be determined.
Claim 12 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. Claim 12 recites “patient is allowed to enter … capture threshold(s) separately or in combination for a substantially manual LV-threshold-test.”, the term “LV-threshold-test” is not previously defined in the claims and its meaning is unclear. Additionally, “substantially manual” lacks objective standard for determining the degree of operation and it is unclear what it means to “patient … enter threshold”. The specifications also lack reasonable details/definition to provide scope and meaning of the claim, therefore scope of the claim cannot be determined.
Claim 14 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. Claim 14 recites, “the opening of the sheath comprises a stylet and/or wherein the sheath comprises a stylet”. The scope of the claim is unclear because of the narrow recitation that "the opening of the sheath comprises a stylet" and subsequently the broad recitation that "the sheath comprises a stylet", it is unclear whether broad range/limitation is actually required. It appears that, Applicant is intending to claim the narrower limitations. As such, there is no reason to also claim the broader limitation.
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)(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) 1-8 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US-20060142814-A1 to Lasker et al. (hereinafter “Lasker”).
Regarding Claim 1, Lasker disclose a system for providing stimulation to a patient (see Para 47: “a physiological pacing delivery system 80”, in particular stimulation to a left bundle branch area of the heart of the patient (see Para 31-32: “An electrical impulse starting at SA node 1 travels rapidly through RA 10 and a left atrium 8 (FIG. 15) to AV node 2. At AV node 2, the impulse slows to create a delay before passing on through a bundle of His 3, which branches, in an interventricular septum 7, into a right bundle branch 4 and a left bundle branch 84 (FIG. 15) … It should be noted that physiological pacing lead 26 may be implanted such that electrode array 28 is embedded in relative proximity to any other portion of the heart's intrinsic conduction system, such as right bundle branch 4 or left bundle branch (not shown) in the interventricular septum near a site 22”), the system comprising:
a stimulation pulse generator (see Para 31: “An electrical impulse starting at SA node 1 travels rapidly through RA 10 … The lead electrodes stimulate RA 10 downstream of damaged SA node 1 and the stimulating pulse travels on to AV node 2” and Para 4-6);
at least one electrode (see Para 33-34: “… one or a pair of electrodes 36, 37, 38, 39 may be selected for pacing”) having a distal end for being engaged with the patient and a proximal end for being engaged with the generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end comprises a fixing portion (see Para 33: “A fixation element 35”) configured to facilitate implanting in the septum (see Para 31-35 and 39);
a sheath (see Para 45: “piercing tool 70 includes an elongated hollow shaft 71”, and Fig.7B) having a three-dimensional opening for guiding the at least one electrode for implanting of the electrode (see Para 45: “a piercing tool 70 used to implant electrode array 28 of physiological pacing lead 26 … a piercing action to facilitate insertion of electrode array 28 into tissue” and Para 47-48, 50);
wherein the generator, the electrode and the sheath are adapted for use in combination with each other (see Para 47-48: “Delivery system 80 includes physiological pacing lead 26 and piercing tool 70. FIG. 8 illustrates an interface of electrode array 28 and fixation element 35 with piercing tip 73 and longitudinal recess 78 … FIG. 9A is a side plan view of a means for assembling delivery system 80. As illustrated in FIG. 9B, proximal end 29 of physiological pacing lead 26 is inserted, according to arrow G, into lumen 77 of piercing tool 70, at a distal end 701 of piercing tool 70, resulting in delivery system 80”).
Regarding Claim 2, Lasker further disclose the system of claim above, wherein the generator comprises at least one predefined parameter configured to indicate a position of the electrode, preferably of the distal end of the electrode when implanted in the septum of the heart (see Para 54-59: “… zone 220 physiological pacing may be further optimized for good detection of ventricular activity and relatively efficient pacing. According to a method of the present invention, one or a pair of electrodes are inserted into zone 220 and positioned such that the following criteria are met: … a ratio of an amplitude of sensed atrial electrical activation (P-wave amplitude) to an amplitude of sensed ventricular activation (R-wave amplitude) … a pacing threshold …”, also Para 32: “physiological pacing lead 26 may be implanted such that electrode array 28 is embedded in relative proximity to any other portion of the heart's intrinsic conduction system, such as right bundle branch 4 or left bundle branch (not shown) in the interventricular septum near a site 22”).
Regarding Claim 3, Lasker further disclose the system of claim above, wherein the generator comprises stimulation and/or diagnostic functions that are configured to be dependent upon a location of the distal end of the electrode (see Abstract: “delivering physiological pacing includes selecting an electrode implant site within an interventricular septal zone, which is in proximity to the bundle of His where pacing stimulation results in a rhythm breaking out at an intrinsic location”, also Para 55-56 (disclose electrode location for pacing)).
Regarding Claim 4, Lasker further disclose the system of claim above, wherein the fixing portion comprises a helical structure (see Para 35: “Fixation element 35, having a collar 45 and a helical hook 46 …”) having a length of 0.1 to 5 mm, preferably 0.5 to 4 mm, preferably 1 to 3 mm, most preferably 1.5 to 1.8 mm, the helical structure configured to allow the distal end of the electrode to be screwed in the septum (see Para Fig. 4A and Para 39-40 (length compared to electrodes in drawing), 47, 50-52),
wherein the helical structure is preferably a piece separate from the electrode such that the helical structure can be at least partially removably attached to the electrode (see Fig.4A, 4D, and Para 39, 47-52, 60).
Regarding Claim 5, Lasker further disclose the system of claim above, wherein the fixing portion comprises a first pole and the electrode comprises a second pole in proximity of the distal end, preferably between 1 to 10 mm, preferably 2 to 9 mm, preferably 3 to 8 mm, preferably 4 to 7 mm, preferably 5 to 6 mm spaced apart from the distal end, the first and the second pole configured to provide stimulation to the patient (see Fig.4A (electrode array 28, fixation element 35)), wherein the electrode is preferably a bipolar electrode (see Fig.4A (electrode 36, 37, 38, 39, electrode array 28)),
wherein the second pole has preferably the shape of a ring, preferably having a length along the longitudinal direction of the electrode of at least 0.5 mm, preferably at least 1 mm, preferably at least 1.5 mm, preferably at least 2 mm and/or of at most 5 mm, preferably at most 4 mm, preferably at most 3 mm, preferably at most 2 mm (see Fig.4A, Fig.5).
Regarding Claim 6, Lasker further disclose the system of claim above, wherein the sheath has an inner surface facing the opening, wherein the inner surface is configured so as to facilitate guiding the electrode (see Fig. 8A-8B).
Regarding Claim 7, Lasker further disclose the system of claim above, wherein the stimulation is configured to provide left bundle branch area pacing, wherein the system is preferably a conduction system pacing system (see Para 31-34: “… physiological pacing lead 26 may be implanted such that electrode array 28 is embedded in relative proximity to any other portion of the heart's intrinsic conduction system, such as right bundle branch 4 or left bundle branch (not shown) in the interventricular septum near a site 22 …”).
Regarding Claim 8, Lasker further disclose the system of claim above, wherein the generator is one or more of an implantable pulse generator, IPG, an implantable cardioverter defibrillators, ICD, a generator for cardiac resynchronization therapy with a defibrillator, CRT-D, a generator for cardiac resynchronization therapy with a pacemaker, CRT-P (see Para 41: “an IPG connector module”).
Regarding Claim 14, Lasker further disclose the system of claim above, wherein the opening of the sheath comprises a stylet and/or wherein the sheath comprises a stylet, wherein the sheath is preferably a catheter (see Fig 4A (stylet wire 59), 11A-13E (piercing stylet 110, piercing stylet 150), and Para 42, 51-54).
Regarding Claim 15, Lasker further disclose the system of claim above, wherein the sheath comprises a first deformation in a first plane and a second deformation in a second plane, the second plane being different from the first plane (see Fig.7B (piercing tool 70) and Para 45, 50),
wherein the sheath is configured to be cut so as to facilitate removal of the sheath preferably after implanting the electrode, wherein preferably a tool can be used in order to cut the sheath (see Fig.7B, 13B-E, and Para 45, 50, 54).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laske as applied to claim 1 above, and further in view of US 20090163822 A1 to Doan (hereinafter “Doan”).
Regarding Claim 9, Lasker further disclose the system of claim above, wherein the generator comprises a recess for being engaged with the proximal end of the electrode, the recess comprising a first and a second pole for providing the stimulation to the electrode when the electrode is engaged with the recess (see Para 47: “an interface of electrode array 28 and fixation element 35 with piercing tip 73 and longitudinal recess 78 …”, and Fig.8A - 13E).
However, fails to teach a second recess for being engaged with a further electrode, the second recess comprising a terminal, preferably an IS-1 terminal, wherein the further electrode is preferably an electrode configured to be implanted to provide stimulation to a left bundle branch area of the heart of the patient or not to provide stimulation to a left bundle branch area of the heart of the patient.
Another reference, Doan disclose implantable cardiac stimulation devices and, more specifically, to a lead system implanted through a septal wall (see Para 02) wherein the generator preferably comprises a second recess for being engaged with a further electrode, the second recess comprising a terminal, preferably an IS-1 terminal, wherein the further electrode is preferably an electrode configured to be implanted to provide stimulation to a left bundle branch area of the heart of the patient or not to provide stimulation to a left bundle branch area of the heart of the patient (see Fig.1 (an implantable stimulation device in electrical communication with several leads implanted in a patient's heart for measuring pressure and delivering multi-chamber stimulation and shock therapy) and Para 53-61).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Laske to be combined with a second recess as taught by Doan in order to permit connection of additional pacing lead, thereby improving compatibility with conventional implantable cardiac leads and allowing multiple pacing configuration to be supported.
Regarding Claim 10, Lasker disclose the system of claim above, but fail to disclose a programming interface comprising a switch configured to indicate whether or not the electrode is implanted.
However, Doan further disclose a lead system implanted through a septal wall (see Para 02), wherein the generator comprises a programming interface comprising a switch configured to indicate whether or not the electrode is implanted in the left bundle branch area of the heart of the patient (see Para 65 (stimulation device 100 is a programmable microcontroller 220 ), 67 (pulse generator 222/224, switch 226), 70-71, 75, 82 (detecting when the device has been implanted)),
wherein the switch is configured to be activated when the electrode is implanted in the left bundle branch area of the heart of the patient (see Para 65, 67, 70, 82-83(“stimulation device 100 further includes an impedance measuring circuit 278 that is enabled by the microcontroller 220 … uses for an impedance measuring circuit 278 include … lead positioning or dislodgement; detecting operable electrodes and automatically switching to an operable pair if dislodgement occurs … detecting when the device has been implanted … coupled to the switch 226 so that any desired electrode may be used”)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the disclosed system of Laske to be combined with the teaching of Doan to incorporate a programming interface including a switch to indicate electrode implantation. Such modification would allow accurate identification of implanted electrode and facilities selection of appropriate programming parameters, thereby improving device usability and reducing therapeutic errors.
Regarding Claim 12, Lasker disclose the system of claim above, but fail to disclose when the switch is activated, a human such as the patient is allowed to enter left bundle branch, LBB, myocardial-only and/or Bundle branch block, BBB, correction capture threshold(s) separately or in combination for a substantially manual LV-threshold-test.
Doan further disclose a lead system implanted through a septal wall (see Para 02), wherein when the switch is activated, a human such as the patient is allowed to enter left bundle branch, LBB, myocardial-only and/or Bundle branch block, BBB, correction capture threshold(s) separately or in combination for a substantially manual LV-threshold-test (see Para 65-70, 76-79, 81-84 (measuring thoracic impedance for determining shock thresholds)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Laske to be combined with the teaching of Doan to individually assess and optimize pacing following implantation, thereby improving programming flexibility and more accurate threshold evaluation.
Regarding Claim 13, Lasker disclose the system of claim above, but fail to disclose providing stimulation to the patient is dependent on the information.
Doan further disclose a lead system implanted through a septal wall (see Para 02), wherein providing stimulation to the patient is dependent on the information (see Paea 65-67: “the stimulation device 100 is a programmable microcontroller 220 that controls the various modes of stimulation therapy. As is well known in the art, microcontroller 220 typically includes a microprocessor, or equivalent control circuitry, designed specifically for controlling the delivery of stimulation therapy … The pulse generators 222 and 224 are controlled by the microcontroller 220 via appropriate control signals 228 and 230, respectively, to trigger or inhibit the stimulation pulses”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Laske to be combined with the teaching of Doan to make the delivery of stimulation depending on electrode implantation information, thereby improving effectiveness while reducing need for manual intervention.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laske and Doan as applied to claim 10 above, and further in view of US 20220379126 A1 to Doerr et al. (hereinafter “Doerr”).
Regarding Claim 11, Lasker in view of Doan disclose the modified system of claim above, but fails to teach electrode implantation information is indicated to a human when the switch is activated.
Doan disclose a lead system implanted through a septal wall (see Para 02), wherein, when the switch is activated, the information that the electrode is implanted in the left bundle branch area of the heart of the patient is configured to be indicated to a human (see Para 82: “uses for an impedance measuring circuit 278 include … detecting when the device has been implanted … coupled to the switch 226), such as the patient,
wherein this information is preferably configured to be uploaded to remote monitoring system, HMSC (see Para 92-93: “an external monitoring device to provide a variety of pressure measurements in real time … the information generated by the leads may be provided to an external monitoring or control system”, and Para 104).
However, Doan fail to disclose a display screen to display the information on programmer printouts.
Another reference, Doerr disclose a programming device for programming an implantable medical device for stimulating a human or animal heart (see abstract), wherein preferably a brady parameter screen and/or a follow-up screen is/are configured to display this information (see Para 16, 30, 63-65: “The programming device 2 comprises a display”),
wherein this information is preferably configured to be made available on programmer printouts (see Para 9, 33-35, 41-46, 54-59, 63-65).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed system of Laske to be combined with the teaching of Doan and Doerr to provide a display screen to provide information to the clinicians/human to improve clinical documentation and accessible implant information for monitoring/evaluation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20090259272-A1 - Art relevant as a whole (see abstract).
US 20120157813 A1 - Art relevant as a whole (see abstract, Para 6, 41-51).
US 20190388701 A1 - Art relevant as a whole (see abstract).
US 11045653 B1 - Art relevant as a whole (see abstract).
US 11471190 B2 - Art relevant as a whole (see abstract).
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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