CTNF 18/587,193 CTNF 98329 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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) and Species 1A, 2B, 3A, 4A, 5A, 6A, 7C, and identifying that all pending claims (1-12) encompasses this election in the reply filed on 05/26/2026 is acknowledged. Claims 22-29 are hereby withdrawn. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-12 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. In re claim 1 , the following limitations lack antecedent basis: the triangle of Koch region the right atrium the right-atrial endocardium In re claim 2 the following limitations lack antecedent basis: the left ventricle the basal and/or septal region the left ventricular myocardium In re claim 4 , the following limitations lack antecedent basis: the great cardiac vein the middle cardiac vein In re claim 5 , the following limitations lack antecedent basis: the non-coronary cusp the aortic valve the position of the aortic valve the valve plane In re claim 9 , the following limitation lacks antecedent basis: the left ventricle Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-3, 6-8, and 12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by By rd et al. (US 2004/0116878) . In re claim 1 , Byrd discloses a method for delivering a medical device ([0001]: introduction and implantation of cardiac leads), the method comprising: locating a potential implantation site in the triangle of Koch region in the right atrium of a patient's heart ([0093]: guide catheter is used to implant cardiac lead in right atrium known of triangle of Koch); attaching a fixation sheath ([0020]: lead body enclosed within lumen of a sheath) to the right-atrial endocardium ([0007-0008]: endocardial cardiac lead inserted into right atrium) in the potential implantation site [0021]; and implanting the medical device over a guide wire at the potential implantation site [0025, 0035]. In re claim 2 , Byrd discloses a further comprising implanting a left-ventricular electrode ([0092]: pace/sense electrode may be placed near left ventricle; [0070]: distal electrode 34(s) can be positioned deep within anterior interventricular vein 46 to provide LV sensing and stimulation) of the medical device [0092] from the triangle of Koch region of the right atrium [0093] through the right-atrial endocardium ([0063]: may comprise of endocardial cardiac lead; [0007]) and central fibrous body ([0102]: cardiac lead may be guided to implanted in interventricular septum which would go through right-atrial endocardium and central fibrous body) to deliver cardiac therapy to or sense electrical activity ([0015]: cardiac leads accommodate electrodes; [0063]: electrodes are pace/sense electrodes) of the left ventricle in the basal and/or septal region of the left ventricular myocardium of a patient's heart ([0102]: catheter body is guided to implant cardiac lead in interventricular septum which would provide sensing of electrical activity of the left ventricle in the septal region). In re claim 3 , Byrd discloses further comprising positioning a right-atrial electrode ([0093]: pace/sense electrode may be positioned in right atrium) of the medical device to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart [0093]. In re claim 6 , Byrd discloses wherein attaching a fixation sheath ([0022]: inner sheath is interpreted as a fixation sheath; [0105-0106]: all patents and publications are incorporated by reference and combinations between embodiments may be made) to the right-atrial endocardium ([0007]: fixation mechanism for permeant endocardial lead) in the potential implantation site [0021] comprises: introducing a steerable sheath ([0022]: outer sheath is interpreted as a steerable sheath since it is pushed to site) into the right atrium of the patient's heart ([0007]: cardiac lead advanced into right atrium); and guiding the fixation sheath at least partially disposed in the steerable sheath to the potential implantation site [0022]. In re claim 7 , Byrd discloses wherein attaching a fixation sheath to the right-atrial endocardium in the potential implantation site comprises rotating the fixation sheath relative to the steerable sheath ([0021-0022]: inner sheath is moved out of the outer sheath to advance a distal tip comprising a fixation helix that is rotated to be screwed into the myocardium and therefore the fixation sheath must be rotated relative to the steerable sheath; [0018]). In re claim 8 , Byrd discloses further comprising: determining whether the potential implantation site is acceptable ([0097]: angiographic procedure is done to identify a suitable implantation site); and preparing the potential implantation site for a medical device in response to determining that the potential implantation site is acceptable ([0031]: instruments of diagnostic fluids can be advances to facilitate advancement of catheter body to implantation site; [0065-0067]: inherent that implantation site would be prepared once an acceptable implantation site is identified; [0095]). In re claim 12 , Byrd discloses, wherein implanting the medical device over a guide wire comprises ([0074]: guidewire used to implant electrode; [0094]: multiple electrodes may be implanted) implanting one or more of a right-atrial electrode [0093], a left-ventricular electrode [0092], and an intracardiac medical device . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (US 2004/0116878) in view of Bonner et al. (US 6,647,291) (hereinafter referred to as Bonner (‘291)) . In re claim 4 , Byrd discloses wherein locating a potential implantation site comprises: introducing a first guide wire ([0095]: stylet 90 is a first guidewire since it’s used to advance bilumen guide catheter 100' into the right atrium) to the coronary sinus of the patient's heart [0095]; introducing a second guide wire ([0095]: second guide wire is stylet wire 192; fig. 165: 192); and identifying the potential implantation site based on a position of the first guide wire relative to a position of the second guide wire ([0095]: both of the stylets have to be used relative to one another to identify the implantation site, preferably at a desired location in the triangle of Koch). Byrd fails to disclose introducing a first guide wire through the great cardiac vein ; introducing a second guide wire to the middle cardiac vein of the patient's heart . Bonner (‘291) teaches a cardiac defibrillation system (Col. 1, lines 61-65) and wherein a lead (Fig. 2: 22) is inserted by passing a guidewire (Col. 3, lines 55-63) into a coronary sinus (Col. 3, lines 55-63) to an apex of a heart (Col. 3, lines 55-63) and through a middle cardiac vein (Col. 3, lines 55-63) and wherein the guidewire is advanced toward a base of the heart through the great cardiac vein (Col. 3, lines 55-63). Bonner (‘291) further teaches that the lead may be advanced to its desired location using the guidewire (Col. 3, lines 55-63), and that the lead may either go through the great cardiac vein or through the middle cardiac vein (Col. 3, line 64-Col. 4, line 5). It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for delivering a medical device taught by Byrd, to provide introducing a first guide wire through the great cardiac vein and introducing a second guide wire to the middle cardiac vein of the patient's heart, as taught by the guidewire of Bonner (‘291), because the lead may be advanced to its desired location and the lead may either go through the great cardiac vein or through the middle cardiac vein, therefore the two guidewires of Byrd can be used to find the desired location. The proposed combination would yield introducing the first guide wire of Byrd through the great cardiac vein and introducing the second guide wire of Byrd to the middle cardiac vein of the patient's heart, so the lead can be implanted in the desired location, as taught by the guidewire of Bonner (‘291) . 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (US 2004/0116878) in view of Bonan (US 2007/0288000) . In re claim 5 , Byrd discloses wherein locating a potential implantation site comprises one or more of: placing a diagnostic catheter retrograde aortic to the non-coronary cusp of the aortic valve of the patient's heart and using a tip of this device as a target reference in both parallel and perpendicular views of a valve plane (optional); and identifying a target placement for a left-ventricular electrode relative to the position of the aortic valve based on capturing an aortogram ([0097]: angiographic procedure done to identify suitable implantation site and would include identifying placement of a left-ventricular electrode discussed in claim 2 above) or ventriculogram. Byrd fails to disclose identifying a target placement for a left-ventricular electrode relative to the position of the aortic valve based on capturing an aortogram or ventriculogram using parallel and perpendicular views of the valve plane. Bonan teaches an implantation of a heart valve annuloplasty device [0002] by a catheter [0002] and teaches identifying a target placement ([0042]: spatial mapping of chambers and structure of heart needed for knowing where to advance catheter [0045]) based on capturing an ventriculogram [0042] using parallel and perpendicular views of the valve plane ([0042]: perpendicular and parallel views allow clinicians to determine interior structure of heart relative to A-V grove). Bonan further teaches that views in humans have to be tailored based on a coronary angiogram to determine location of various heart structures [0042]. It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for delivering a medical device taught by Byrd, to provide identifying a target placement for a left-ventricular electrode relative to the position of the aortic valve based on capturing an aortogram or ventriculogram using parallel and perpendicular views of the valve plane, as taught by Bonan, because views in humans have to be tailored based on a coronary angiogram to determine location of various heart structures . 07-21-aia AIA Claim s 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (US 2004/0116878) in view of Bonner et al. (US 2005/0261673) (hereinafter referred to as Bonner (‘673)) US 20150265840) in view of Ghosh et al. (US 2015/0265840) . In re claim 9 , Byrd discloses wherein determining whether the potential implantation site is acceptable comprises: advancing a flexible needle ([0021-0022]: sheath lead body; fig. 1: cardiac lead 10 is shown as bending as it’s being inserted) and a dilator ([0022]: inner introducer is interpreted as a dilator) disposed at least partially in the fixation sheath ([0022]: inner introducer is inserted into outer sheath lumen to advance a distal tip) relative to the fixation sheath [0022] to engage tissue in the potential implantation site [0022]; monitoring electrical activity using the flexible needle ([0063]: leads comprise pace/sense electrodes that would monitor electrical activity; [0001]: sensing electrical activity). Byrd fails to disclose delivering pacing pulses at different depths between the right atrium and the left ventricle; and determining whether a pacing threshold is acceptable based on electrical activity measured in response to delivering pacing pulses using a plurality of external electrodes. Regarding the limitations, “ delivering pacing pulses at different depths between the right atrium and the left ventricle; and determining whether a pacing threshold is acceptable based on electrical activity measured in response to delivering pacing pulses ”, Bonner (‘673) teaches a method for implanting a cardiac lead [0003] and teaches delivering pacing pulses at different depths ([0119]: pacing threshold at different depth is measured to locate desired lead placement depth) between the right atrium and the left ventricle ([0119]: target site may be endocardial tissue which would include an area between the right atrium and the left ventricle); determining whether a pacing threshold is acceptable based on electrical activity measured in response to delivering pacing pulses [0119]; and reorienting a fixation sheath ([0119]: working lumen 20) from the right-atrial endocardium in response to determining that the pacing threshold is not acceptable ([0119]: if pacing threshold is not desirable at a certain location, then depth can be changed i.e. reorientated until the desired pacing threshold is achieved). Bonner (‘673) further teaches that a deeper location of the pacing threshold may be more advantageous [0119], and tissues at different depths may be more viable sites for lead placement [0119]. It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for delivering a medical device taught by Byrd, to provide delivering pacing pulses at different depths between the right atrium and the left ventricle; determining whether a pacing threshold is acceptable based on electrical activity measured in response to delivering pacing pulses; and reorienting a fixation sheath from the right-atrial endocardium in response to determining that the pacing threshold is not acceptable, as taught by Bonner (‘673), because a deeper location of the pacing threshold may be more advantageous, and tissues at different depths may be more viable sites for lead placement. Regarding the limitations, “ determining.. a pacing threshold… based on electrical activity measured in response to delivering pacing pulses using a plurality of external electrodes ”, Ghosh further teaches providing pacing therapy [0004] and providing electrical signals to a heart [0045-0046], and teaches delivering pacing pulses [0007, 0047] and measuring electrical activity using a plurality of external electrodes [0007,0148], including determining a pacing threshold ([0157]: thresholds measured associated with pacing therapy) using the external electrodes [0157]. Ghosh further teaches that using a plurality of external electrodes avoids artifacts and outliers [0157] and external locations of the external electrodes [0147, 0158] may be used to detect whether a nerve has been stimulated [0158]. It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for delivering a medical device yielded by Byrd, to provide determining a pacing threshold based on electrical activity measured in response to delivering pacing pulses using a plurality of external electrodes, as taught by Ghosh, because using a plurality of external electrodes avoids artifacts and outliers and external locations of the external electrodes may be used to detect whether a nerve has been stimulated. In re claim 10 , regarding the limitation, “ further comprising: reorienting the fixation sheath from the right-atrial endocardium in response to determining that the pacing threshold is not acceptable ”, see the proposed combination yielded in re claim 9 above . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd et al. (US 2004/0116878) in view of Warman et al. (US 5,922,014) . In re claim 11 , Byrd discloses wherein preparing the potential implantation site for a medical device comprises: advancing the guide wire into the potential implantation site [0074, 0097]; removing a fixation sheath ([0095]: first stylet 90 is interpreted as a fixation sheath since it’s used to advance catheter 100’) before, during, or after advancing the lead over the guide wire ([0094-0095]: first stylet 90 is removed before second stylet 190 i.e. guidewire is fitted and used to locate the implantation site; [0102-0103]: lead is advanced using guidewire or stylet). Byrd fails to disclose advancing a pacing lead over the guide wire to test pacing thresholds; and removing the fixation sheath before, during, or after advancing the pacing lead over the guide wire. Warman teaches an implantable single pass cardiac pacing lead (Col. 1, lines 5-7) and teaches wherein preparing a potential implantation site of for a medical device (Col. 6, lines 3-6: preparing for lead to be implanted) comprises advancing a pacing lead (Col. 1, lines 5-7: leads are pacing leads; fig. 1: comprises electrodes 16 and 18; Col. 6, lines 3-18: electrodes 16 and 18 provide pacing) over a guide wire (Col. 6, lines 3-22: stylet is interpreted as a guide wire) to test pacing thresholds (Col. 6, lines 3-18: electrodes 16 and 18 are tested for acceptable pacing thresholds); and removing a guide wire before, during, or after advancing the pacing lead over the guide wire (Col. 6, lines 3-22). Warman further teaches that acceptable pacing thresholds are used to determine acceptable positions of the electrodes (Col. 6, lines 14-18). It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for delivering a medical device yielded by Byrd, to provide advancing a pacing lead over the guide wire to test pacing thresholds; and removing the fixation sheath before, during, or after advancing the pacing lead over the guide wire, as taught by the pacing lead and the guide wire of Warman, because acceptable pacing thresholds are used to determine acceptable positions of the electrodes . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure : Bullinga discloses (US 2019/0143118) discloses cardiac leads for right and left ventricles (abstract), wherein inner and outer leads are positioned in target vessels [0081]. Contact Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RUMAISA RASHID BAIG/Examiner, Art Unit 3796 /DAVID HAMAOUI/SPE, Art Unit 3796 Application/Control Number: 18/587,193 Page 2 Art Unit: 3796 Application/Control Number: 18/587,193 Page 3 Art Unit: 3796 Application/Control Number: 18/587,193 Page 4 Art Unit: 3796 Application/Control Number: 18/587,193 Page 5 Art Unit: 3796 Application/Control Number: 18/587,193 Page 6 Art Unit: 3796 Application/Control Number: 18/587,193 Page 7 Art Unit: 3796 Application/Control Number: 18/587,193 Page 8 Art Unit: 3796 Application/Control Number: 18/587,193 Page 9 Art Unit: 3796 Application/Control Number: 18/587,193 Page 10 Art Unit: 3796 Application/Control Number: 18/587,193 Page 11 Art Unit: 3796 Application/Control Number: 18/587,193 Page 12 Art Unit: 3796 Application/Control Number: 18/587,193 Page 13 Art Unit: 3796 Application/Control Number: 18/587,193 Page 14 Art Unit: 3796
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