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 .
Claim Rejections - 35 USC § 112
Claims 23,24,26,28,30 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 claim 23, the anode connector lacks antecedent basis.
In claim 24, the anode connector lacks antecedent basis.
Claim Rejections - 35 USC § 102
Claim(s) 1,13,15-20,23,25,29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al (2022/0088395).
(Original) A system (100) for assisting regulated depth insertion of an implantable lead into the heart muscle (myocardium) of a subject, wherein the lead (60) is configured for transmission of electrical signals, the system (100) (see at least figure 2 which shows lead 22 and ¶31 which teaches sensing signals from heart) comprising: -
an adapter (30) having a distal (10) end and a proximal (12) end comprising: (figure 2 shows adapter 42)
an adapter distal connector (32) configured for dismountable mechanical and electrical attachment to a lead proximal connector (62) of the implantable lead (60), wherein the adaptor distal connector (32) is configured to mechanically attach in fixed rotational relation with respect to the lead proximal connector (62); (figure 3a shows adapter 42 and lead 22, where the lead rotates along with the bearing 64 and; see at least ¶35)
a rotational interface (34), comprising a rotational joint (36) having a distal body (36a) rotationally attached to a proximal body (36b), the rotational interface (34) configured for conductance of electrical signals across the rotational joint (36); (see at least figure 3a and ¶38 which teaches components 70a and 70b where they are joined electrically and where the component 70a rotates relative to the fixed component 70b)
an adapter proximal connector (38) configured for repeatable electrical connection to a pacing spectrum analyser (PSA) (200), (see at least figure 3a which shows connector 72 which can be used to connect to the analyzer, and ¶40) optionally via one or more extension or adapter cables (150); the adapter (30) being configured such that:
electrical signals are transmittable between a distal helical electrode (64) of the implantable lead (60) and the adapter proximal connector (38) during rotations of or induced in the distal body (36a); (as mentioned, the distal electrode 25a is connected to the proximal portion 62 of lead, where the lead can rotate relative to the body of the adapter)
the rotations of or induced in the distal body (36a) change the depth of the helical electrode (64) in the heart muscle; (see at least ¶6,7)
rotation of the adapter proximal of the rotational joint (36b through 38) is reduced or eliminated during the rotations of or induced in the distal body (36a). (rotation of adapter is eliminated since the component 70a rotates while the component 70b does not rotate; ¶39)
13. (New) The system (100) according to claim 1, wherein the implantable lead (60) comprises shaft body (66), whereby the distal helical electrode (64) is attached at distal end (10) of shaft body (66) in fixed axial rotation with the shaft body (66), and the lead proximal connector (62) is attached at proximal end (12) of shaft body (66) in fixed axial rotation with the shaft body (66). (see at least ¶27 which teaches a fixed helix that is fixed relative to the lead body, and figure 3a which shows proximal connector 66a)
15. (New) The system (100) according to claim 1, wherein the implantable lead (60) is configured for transmission of torque between the distal helical electrode (64) and the lead proximal connector (62). (as the lead is turned, torque is transmitted between electrodes 25a and connector 66a so that the helix depth can be adjusted)
16. (New) The system (100) according to claim 15, wherein the implantable lead (60) is configured for the transmission of the torque in the absence of a removeable stylet. (since the helix electrode is fixed, no stylet is necessary, ¶27)
17. (New) The system (100) according to claim 1, wherein the implantable lead (60) distal helical electrode (64) is configured for insertion into a left bundle branch area of the subject’s myocardium, or into the His-bundle of the subject’s myocardium. (see at least ¶26)
18. (New) The system (100) according to claim 16, wherein the implantable lead (60) distal helical electrode (64) is configured for insertion into a left bundle branch area of the subject’s myocardium, or into the His-bundle of the subject’s myocardium. (see at least ¶26)
19. (New) The system (100) according to claim 1, wherein the rotational interface (34) is configured for continuous transmission of electrical signals from the distal helical electrode (64) to the adapter proximal connector (38), and to reduce or prevent twisting of an adapter proximal lead (37) connecting the proximal body (36b) to the adapter proximal connector (38) during the rotations of or induced in the distal body (36a). (see at least ¶35-40. As the lead 22 is rotated, the connector 72 does not rotate, and thus isn’t twisted)
20. (New) The system (100) according to claim 18, wherein the rotational interface (34) is configured for continuous transmission of electrical signals from the distal helical electrode (64) to the adapter proximal connector (38), and to reduce or prevent twisting of an adapter proximal lead (37) connecting the proximal body (36b) to the adapter proximal connector (38) during the rotations of or induced in the distal body (36a). (see at least ¶35-40. As the lead 22 is rotated, the connector 72 does not rotate, and thus isn’t twisted)
23. (New) The system (100) according to claim 1, wherein the anode connector (40) comprises a tissue fixation element for dismountable attachment to tissue of the subject. (as mentioned supra, anode connector lacks antecedent basis. Further, the electrode 48, which includes an adhesive patch, can be considered the anode electrode. The electrode can be anode or cathode depending upon how it is used)
25. (New) The system (100) according to claim 1, further comprising the implantable lead (60). (See figure 1 which shows lead 22)
29. (New) The system (100) according to claim 1, further comprising the one or more extension or adapter cables (150). (see figure 2 which shows cable 46)
Claim Rejections - 35 USC § 103
Claim(s) 2,14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (2022/0088395) and Reddy et al (2009/0259272).
2. (Original) The system (100) according to claim 1, wherein the implantable lead (60) is lumenless. (at least ¶25 of Reddy teaches a lumenless lead. It would have been obvious to use such with Yang since it would eliminate the need for a stylet; making a more simple compact design).
14. (New) The system (100) according to claim 2, wherein the implantable lead (60) comprises shaft body (66), whereby the distal helical electrode (64) is attached at distal end (10) of shaft body (66) in fixed axial rotation with the shaft body (66), and the lead proximal connector (62) is attached at proximal end (12) of shaft body (66) in fixed axial rotation with the shaft body (66). (see at least ¶27 which teaches a fixed helix that is fixed relative to the lead body, and figure 3a which shows proximal connector 66a)
Claim(s) 21,22,24,26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (2022/0088395) and McCorkle (4,332,259).
21. (New) The system (100) according to claim 1, wherein the adapter proximal lead (37) is adapted for transmission of:
- electrical signals between the adapter proximal connector (38) and the proximal body (36b) via one or more electrically conductive cables within the adapter proximal lead (37), (see figure 2 of Yang)
- electrical signals between the adapter proximal connector (38) and an anode connector (40) via one or more further electrically conductive cables within the adapter proximal lead (37). (McCorkle teaches a branch lead from the main lead. To use such a design with the device of Yang would have been obvious since it would produce predictable results such as the ability to use more/other testing equipment without having to disconnect the test device 44 of Yang. To have other cables within the adaptor of Yang would facilitate the extra branch lead in a predictable manner)
22. (New) The system (100) according to claim 20, wherein the adapter proximal lead (37) is adapted for transmission of:
- electrical signals between the adapter proximal connector (38) and the proximal body (36b) via one or more electrically conductive cables within the adapter proximal lead (37), (see figure 2 of Yang)
- electrical signals between the adapter proximal connector (38) and an anode connector (40) via one or more further electrically conductive cables within the adapter proximal lead (37). (McCorkle teaches a branch lead from the main lead. To use such a design with the device of Yang would have been obvious since it would produce predictable results such as the ability to use more/other testing equipment without having to disconnect the test device 44 of Yang. To have other cables within the adaptor of Yang would facilitate the extra branch lead in a predictable manner)
24. (New) The system (100) according to claim 22, wherein the anode connector (40) comprises a tissue fixation element for dismountable attachment to tissue of the subject. (as mentioned supra, anode connector lacks antecedent basis. Further, the electrode 48, which includes an adhesive patch, can be considered the anode electrode. The electrode can be anode or cathode depending upon how it is used)
26. (New) The system (100) according to claim 24, further comprising the implantable lead (60). (See figure 1 which shows lead 22)
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (2022/0088395) and Luther et al (2012/0197328).
27. (New) The system (100) according to claim 1, further comprising the pacing spectrum analyser (200). (Pacing spectrum analyzers are considered to be well known in the art and obvious to use to determine the best pacing frequency for the patient; see at least ¶54 of Luther)
Claim(s) 28,30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (2022/0088395) and McCorkle (4,332,259), and further in view of Luther et al (2012/0197328).
28. (New) The system (100) according to claim 26, further comprising the pacing spectrum analyser (200). (Pacing spectrum analyzers are considered to be well known in the art and obvious to use to determine the best pacing frequency for the patient; see at least ¶54 of Luther)
30. (New) The system (100) according to claim 28, further comprising the one or more extension or adapter cables (150). (see figure 2 of Yang which shows cable 46)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/Scott M. Getzow/Primary Examiner, Art Unit 3792
Prosecution Insights