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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-20 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.
Claim 1 recites, “a lead extraction assistance device for use with a lead locking device (LLD)” which implies the lead locking device (LLD) as a separate component that the lead extraction assistance device interfaces or cooperates with. The claim later recites, “the apparatus comprising: a lead locking device (LLD)” and it is unclear whether the lead locking device is part of the claimed apparatus or an additional, separate device the lead extraction assistance device is merely configured to functionally cooperate with.
Claim 1 additionally recites, “an assembly configured with a center shaft” before reciting “wherein an assembly clamps both an entered lead and an exited LLD” and “ a module disposed in the assembly and coupled to both the entered lead and the exited LLD” and it is unclear whether the two mentions of “an assembly” refer to the same “assembly” or different, separate assemblies. Further, it is unclear which “assembly” is being referenced in the limitation “a module disposed in the assembly”. This issue is also present in claim 5’s recitation of “the assembly”.
Claims 2-6 are also rendered indefinite due to their dependency and further modification of claim 1.
Claim 7 recites, “a lead extraction assistance device for use with a lead locking device (LLD)” which implies the lead locking device (LLD) as a separate component that the lead extraction assistance device interfaces or cooperates with. The claim later recites, “the apparatus comprising: a lead locking device (LLD)” and it is unclear whether the lead locking device is part of the claimed apparatus or an additional, separate device the lead extraction assistance device is merely configured to functionally cooperate with.
Claim 7 additionally recites, “an assembly configured with a center shaft” before reciting “wherein an assembly clamps both an entered lead and an exited LLD” and “ a module disposed in the assembly and coupled to both the entered lead and the exited LLD” and it is unclear whether the two mentions of “an assembly” refer to the same “assembly” or different, separate assemblies. Further, it is unclear which “assembly” is being referenced in the limitation “a module disposed in the assembly”.
Claims 8-12 are also rendered indefinite due to their dependency and further modification of claim 7.
Claim 13 recites, “a lead extraction assistance device for use with a lead locking device (LLD)” which implies the lead locking device (LLD) as a separate component that the lead extraction assistance device interfaces or cooperates with. The claim later recites, “the apparatus comprising: a lead locking device (LLD)” and it is unclear whether the lead locking device is part of the claimed apparatus or an additional, separate device the lead extraction assistance device is merely configured to functionally cooperate with.
Claim 13 additionally recites, “an assembly configured with a center shaft” before reciting “wherein an assembly clamps both an entered lead and an exited LLD” and “ a module disposed in the assembly and coupled to both the entered lead and the exited LLD” and it is unclear whether the two mentions of “an assembly” refer to the same “assembly” or different, separate assemblies. Further, it is unclear which “assembly” is being referenced in the limitation “a module disposed in the assembly”. This issue is also present in claim 17’s recitation of “the assembly”.
Claims 14-20 are also rendered indefinite due to their dependency and further modification of claim 7.
Allowable Subject Matter
Claims 1-20 would potentially be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Regarding claim 1, one of the closest prior art references of record, namely Francis (US 2021/0068867 A1) teaches:
An apparatus (see Fig. 3) comprising a lead extraction assistance device (326, see Fig. 3) for use with a lead locking device (LLD) (112, see Fig. 3) in a lead extraction procedure, the apparatus comprising:
a lead locking device (LLD) (112, see Fig. 3);
a lead locking assist device (mandrel 326, see Fig. 3) coupled to the LLD wherein the lead locking assist device comprises:
an assembly (104, see Fig. 3) configured with a center shaft (central shaft of mandrel 326, see Fig.3) that has an inlet for entry of the lead (lead enters housing 104 via rotation of mandrel 326 which winds lead engagement device 102 to draw the lead into the housing; see Para. [0040]-[0052]) and configured with an outlet for exit of the LLD (see Fig. 3); and
wherein the mandrel is configured to apply a rotational motion to draw the lead proximally for extraction from the tissue within which it is implanted (see Para. [0040]-[0052]).
However, Francis does not expressly disclose:
wherein an assembly clamps both an entered lead and an exited LLD; and
a module disposed in the assembly and coupled to both the entered lead and the exited LLD, the module configured to apply about the center shaft, a first action by a rotational motor to twist the entered lead, and a second action by a hammering device to impact with hammering actions to the entered lead to assist to draw out the lead and counter any resistance caused by affixed vascular adhesions during the lead extraction procedure.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Francis to comprise a clamping element to clamp onto both the entered lead and the exited LLD as doing so would cause the rotation of the mandrel to have no impact or effect in drawing the lead into the device for extraction. Further, it would not have been obvious to one of ordinary skill in the art to have modified the device of Francis to comprise a rotational motor connected to the mandrel to twist the lead, or to comprise a hammering device to impact the lead for extraction since, while both of these lead removal techniques are known in the art (see US 2014/0142594 Para. [0003]-[0008]; US 2016/0374721 A1 Para. [0079]; US 2017/0333016 A1 Para. [0117]; US 2015/0366585 A1 Para. [0043]-[0046]; and US 2020/0352552 A1 Para. [0313]-[0314]), none of the prior art indicates an express benefit to why twisting or impacting a lead is superior to applying tension thereto and would require substantial redesign of the extraction mechanism of the device of Francis while achieving the same result already present in the disclosure of Francis. Such a modification would entirely change the functioning of the extraction mechanism without any benefit over the currently disclosed method without a reasonable expectation of success in the effectiveness of the resulting modification.
Regarding claim 1, another prior art of record, namely Roedger (US 2017/0333016 A1) discloses:
An apparatus (see Fig. 1) comprising a lead extraction assistance device (apparatus 50, see Figs. 1-3) for use with a lead locking device (LLD)(snare 55, see Figs. 1-3) in a lead extraction procedure (see Para. [0012]-[0013]), the apparatus comprising:
a lead locking device (LLD) (snare 55, see Figs. 1-3);
a lead locking assist device (sheath 60 and subcomponents housed therein, see Figs. 1-3) coupled to the LLD wherein the lead locking assist device comprises:
an assembly configured with a center shaft (cannula 54, see Figs. 1-3) that has an inlet for entry of the lead (see Fig. 5) and configured with an outlet for exit of the LLD (see Figs. 1-3);
a mechanism configured to applying an impact, hammering action to the entered lead to assist to draw out the lead and counter any resistance caused by affixed vascular adhesions during the lead extraction procedure (tension applied by the snare applies an initial impact action to the lead to aid in removal, see Para. [0011]-[0014]).
However, Roedger does not expressly disclose:
wherein an assembly clamps both an entered lead and an exited LLD; and
a module disposed in the assembly and coupled to both the entered lead and the exited LLD, the module configured to apply about the center shaft, a first action by a rotational motor to twist the entered lead.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Roedger to comprise a clamping element to clamp onto both the entered lead and the exited LLD as doing so would restrict and limit the ability for the cannula (54) to be slid onto and off of the snare during the removal procedure (see Para. [0016]) while remaining in place during tensioning of the snare. To modify the connection between these components would not produce easily predictable results without undue experimentation to ensure the device retained functionality. Further, there would be no functional benefit to clamping the cannula onto the snare and such a modification would not be undertaken without an express reason or benefit since the resulting modification would change the interaction between the cannula and the snare, resulting in a change in the lead removal mechanism. Additionally, while the application of a twisting force is known in the art to aid in lead extraction (see US 2014/0142594 Para. [0003]-[0008]; US 2016/0374721 A1 Para. [0079]; US 2017/0333016 A1 Para. [0117]; US 2015/0366585 A1 Para. [0043]-[0046]; and US 2020/0352552 A1 Para. [0313]-[0314]), none of the prior art indicates an express benefit to why twisting of the lead is superior to applying tension and vibrational energy thereto and would require substantial redesign of the extraction mechanism of the device of Roedger while achieving the same result already present in the disclosure of Roedger. Such a modification would entirely change the functioning of the extraction mechanism without any benefit over the currently disclosed method without a reasonable expectation of success in the effectiveness of the resulting modification.
Claims 2-6 are also conditionally allowable pending resolution to the above 112(b) rejection(s) due to their dependency and further modification of claim 1.
Regarding claim 7, the closest prior art, namely Roedger, discloses:
An apparatus (see Fig. 1) comprising a lead extraction assistance device (apparatus 50, see Figs. 1-3) for use with a lead locking device (LLD)( snare 55, see Figs. 1-3) in a lead extraction procedure (see Para. [0012]-[0013]), the apparatus comprising:
a lead locking device (LLD) (snare 55, see Figs. 1-3);
a lead locking assist device (sheath 60 and subcomponents housed therein, see Figs. 1-3) coupled to the LLD wherein the lead locking assist device comprises:
an assembly configured with a center shaft (cannula 54, see Figs. 1-3) that has an inlet for entry of the lead (see Fig. 5) and configured with an outlet for exit of the LLD (see Figs. 1-3);
a mechanism having a vibration source (vibration generator 30, see Fig. 1) and configured to applying an a vibration to the central shaft and the entered lead (see Para. [0011]-[0016]).
However, Roedger does not expressly disclose:
Wherein an assembly clamps both an entered lead and an exited LLD; and
A module disposed in the assembly configured to apply a twisting action to at least the clamped entered lead whilst the continuous vibration is applied to assist in attempting a drawing out of the lead that is resistant to extraction because of at least affixed vascular adhesions.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Roedger to comprise a clamping element to clamp onto both the entered lead and the exited LLD as doing so would restrict and limit the ability for the cannula (54) to be slid onto and off of the snare during the removal procedure (see Para. [0016]) while remaining in place during tensioning of the snare. To modify the connection between these components would not produce easily predictable results without undue experimentation to ensure the device retained functionality. Further, there would be no functional benefit to clamping the cannula onto the snare and such a modification would not be undertaken without an express reason or benefit since the resulting modification would change the interaction between the cannula and the snare, resulting in a change in the lead removal mechanism. Additionally, while the application of a twisting force is known in the art to aid in lead extraction (see US 2014/0142594 Para. [0003]-[0008]; US 2016/0374721 A1 Para. [0079]; US 2017/0333016 A1 Para. [0117]; US 2015/0366585 A1 Para. [0043]-[0046]; and US 2020/0352552 A1 Para. [0313]-[0314]), none of the prior art indicates an express benefit to why twisting of the lead is superior to applying tension and vibrational energy thereto and would require substantial redesign of the extraction mechanism of the device of Roedger while achieving the same result already present in the disclosure of Roedger. Such a modification would entirely change the functioning of the extraction mechanism without any benefit over the currently disclosed method without a reasonable expectation of success in the effectiveness of the resulting modification.
Claims 8-12 are also conditionally allowable pending resolution to the above 112(b) rejection(s) due to their dependency and further modification of claim 7.
Regarding claim 13, the closest prior art, namely Roedger, discloses:
An apparatus (see Fig. 1) comprising a lead extraction assistance device (apparatus 50, see Figs. 1-3) for use with a lead locking device (LLD)(snare 55, see Figs. 1-3) in a lead extraction procedure (see Para. [0012]-[0013]), the apparatus comprising:
a lead locking device (LLD) (snare 55, see Figs. 1-3);
a lead locking assist device (sheath 60 and subcomponents housed therein, see Figs. 1-3) coupled to the LLD wherein the lead locking assist device comprises:
an assembly configured with a center shaft (cannula 54, see Figs. 1-3) that has an inlet for entry of the lead (see Fig. 5) and configured with an outlet for exit of the LLD (see Figs. 1-3);
a mechanism having a vibration source (vibration generator 30, see Fig. 1) and configured to applying an a vibration to the central shaft and the entered lead (see Para. [0011]-[0016]).
However, Roedger does not expressly disclose:
Wherein an assembly clamps both an entered lead and an exited LLD; and
a module disposed in the assembly configured to apply about the center shaft, a first action by a rotational motor to twist at least a clamped entered lead and a second action by a hammering device to impact the clamped entered lead and wherein the continuous vibration is applied during application of either the first action by the rotational motor of twisting the clamped entered lead or the second action by the hammering device of impacting the clamped entered lead to assist to draw out the lead and counter any resistance caused by affixed vascular adhesions during the lead extraction procedure.
It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Roedger to comprise a clamping element to clamp onto both the entered lead and the exited LLD as doing so would restrict and limit the ability for the cannula (54) to be slid onto and off of the snare during the removal procedure (see Para. [0016]) while remaining in place during tensioning of the snare. To modify the connection between these components would not produce easily predictable results without undue experimentation to ensure the device retained functionality. Further, there would be no functional benefit to clamping the cannula onto the snare and such a modification would not be undertaken without an express reason or benefit since the resulting modification would change the interaction between the cannula and the snare, resulting in a change in the lead removal mechanism. Additionally, while the application of a twisting force and hammering force are known in the art to aid in lead extraction (see US 2014/0142594 Para. [0003]-[0008]; US 2016/0374721 A1 Para. [0079]; US 2017/0333016 A1 Para. [0117]; US 2015/0366585 A1 Para. [0043]-[0046]; and US 2020/0352552 A1 Para. [0313]-[0314]), none of the prior art indicates an express benefit to why twisting or hammering of the lead is superior to applying tension and vibrational energy thereto and would require substantial redesign of the extraction mechanism of the device of Roedger while achieving the same result already present in the disclosure of Roedger. Such a modification would entirely change the functioning of the extraction mechanism without any benefit over the currently disclosed method without a reasonable expectation of success in the effectiveness of the resulting modification.
Claims 14-20 are also conditionally allowable pending resolution to the above 112(b) rejection(s) due to their dependency and further modification of claim 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 10952785 B2, US 10525261 B2, US 2019/0175206 A1, US 2017/0105762 A1, US 2015/0057671 A1, US 2011/0106099 A1, US 2008/0071341 A1, US 5620451 A, US 4582056 A, US 4576162 A, US 2024/0252208 A1, US 2023/0381502 A1, US 2023/0190315 A1, US 2021/0068867 A1, US 2018/0133464 A1, US 9694185 B2, US 2014/0142594 A1, US 6512959 B1 and US 2006/0155352 A1 all disclose lead extraction or implantation devices comprising a central shaft configured to apply either a twisting, vibrational or impacting motion to a captured lead for either extraction or implantation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached at 5712724695. 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.
/M.B.H./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771