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
The 35 USC § 112 rejections have been withdrawn for claims 5 and 9 as the applicant has amended the claims to address the rejections.
The arguments directed towards the prior art are now moot in view of the new grounds of rejection necessitated by the applicant’s claim amendments.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 2/26/2026 is acknowledged.
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.
Claim(s) 1, 3, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher et al. (Pub. No.: US 2009/0192555 A1); hereinafter referred to as “Schleicher”, in view of Tranchina et al. (Pub. No.: US 2018/0221672 A1); hereinafter referred to as “Tranchina”.
Regarding claim 1, Schleicher discloses a pacemaker device (e.g. see figures 1 and figures 14-17, element 100, [0032]. Note: A pacemaker is a type of implantable pulse generator), comprising: a cylindrical shell (e.g. see figures 1 and 14-17, element 105, [0032]) having a first end and a second end, and an elongated flattened side (e.g. see flat side of element 100 in figures 1 and 14-17) which extends from the first end to the second end; a flat electrode (e.g. see figures 1 and 14-17, element 110, [0032]) surface positioned on the flattened side; and a pair of flexible wings (e.g. see figures 14-17 elements 1425 and 1625) that project laterally and parallel to a first portion of the flattened side when the flexible wings are in a deployed position adjacent to an epicardial surface, wherein: the flexible wings are located on opposite sides of the first portion of the flattened side of the cylindrical shell (e.g. see figures 14-17 elements 1425 and 1625): the flexible wings are configured to be furled inside a sleeve that covers the first portion of the elongated flattened side of the cylindrical shell so that the flexible wings extend over the first portion of the elongated flattened side when the pacemaker is being inserted to be placed adjacent to the epicardial surface (e.g. see [0070]-[0071]. See [0071], element 1400 for the “sleeve”) and the flexible wings are configured to be deployed laterally outward from the flattened side into the deployed position to prevent axial rolling of the pacemaker when the sleeve is removed and the pacemaker is placed adjacent to the epicardial surface (e.g. see [0070]-[0071]. Note: [0070] discloses “The improved fixation can reduce the likelihood that casing 105 of an implantable pulse generator 100 shifts after implantation”. Regarding the “epicardial surface”, that is a functional use limitation of a system claim that the prior art is capable of and/or configured to perform).
Schleicher discloses the electrodes on the flat side (e.g. see figures 1 and 14-17, element 110, [0032]) but is silent as to the electrodes on the flat side functioning as a cathode to the pacemaker device. Tranchina teaches it is known to use such a modification as set forth in [0069]-[0070] to provide any combination of cathodes and anodes (as long as there is at least one cathode and at least one anode) thereby providing different shaped current fields (e.g. see [0069]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the electrodes in Schleicher as either cathodes or anodes as taught by Tranchina, since said modification would provide the predictable results of any combination of cathodes and anodes (as long as there is at least one cathode and at least one anode) thereby providing different shaped current fields.
Regarding claim 3, Schleicher discloses one or more elongated spikes protruding from the flattened side, which provide an anti-sliding resistance force between the pacemaker and the epicardial surface (e.g. see figures 6 and 7, element 605, [0042]-[0045]. Note: The limitations directed towards the human anatomy are functional use limitations of a system claim that the prior art is capable of and/or configured to perform).
Regarding claim 32, Schleicher discloses the first end is a leading end of the pacemaker, and the first portion of the flattened side is located adjacent to the first end (e.g. see figures 1 and 14-17).
Regarding claim 33, Schleicher discloses a textured surface on the first portion of the flattened side to increase adhesion to the epicardial surface (e.g. see figures 6 and 7, element 605, [0042]-[0045]. Note: The limitations directed towards the human anatomy are functional use limitations of a system claim that the prior art is capable of and/or configured to perform).
Regarding claim 34, Schleicher discloses one or more elongated spikes protruding from a second portion of the flattened side, which spikes provide an anti- sliding resistance force between the pacemaker and the epicardial surface, wherein the second portion is located between the first portion and the flat electrode surface (e.g. see figures 6 and 7, element 605, [0042]-[0045]. Note: The limitations directed towards the human anatomy are functional use limitations of a system claim that the prior art is capable of and/or configured to perform).
Regarding claim 35, Schleicher discloses the second portion of the flattened side is a smooth surface (e.g. see figures 1 and 14-17).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schleicher and Tranchina as applied to claim 1, and further in view of Swackhamer et al. (US 2017/0050028) (hereinafter Swackhamer).
Regarding claim 2, Schleicher and Tranchina do not teach a textured surface on at least some portion of the flattened side to increase adhesion to an epicardial surface. Swackhamer, however, teaches an implantable medical device with modified surface texture (Abstract) wherein the IMD comprises a cardiac pacemaker (para. 4) and includes a textured surface on at least some portion of a surface to increase adhesion to a cardiac surface (para. 53: “FIGS. 2 through 8 provide illustrative but non-limiting examples of surface texture patterns that may be formed in or on the outer housing surface 28 in order to influence the resulting texture of the insulative layer 30 that is disposed over at least a portion of the outer housing surface 28 and thus influence an expected level of endothelial cell growth”). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Schleicher and Tranchina to include a textured surface on at least some portion of the flattened side to increase adhesion to an epicardial surface. Making this modification would be useful for influencing an expected level of cardiac cell growth, as taught by Swackhamer.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher and Tranchina as applied to claims 1 and 3, and further in view in view of Muessig et al. (US 2021/0069516) (hereinafter Muessig).
Regarding claim 4, Schleicher and Tranchina do not teach one or more of the elongated spikes functions as an anode for the pacemaker device. Muessig, however, teaches a leadless pacemaker (Abstract) wherein the fixation element includes at least one hook for fixating the leadless pacemaker to the cardiac tissue, wherein the at least one hook is configured to act as a counter electrode, such that a voltage may be applied between the pacing electrode and the at least one hook (para. 23). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Schleicher and Tranchina such that one or more of the elongated spikes functions as an anode for the pacemaker device. Making this modification would be useful such that a voltage may be applied between the pacing electrode and the at least one hook, as taught by Muessig.
Regarding claim 5, Scheicer teaches a smooth surface on the flattened side between the electrodes (e.g. see flat side of element 100 in figures 1 and 14-17) but is silent as to the cathode and the one or more anodes. Tranchina teaches it is known to use such a modification as set forth in [0069]-[0070] to provide any combination of cathodes and anodes (as long as there is at least one cathode and at least one anode) thereby providing different shaped current fields (e.g. see [0069]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the electrodes in Schleicher as either cathodes or anodes as taught by Tranchina, since said modification would provide the predictable results of any combination of cathodes and anodes (as long as there is at least one cathode and at least one anode) thereby providing different shaped current fields.
Claims 6 and 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schleicher and Tranchina as applied to claim 1, and further in view in view of Park et al. (WO 2021/118205) (hereinafter Park).
Regarding claims 6 and 7, Schleicher and Tranchina do not teach an anti-inflammatory drug elutes from the flattened side near the cathode or the anti-inflammatory drug is contained behind the cathode and elutes through perforations in the cathode. Park, however, teaches to an implantable medical device capable of releasing an anti-inflammatory substance and, particularly, to an implantable medical device, which releases anti-inflammatory drugs while inserted in the body, so as to minimize side effects, thereby enabling stable stimulation of an object to be stimulated. The present invention provides the implantable medical device capable of releasing an anti-inflammatory substance through an electrical signal in order to suppress the occurrence of blood clots, the implantable medical device comprising: an electrode unit which has a plurality of release holes for releasing, at the site at which the blood clots occur, solid or liquid drugs containing the anti-inflammatory substance, and which includes a plurality of electrodes for controlling opening/closing of the plurality of release holes by means of the electrical signal; and a control unit which includes a stimulation generating unit for transmitting the electrical signal to the electrode unit, and which controls the operation of the stimulation generating unit so as to control release of the drugs. According to the present invention, stimulation efficiency can be increased by removing, with a small amount of anti-inflammatory drugs, encapsulation caused by fibrous tissue formed as resistance to electrical stimulation (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Schleicher and Tranchina such that the anti-inflammatory drug is contained behind the cathode and elutes through perforations in the cathode. Making this modification would be useful for minimizing side effects, enabling stable stimulation of an object to be stimulated, suppressing the occurrence of blood clots, and increasing stimulation efficiency, as taught by Park.
Claims 9 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher and Tranchina as applied to claims 1, 3, and 32-35, and further in view in view of Sinnott (US 2020/0069938).
Regarding claims 9 and 36, Schleicher and Tranchina do not teach a pulley in one end of the shell to accommodate a removable string whereby the pacemaker device is withdrawn during an insertion procedure. It is noted that Applicant discloses the claimed “pulley” as being a loop on one end of the pacemaker which accommodates a string (see instant application Figs. 2A-B & 3B, pulley 127 and string 188). Examiner thus interprets any structure of a pacemaker capable of accommodating a string as being a “pulley” as claimed by Applicant. Sinnott teaches a leadless pacemaker (Abstract) including a deployment and retrieval knob 164 on one end of the pacemaker (see Figs. 8A-B; considered a pulley) containing two entities labeled as 165 which are known as the string loop holes. The string loop holes are connected and allow for a loop of string to maintain control of the linear leadless pacemaker during deployment and assessment of position (para. 94). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Schleicher and Tranchina to include a pulley in one end of the shell to accommodate a removable string whereby the pacemaker device is withdrawn during an insertion procedure. Making this modification would be useful for maintaining control of the leadless pacemaker during deployment and assessment of position, as taught by Sinnott.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schleicher and Tranchina as applied to claim 1, and further in view in view of Munshi et al. (US 5411537) (hereinafter Munshi).
Regarding claim 10, Schleicher and Tranchina do not teach a rechargeable power supply. Munshi, however, teaches an improved hermetically-sealed automatic implantable cardioverter-defibrillator (AICD) or any other bioimplantable device which may be operated on a single rechargeable cell, or a dual power source system, the rechargeable component being recharged by magnetic induction. The batteries are based on lithium chemistries specially designed to yield higher currents than conventional primary lithium chemistries and to permit long-term performance despite sub-capacity recharging (Abstract). Col. 4, ll. 20-57 lists many advantages of the rechargeable battery-operated system. It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Schleicher and Tranchina to include a rechargeable battery supply. Making this modification would be useful for yielding higher currents than conventional primary lithium chemistries and to permit long-term performance despite sub-capacity recharging, as well as the many advantages listed in Col. 4, ll. 20-57, as taught by Munshi.
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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 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, Unsu Jung can be reached at 571-272-8506. 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.
/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights