DETAILED ACTION
This Office Action is in response to the communication dated 12 January 2026 concerning Application No. 16/702,880 filed on 04 December 2019.
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 .
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 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.
Status of Claims
Claims 27-35 and 37-47 are pending and currently under consideration for patentability; claims 27, 33, and 39 have been amended; claims 1-26 and 36 have been cancelled; claims 40-47 have been added as new claims.
Response to Arguments
Applicant’s arguments dated 12 January 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claim to recite a leadless implantable medical device configured to be implanted in a chamber of the heart, wherein the body of the fixation antenna is configured to penetrate cardiac tissue to affix the LIMD to cardiac tissue in a chamber of the heart. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that “while Schugt describes a fixation mechanism functioning as an antenna of the IMD, Schugt teaches a very different fixation structure that Schugt teaches as necessary in order to serve the dual purpose of fixation and antenna” (Arguments, p. 8). Applicant concludes that “any proposed modification of Fishler would necessarily include a motivation for the person of skill to make a tissue penetrating anchor also serve as the antenna” (Arguments, p. 8). The Examiner respectfully submits that, even though there may be differences between the structure described by Schugt and the structure resulting from an obvious modification of the Fishler reference as proposed by the Examiner, Schugt nonetheless describes that a fixation mechanism may function as an antenna. In its simplest form, the Examiner’s contention is that Fishler describes an implantable medical device comprising a fixation mechanism and an antenna, and Schugt describes that a fixation mechanism may function as antenna. As a result, the Examiner respectfully maintains that the combination of Fishler and Schugt suggests that the antenna function already described by Fisher may be incorporated into the structure of the fixation mechanism, which again is already described by Fisher. The Examiner respectfully maintains that the motivation to incorporate the antenna function into the fixation structure is provided by the Schugt reference itself.
Regarding the incorporation of the Von Arx reference, Applicant argues that “changing the length of Fishler’s fixation screw introduces a significant health consideration and risk”, concluding that “the proposed modification is not merely the academic or theoretical "tuning" of any antenna,” as “this change could result in substantial harm to the patient.” The Examiner respectfully submits that the skilled artisan would be motivated to ensure that any modification to the length of Fishler’s antenna takes into account patient safety. Although Applicant points out one specific example from Von Arx in which the antenna, when housed within the heading of an implantable medical device and folded or twisted into position, may be 8 centimeters to 16 centimeters in length, the Examiner respectfully submits that the skilled artisan would be well aware that an elongated 8-16 centimeter long antenna would not be used to replace Fishler’s fixation mechanism. Rather, the skilled artisan would be motivated to use Von Arx’s teaching that the total length of the fixation mechanism, even when in a twisted or helical configuration, may be modified based on the carrier frequency of the communication means. Incorporating that feature into the fixation mechanism described by the modified Fishler reference results in a structure similar to that recited in the pending claims.
Claim Objections
Claim 37 is objected to because of the following informality.
Claim 37 contains a minor typographical error.
Claim 37, line 1: Applicant is advised to change “the method of claim 36” to “the method of claim 27”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 27-35 and 37-47 are rejected under 35 U.S.C. 103 as being unpatentable over Fishler et al. (US 2016/0121128 A1) in view of Schugt et al. (US 2013/0085350 A1) and Von Arx et al. (US 2009/0192574 A1)
Regarding claim 27, Fishler describes a method for providing a leadless implantable medical device configured to be implanted in a chamber of the heart ([0033] - [0034]) comprising
providing a device housing (110, 202) having electronic circuits therein (figure 2)
disposing an electrode (108a, 108b) on the housing ([0076]; figure 3)
disposing a fixation mechanism 205 on a distal end of the housing (figure 3), the body of the fixation mechanism configured to penetrate cardiac tissue to affix the LIMD to the cardiac tissue in the chamber of the heart ([0076], [0081])
Regarding claim 27, although Fishler describes a fixation mechanism, Fishler does not explicitly disclose a fixation antenna, “the body of the fixation antenna being configured for operation as an antenna to communicate with an external device, wherein the body of the fixation antenna has a predetermined length to tune the fixation antenna to a communication frequency.” Fishler does, however, describe that leadless pacemakers may “communicate with one another, with an ICD 106, and with an external device (programmer) 109 through wireless transceivers, communications coils and antenna, and/or by conductive communication through the same electrodes as used for sensing and/or delivery of pacing therapy” ([0035], emphasis added). Therefore, the Examiner respectfully submits that Fishler suggests that the leadless pacemaker may contain an antenna to communicate with an external device. Specifically regarding the configuration of the fixation mechanism as a “fixation antenna,” the Examiner respectfully directs Applicant to the reference of Schugt. Schugt also describes a leadless implantable medical device ([0025]) with a pacing electrode ([0027]) and fixation mechanism ([0022]), including wherein the fixation mechanism is a fixation antenna disposed on a distal end of the housing and configured for operation as an antenna to communicate with an external device ([0020], [0031]). As Schugt is also directed towards a leadless implantable medical device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a fixation antenna, similar to that described by Schugt, when using the device and fixation mechanism described by Fishler, as doing so advantageously allows the resulting mechanism to operate as both a fixation means and an antenna means, leading to an overall more efficient design. Fishler in view of Schugt therefore suggests the claimed device with the exception of not explicitly disclosing that the antenna includes a body that extends between a proximal end and a distal end and that the antenna has a predetermined length extending between the proximal and distal ends to tune the fixation antenna to a communication frequency. However, Von Arx also describes antennas for implantable medical devices ([0006]), including wherein such an antenna may have a body that extends between a proximal end and a distal end and a predetermined length extending between the proximal and distal ends to tune the fixation antenna to a communication frequency, wherein the predetermined length of the body is defined based on a wavelength of a carrier frequency for communication ([0017] - [0018]) with an external device ([0012]). As Von Arx is also directed towards implantable medical devices and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the fixation antenna described by Fishler and Schugt such that its length was tuned to a communication frequency, as described by Von Arx, as doing so advantageously allows the resulting antenna to more effectively communicate with the external device or other implanted devices.
Regarding claim 28, Fishler describes connecting a feedthrough assembly 212 to the device housing ([0079]; figure 3) and connecting the electrode and fixation mechanism to the feedthrough assembly ([0079]; figure 3).
Regarding claim 29, Fishler describes wherein the electrode is disposed on a distal portion of the housing (figure 3).
Regarding claim 30, Von Arx describes tuning the antenna to communicate in accordance with a MICS protocol (claims 11, 13, 21).
Regarding claim 31, Von Arx describes setting the length of the fixation antenna to be a multiple of a wavelength for a frequency for 400 MHz ([0017]: “carrier frequencies between 300 MHz and 1 GHz are most desirable”; please see ranges of “approximately 402 MHz to approximately 405 MHz” corresponding to a MICS protocol in claims 11, 13, 21).
Regarding claim 32, Fishler in view of Schugt and Von Arx suggests the method of claim 27. Fishler, Schugt, and Von Arx do not explicitly disclose forming the fixation antenna of a material having a deflection DEF = LENREST/LENEXTEND that is no more than 50%, wherein LENREST represents a rest length of the fixation antenna along the longitudinal axis when in a rest non-extended state and LENEXTEND represents an extended length of the fixation antenna along the longitudinal axis when deflected to a fully extended state. However, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the fixation antenna with the proper materials and windings in order to achieve a certain deflection, as doing so would be a matter of changing the size, shape, and/or proportion of a known element without materially affecting the function of the overall device, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04).
Regarding claim 33, Fishler describes wherein the fixation mechanism is electrically separate from the electrode and partially disposed on a distal portion of the housing ([0076]), the fixation mechanism being electrically coupled to a transceiver circuit ([0035]). Schugt describes wherein the fixation antenna is configured to operate as an antenna for communication between a transceiver circuit and an external device ([0020], [0031]).
Regarding claim 34, Schugt describes wherein the housing includes a feedthrough ([0059]), the fixation antenna including the proximal end connected through the feedthrough to a transceiver circuit ([0048], the fixation mechanism and connector may be a one-piece structure connected via the feedthrough to the electrical circuitry; [0083]). Fishler describes the fixation mechanism having a distal end that is electrically open (figure 3).
Regarding claim 35, Von Arx describes wherein the fixation antenna is configured to operate as a monopole antenna for communication between the transceiver circuit and the external device ([0014]).
Regarding claim 37, Von Arx describes wherein the length of the body is a quarter multiple of the wavelength of the carrier frequency ([0014]).
Regarding claim 38, Fishler describes shaping the body of the fixation mechanism as a helix ([0076], figure 3).
Regarding claim 39, Fishler in view of Schugt and Von Arx suggests the method of claim 27, including wherein the body of the fixation mechanism is shaped as a helix and has less than five turns of rotation from the distal end to the proximal end to provide the fixation mechanism with the predetermined length and to decrease a change of the LIMD dislodging (Fishler: figure 3, [0076]). Fishler, Schugt, and Von Arx do not explicitly disclose wherein the fixation antenna has a diameter between 2.5 mm and 5 mm. Schugt does, however, describe that the diameter of the fixation antenna may be modified as desired in order to place the resulting device in the proper location ([0057]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure fixation antenna such that it had a diameter between 2.5 mm and 5 mm, as doing so would be a matter of changing the size, shape, and/or proportion of a known element without materially affecting the function of the overall device, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04).
Regarding claim 40, Fishler describes wherein the body of fixation antenna is shaped as a helix that partially surrounds or rotates about a longitudinal axis of the device housing (figure 3, [0076]), the helix having a diameter that is less than or equal to an outer diameter of the device housing to provide the fixation antenna with the predetermined length (figure 3, [0076], [0081]) and still decrease a chance of the LIMD from coming dislodged ([0076]).
Regarding claims 41 and 42, Fishler describes wherein the body of the fixation mechanism is shaped as a helix. Although Fishler, Schugt, and Von Arx do not explicitly disclose wherein the fixation antenna has a diameter of at least 2.5 mm or multiple coils with a pitch of at least 0.5 mm, the Examiner respectfully submits that, as Schugt describes that the diameter of the fixation antenna may be modified as desired in order to place the resulting device in the proper location ([0057]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure fixation antenna such that it had a diameter of at least 2.5 mm or multiple coils with a pitch of at least 0.5 mm, as doing so would be a matter of changing the size, shape, and/or proportion of a known element without materially affecting the function of the overall device, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04).
Regarding claim 43, Fishler describes wherein the body of the fixation antenna is shaped to include multiple coils spaced apart from one another by gap (figure 3). Although Fishler, Schugt, and Von Arx do not explicitly disclose wherein the gap is sufficient to prevent electrical shorts between adjacent coils, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to ensure such a feature, as doing so advantageously enhances patient safety when using the device.
Regarding claim 44, Fishler describes wherein the fixation antenna is configured to be affixed to a tissue wall of a right ventricle along a septum that divides the right ventricle from a left ventricle or a right atrium along a septum that divides the right atrium from a left atrium ([0210]).
Regarding claim 45, Fishler in view of Schugt and Von Arx suggests the method of claim 44, including wherein the body of the fixation mechanism is shaped as a helix and has less than five turns of rotation from the distal end to the proximal end to provide the fixation mechanism with the predetermined length and to decrease a change of the LIMD dislodging (Fishler: figure 3, [0076]). Fishler, Schugt, and Von Arx do not explicitly disclose wherein the fixation antenna has a diameter between 2.5 mm and 5 mm. Schugt does, however, describe that the diameter of the fixation antenna may be modified as desired in order to place the resulting device in the proper location ([0057]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure fixation antenna such that it had a diameter between 2.5 mm and 5 mm, as doing so would be a matter of changing the size, shape, and/or proportion of a known element without materially affecting the function of the overall device, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04).
Regarding claim 46, Fishler describes wherein the body of fixation antenna is shaped as a helix that partially surrounds or rotates about a longitudinal axis of the device housing (figure 3, [0076]), the helix having a diameter that is less than or equal to an outer diameter of the device housing to provide the fixation antenna with the predetermined length (figure 3, [0076], [0081]) and still decrease a chance of the LIMD from coming dislodged ([0076]).
Regarding claim 47, Fishler describes wherein the body of the fixation mechanism is shaped as a helix. Although Fishler, Schugt, and Von Arx do not explicitly disclose wherein the fixation antenna has a diameter of at least 2.5 mm, the Examiner respectfully submits that, as Schugt describes that the diameter of the fixation antenna may be modified as desired in order to place the resulting device in the proper location ([0057]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure fixation antenna such that it had a diameter of at least 2.5 mm, as doing so would be a matter of changing the size, shape, and/or proportion of a known element without materially affecting the function of the overall device, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792