The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 1-2, 9 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dorr et al. (WO 2021/083792, which has corresponding US Patent Pub. No. 2022/0362546).
Dorr discloses an implantable medical device comprising an anchoring device (see Title). Specifically, Dorr teaches a biostimulator (see page 1, lines 12-15 for teaching “an electrode device for at least one of emitting an electrical stimulation signal…), comprising:
A housing having a longitudinal axis and containing pacing circuitry in an electronics compartment (“Referring now to Fig. 3, in one embodiment an implantable medical device 1 in the shape of a leadless pacemaker device 15 comprises a body [100/]150 in the shape of a housing which extends longitudinally along a longitudinal axis L and encapsulates components of the leadless pacemaker device 15, such as a processing device, a data memory, a battery, pulse generation circuitry and the like to allow for a stimulation operation immediately within the heart” – see page 16, lines 1-6);
A fixation element coupled to the housing (see Abstract, “An implantable medical device (1) for implantation into a patient comprises a body (100, 150), an anchoring device (13) for anchoring the body (100, 150) to tissue at a location of interest, the anchoring device (13) being arranged on the body (100, 150)”); and
A pacing element coupled to the housing, wherein the pacing element is longitudinally movable relative to the fixation element (see page 16, lines 25-28; “an electrode device 14 having a helically extending coil body 142 is arranged on the body 100 to extend from the body 100 at the distal end 101. The electrode device 14 is axially movable along a longitudinal axis L, along which the body 100 generally extends, with respect to the body 100.”).
Regarding claim 2, Dorr illustrates in at least Figures 4, 5, 6A, 6B, and 9 that the fixation element includes a proximal helix extending about the longitudinal axis to a first helix tip, and wherein the pacing element includes a distal helix extending about the longitudinal axis to a second helix tip.
Regarding claim 9, Dorr teaches that “With its electrode 140, hence, the electrode device 14 may come into engagement with tissue in order to electrically couple to tissue for emitting electrical stimulation signals into and/or receiving electrical sense signals from tissue” (see page 17, lines 24-26). Therefore, it is clear that since the electrode 14 is used “for emitting electrical stimulation signals and/or receiving electrical sense signals from tissue”, it is inherently coupled to the pulse generator mentioned on page 16, lines 1-6 of the leadless pacemaker.
Regarding claim 16, Dorr teaches that its device is to be brought into a particular target area, for example on the septum of the heart (see page 4, lines 18-28). Additionally, the biostimulator of Dorr includes a housing having a longitudinal axis and containing pacing circuitry in an electronics compartment (“Referring now to Fig. 3, in one embodiment an implantable medical device 1 in the shape of a leadless pacemaker device 15 comprises a body [100/]150 in the shape of a housing which extends longitudinally along a longitudinal axis L and encapsulates components of the leadless pacemaker device 15, such as a processing device, a data memory, a battery, pulse generation circuitry and the like to allow for a stimulation operation immediately within the heart” – see page 16, lines 1-6),
a fixation element coupled to the housing (see Abstract, “An implantable medical device (1) for implantation into a patient comprises a body (100, 150), an anchoring device (13) for anchoring the body (100, 150) to tissue at a location of interest, the anchoring device (13) being arranged on the body (100, 150)”), and
a pacing element coupled to the housing, wherein the pacing element is longitudinally movable relative to the fixation element (see page 16, lines 25-28; “an electrode device 14 having a helically extending coil body 142 is arranged on the body 100 to extend from the body 100 at the distal end 101. The electrode device 14 is axially movable along a longitudinal axis L, along which the body 100 generally extends, with respect to the body 100.”); and
the method of Dorr includes advancing the fixation element of the biostimulator into the septal wall of the heart (see Figure 4 illustrates the leadless pacemaker of Dorr with fixation element 13 having been advanced into the septal wall of the heart).
Regarding claim 17, Dorr teaches the following at page 17, line 28 through page 18, line 3:
The electrode device 14, as apparent from Figs. 6A and 6B, may be moved in between different positions with respect to the housing element 105 of the body 100. In a retracted position, shown in Fig. 6A, the electrode device 14 fully or at least with substantial portions is received within the housing element 105, such that the electrode device 14 does not or only with a portion extends from the housing element 105. By rotating the inner conductor 103 the electrode device 14 may be moved out of the housing element 105, as this is shown in Fig. 6B, in order to bring the electrode device 14 into engagement with tissue at a location of interest.
Dorr teaches the following at page 18, line 25 through page 19, line 2:
This allows to screw the anchoring device 13 into tissue in the sense of rotation R1, while the electrode device 14 is in its retracted position according to Fig. 6A. Once the body 100 with its distal end 101 is coupled to tissue by means of the anchoring device 13, the electrode device 14 may be screwed into tissue in the sense of rotation R2, which causes a load on the anchoring device 13 in the sense of rotation R1 such that the anchoring by means of the anchoring device 13 is tightened rather than loosened when screwing the electrode device 14 into tissue for bringing the electrode 140 into a position in which an effective coupling to tissue is established.
Regarding claim 18, it can be seen from the quote immediately above that rotation R2 causes the electrode device 14 to be screwed into the patient tissue. Therefore, it is inherent that rotation in the opposite direction will result in removal of the electrode from patient tissue.
Regarding claim 19, Dorr illustrates in at least Figures 4, 5, 6A, 6B, and 9 that the fixation element includes a proximal helix extending about the longitudinal axis to a first helix tip, and wherein the pacing element includes a distal helix extending about the longitudinal axis to a second helix tip.
Claim Rejections - 35 USC § 103
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.
Claims 3-6, 13-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dorr in view of Shuros et al. (US Patent Pub. No. 2018/0050208), in view of Parker (US Patent Pub. No. 2009/0306754).
Dorr is described above with respect to claims 1, 11 and 16. While Dorr teaches that the pacing element (i.e., electrode device 14) is extendible, it is not taught as extending via telescopic means.
Regarding claims 3, 13 and 20, Shuros teaches “An implantable medical device (IMD) includes a housing that is configured to be positioned at least in part in a chamber of a heart” (see Abstract; see device of Figure 6). “[T]he IMD 20 may include an LV electrode position adjustment assembly 40 that is schematically shown in FIG. 2. The LV electrode position adjustment assembly 40 may, as will be shown with respect to subsequent Figures, be adjustable in length in order to adjust the position of the LV electrode 36 relative to the housing 22 and thus adjust the relative depth to which the LV electrode 36 penetrates within the ventricular septum 10” (see paragraph 54). As described in paragraph 55, “the LV electrode position adjustment assembly 40 may include a threaded mechanism that when rotated causes the LV electrode 36 to move outward to penetrate further into the ventricular septum 10.” However, paragraph 55 also states that “In some cases, the LV electrode position adjustment assembly 40 may telescope and thus may assume a shorter profile in the retracted position.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a telescoping position adjustment mechanism, as taught by Shuros, within the system and methods of Dorr, because this would allow for a shorter profile in the retracted position, which would allow for a shorter overall profile of a leadless pacemaker.
However, Shuros does not explicitly teach one or more stages telescopically movable relative to each other such that the distal pedestal is longitudinally movable relative to a proximal pedestal end.
Parker teaches a telescoping electrode assembly (see Abstract). “FIGS. 2A-B provide partial views of a telescoping electrode assembly 200 comprising a plurality of telescoping sections 210, 220, 230 nested together in a retracted state (FIG. 2A) and expanded in a deployed state (FIG. 2B)” (see paragraph 30). “FIGS. 5A-C illustrate an exemplary method of deploying a telescoping electrode assembly in which the telescoping sections are deployed out of the nested configuration one section at a time” (see paragraph 41). “FIGS. 6A-C illustrate another method of deploying a telescoping electrode assembly 600 in which the telescoping sections 610, 620, 530 are deployed simultaneously” (see paragraph 44). Figures 9A-B also illustrate a telescoping assembly including eleven (11) nested telescoping sections.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the use of telescoping position adjustment as taught by Shuros would include multiple telescoping sections including at least a proximal section and a distal section movable relative to one another, as illustrated by Parker, since it is known that extension by telescoping means at least two sections nested within one another, and Parker illustrates this concept within an electrical stimulation device.
Regarding claims 4 and 14, each figure of Parker mentioned above illustrates at least a distal pedestal and a proximal pedestal (e.g., see distal section 610 and proximal section 630 in Figures 6A-C).
Regarding claims 5 and 15, it can be seen in Figures 6A-C of Parker that the profiles of these sections are rectangular.
Regarding claim 6, as shown in Figure 2 of Shuros, there is a conductor 38 that extends from the circuitry 26 to the electrode 36. This lead would also extend through the position adjustment assembly 40 of Shuros when it comprises the telescope version of mentioned by Shuros.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dorr in view of Shuros and Parker as applied to claim 3 above, and further in view of Onik et al. (TW 201735951).
Dorr in combination with Shuros and Parker is described above with regard to claim 3.
In a first manner of rejection, Shuros teaches a conductor 38 extends from the circuitry to the LV electrode (see Figure 2). Shuros is silent with regard to whether or not this conductor comprises an insulative layer or whether an interior of LV electrode position adjustment assembly 40 (see Figure 2 again) comprises an electrically insulative layer on its interior. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that one of those two options would be utilized to insulate the electrical energy passing through the conductor 38. As such, the use of either one to construct the system taught by Shuros would amount to choosing from a finite number of insulative methodologies available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
In a second manner of rejection, however, Onik teaches a having two electrically insulating layers 522, 524, which are telescopically provided within one another along with electrical conductors to provide electrical stimulation to a target region. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide insulative layers along pathways of electrical current to provide safety for a patient and doctors alike, so as to prevent undesirable shock and electrocution.
Claims 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Dorr in view of Eggens (US Patent Pub. No. 2014/0324145).
Dorr is described above with respect to claims 1 and 9. However, Dorr does not teach that the anchoring device 13 stimulates and/or senses, or that it is coupled to any pacing circuitry (as in claim 10), nor an attachment feature at the end of the housing opposite the fixation and pacing elements (as in claim 8).
Regarding claim 8, Eggens teaches “implantable medical devices (e.g., cardiac pacemakers), electrode assemblies thereof, and fixation members for the electrode assemblies” (see paragraph 3). Figures 2A and 2B illustrate the fixation members 230 along with electrode 210. “With reference back to FIG. 2A, according to some embodiments, device 200 includes a notch 205, which is formed in proximal portion 202 and configured for engagement with a screw-driver type stylet” (see paragraph 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a notch, as taught by Eggens, in the leadless pacemaker device of Dorr as one option for engaging the device of Dorr with the patient’s tissue, as the device needs to be controlled during delivery by some delivery system under control of the doctor.
Regarding claim 10, Eggens teaches “implantable medical devices (e.g., cardiac pacemakers), electrode assemblies thereof, and fixation members for the electrode assemblies” (see paragraph 3). Figures 2A and 2B illustrate the fixation members 230 along with electrode 210. Both of these structures are helical shapes. “It should be noted that, according to some embodiments, an electrode surface may be formed on one or both of fixation members 230 to function as a bipolar pace-sense pair with the above-described electrode surface formed on helical structure 210” (see paragraph 22). Therefore, it is inherent that in this embodiment of Eggens, the members 230 would be coupled with a pacing circuit that is used to deliver pacing stimulation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize helical anchoring/fixation members in coordination with the electrode of a leadless pacemaker, as is taught by Eggens, within the system and methods of Dorr, because “such a pace-sense pair may be advantageous in some instances… when device 200 is implanted in the right atrium RA for pacing function based on P-wave sensing, since the closer spacing between the electrode surface of helical structure 210 and that of one or both of fixation members 230 is less susceptible to far-field R-wave sensing” (see paragraph 22 of Eggens).
Regarding claim 11, Figure 3 of Eggens illustrates a delivery device 300 (equated to “a biostimulator transport system”), and a biostimulator mouted on the biostimulator transport system (see device 200 mounted on the end of the transport system 300).
Dorr teaches a biostimulator (see page 1, lines 12-15 for teaching “an electrode device for at least one of emitting an electrical stimulation signal…) that includes a housing having a longitudinal axis and containing pacing circuitry in an electronics compartment (“Referring now to Fig. 3, in one embodiment an implantable medical device 1 in the shape of a leadless pacemaker device 15 comprises a body [100/]150 in the shape of a housing which extends longitudinally along a longitudinal axis L and encapsulates components of the leadless pacemaker device 15, such as a processing device, a data memory, a battery, pulse generation circuitry and the like to allow for a stimulation operation immediately within the heart” – see page 16, lines 1-6),
a fixation element coupled to the housing (see Abstract, “An implantable medical device (1) for implantation into a patient comprises a body (100, 150), an anchoring device (13) for anchoring the body (100, 150) to tissue at a location of interest, the anchoring device (13) being arranged on the body (100, 150)”), and
a pacing element coupled to the housing, wherein the pacing element is longitudinally movable relative to the fixation element (see page 16, lines 25-28; “an electrode device 14 having a helically extending coil body 142 is arranged on the body 100 to extend from the body 100 at the distal end 101. The electrode device 14 is axially movable along a longitudinal axis L, along which the body 100 generally extends, with respect to the body 100.”).
As with the combination of Dorr with Eggens as described above with respect to claim 8, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a notch, as taught by Eggens, in the leadless pacemaker device of Dorr as one option for engaging the device of Dorr with the patient’s tissue, as the device needs to be controlled during delivery by some delivery system under control of the doctor.
Regarding claim 12, Dorr illustrates in at least Figures 4, 5, 6A, 6B, and 9 that the fixation element includes a proximal helix extending about the longitudinal axis to a first helix tip, and wherein the pacing element includes a distal helix extending about the longitudinal axis to a second helix tip.
Conclusion
See additional prior art listed on the Notice of References cited, which teach at least one of leadless pacemakers and/or electrical stimulation devices having distinct anchoring members and electrodes movable with respect to one another, or telescoping features used for providing elongation and repositioning of electrodes or electrode structures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p 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.
/JAMES KISH/ Primary Examiner, Art Unit 3792