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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Claims 1-14, and Species A1 and B2 in the reply filed on 08/18/2026 is acknowledged.
Applicant’s arguments with traverse of the species restriction between Species B2 and B3, i.e. that the identified Figs. 4 and 5/6 respectively relate to the same embodiment, are persuasive. The election to Species B2 encompasses Figs. 4-6.
Claim Rejections - 35 USC § 102
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 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 1-4, 7, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20180126179 awarded to Haasl et al.
Regarding Claims 1 and 10, Haasl teaches a biostimulator and system, comprising: a biostimulator transport system, and a biostimulator mounted on the biostimulator transport system (Para. 0067, “Further, a measure of the dimension L2 may be substantially equal to or less than a measure of dimension D2 of the housing 22 to facilitate delivery of the IMD 20 through vasculature of the patient, such inside of a delivery catheter”), wherein the biostimulator includes a housing (housing 22) having a longitudinal axis (Fig. 15) and an electronics compartment containing pacing circuitry (Para. 0059, “Circuitry 32 may be disposed at least partially within the housing 22 and may be operably coupled to the power source 30. The circuitry 32 may be operatively coupled to the power source 30, such that the circuitry 32 may draw power from the power source 30. In some cases, the circuitry 32 may be configured to sense the heart H and/or to sense electrical activity of the heart H via one or more electrodes that are exposed outside of the housing 22. Although not shown, the housing may include one or more sensors, such as an ECG sensor, an accelerometer, a gyro, a pressure sensor, a temperature sensor and/or any other suitable sensor. Moreover, in some cases, the circuitry 32 may include communication circuitry for communicating with one or more remotely located devices, such as a leadless cardiac pacemaker (LCP) located elsewhere the heart (e.g. in a ventricle), a subcutaneous implantable cardiac defibrillator (SICD), a remote programmer or any other suitable device.”); an electrode extension extending distally between the housing (tail 60 from housing 22 to electrode 62, Fig. 15) and an electrode (electrode 62); and an expandable frame including a plurality of struts disposed about the longitudinal axis (expandable frame 40, Fig. 15).
Regarding Claims 2 and 12, Haasl teaches the biostimulator of claims 1 and 10, further comprising a header assembly mounted on a distal housing end of the housing (hub 41, Fig. 9, Para. 0097, “In the IMDs 20 of FIGS. 8 and 9 and/or other cases, the housing 22 may engage the hub 41 and/or other portions of the expandable anchoring member 38, where at least part of the housing 22 may releasably engage the hub 41 or other portion of the expandable anchoring member 38 and/or at least part of the housing 22 may fixedly engage the housing 22 or other portion of the expandable member 38. The housing 22 may releasably engage the expandable anchoring member 38 with a releasable engagement including, but not limited to, a threaded engagement, a luer lock engagement, a ball-detent engagement, and/or any other releasable engagement. Alternatively or in addition, the housing 22 may fixedly engage the expandable anchoring member 38 through a welding technique, a brazing technique, a soldering technique, and/or any other technique for fixedly engaging two elements to one another. In one example of engaging the housing 22 with the expandable anchoring member 38, the housing 22 may threadably engage the hub 41 to allow for removal of the housing 22 from the expandable anchoring member 38 after implantation of the IMD 20. Alternatively or in addition, at least part of the housing 22 may fixedly engage the hub 41 and at least part of the IMD 20 may be releasable from the housing 22 (e.g., although not shown in FIGS. 8 and 9, the power source 30 may be releasable from the housing 22 as discussed above with respect to FIGS. 4A and 4B) and/or releasable from the expandable anchoring member 30”), wherein the expandable frame is coupled to the header assembly (Para. 0069, “Further, the hub 41 may be monolithically formed with the expandable members 40 and/or one or more of the expandable members 40 may be affixed to the hub 41. The expandable members 40 may be affixed to the hub 41 in any suitable manner including, but not limited to, welding, brazing, soldering, clasping, and/or using adhesives”).
Regarding Claim 3, Haasl teaches the biostimulator of claim 2, wherein a distal frame end of the expandable frame is proximal to the header assembly Para. 0069, Fig. 15).
Regarding Claims 4 and 13, Haasl teaches biostimulator of claims 1 and 10, wherein the plurality of struts are radially expandable (Fig. 15).
Regarding Claims 7 and 14, Haasl teaches the biostimulator of claim 1 further comprising a second electrode extension (portion of tail 60 extending from electrode 64 to the end of tail 60) extending distally between the housing and a second electrode (electrode 64, Fig. 15).
Regarding Claim 9, Haasl teaches the biostimulator of claim 1 further comprising a retrieval feature mounted on a proximal housing end of the housing (retrieval feature 25, Para. 0062, “In some cases, the housing 22 may include one or more retrieval features, such as a retrieval feature 25. In one example, the retrieval feature 25 may be located at or near the second end 26 of the housing 22, as shown in FIGS. 2A and 2B. Alternatively, the retrieval feature 25 may be located at or near the first end 24, if desired. In some cases, the housing 22 may include no retrieval features, one retrieval feature, two retrieval features, or more than two retrieval features”).
Regarding Claim 11, Haasl teaches the biostimulator system of claim 10, wherein the biostimulator transport system includes a proximal section containing the housing and a distal section containing the electrode extension, and wherein the proximal section has a larger inner dimension than the distal section (Fig. 15, showing that the tail 60 is smaller in diameter than the housing 22).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Haasl as applied to Claim 1 above, and further in view of U.S. Patent Publication 20190192863 awarded to Koop et al.
Regarding Claims 5 and 6, Haasl teaches the biostimulator of claim 1, wherein the plurality of struts have respective free ends (Fig. 15). Haasl does not teach the free ends having respective fixation hooks, or wherein the electrode extension includes a helical tip.
However, in the art of cardiac implanted devices (abstract), Koop teaches fixation struts having hooks on the ends (Para. 0152, “Additional means of anchoring include the use of a plurality of hooks or barbs or graspers to grab the distal wall and baskets, malecots, distal foam plugs and Nitinol wire birds nests that open within the LAA and push outward on the wall or engage the protrusions of the LAA. It may be desirable to place the plug then engage the anchor as a secondary step. One such embodiment could include a multitude of nitinol wires with a ball or catch welded proximal to the anchor tip. These could be gathered with the delivery catheter then released when the ideal plug position has been confirmed”) and the electrode extension having a helical tip, both for the purpose of improving fixation of the device (Para. 0077, “The fixing members 52 may include one or more anchors 54 (e.g., tines, helical coils, talons, or other anchors) made of silicon, a biocompatible polymer, a biocompatible metal, another biocompatible material, a shape memory material (e.g., nitinol or other shape memory material), and/or a bioabsorbable. A bioabsorbable material may be utilized to facilitate removal of the leadless pacing device 20 from a patient as endothelial growth may otherwise occur over the anchors 54. The anchors 54 may extend radially outward from the distal extension 28 and press against the walls of coronary sinus 15. The force between the anchors 54 and the walls of coronary sinus 15 may hold the distal end 50b of the distal extension 28 in place”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haasl by Koop, i.e. by using the hooks and helical tip of Koop in the system of Haasl, for the predictable purpose of providing additional fixation to the system of Haasl to improve the system in the same way as Koop.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Haasl as applied to claim 7 above, and further in view of U.S. Patent Publication 20180250014 awarded to Melanson et al.
Regarding Claim 8, Haasl teaches the biostimulator of Claim 7. Haasl does not teach wherein the second electrode extension includes a barb tip.
However, in the art of implantable cardiac devices (abstract), Melanson teaches a helical tip on the end of an electrode extension to secure the end at the intended target (Para. 0181, “Another means of anchoring the distal anchor element to the foam is shown in FIG. 26. Two barbed leads 2604 are attached to anchor 2602 such that when advanced into place in the foam plug 2600, the barbs 2604 dig into the foam plug”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haasl by Melanson, i.e. by using the barbed tip of Melanson on the end of the electrode tail of Haasl, for the predictable purpose of providing additional fixation to the system of Haasl to improve the system in the same way as Melanson
.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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