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
In view of the Appeal Brief filed on 8/3/2026, PROSECUTION IS HEREBY REOPENED. New grounds for rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792
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.
Claim(s) 1-5, 11-16, 18, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tischendorf et al. (U.S. Patent Application Publication No. 2016/0331978) hereinafter referred to as Tischendorf; in view of O’Flynn et al. (U.S. Patent Application Publication No. 2014/0277234) hereinafter referred to as Flynn; in view of Pang et al. (U.S. Patent Application Publication No. 2009/0306594) hereinafter referred to as Pang.
Regarding claims 1 and 3, Tischendorf teaches an implantable medical device (Fig. 11, IMD 500) comprising:
a housing (Fig. 11, element 501 comprising two shot injection mold elements 502 support member and 504 overmold member, ¶[0093]) comprising a polymeric material (¶[0093]), wherein the housing further comprises a first portion and a second portion mechanically fastened, adhered, bonded, or welded to the first portion (Fig. 11, element 501 comprising two shot injection mold elements 502 support member and 504 overmold member, ¶[0093]);
an electronics module disposed within the housing (Fig. 12, element 522) and comprising a substrate (Fig. 12, element 520, ¶[0094]), a power source (Fig. 12, secondary coil element 526), and circuitry disposed on the substrate and electrically connected to the power source (¶[0095]); and
a conformal coating disposed over at least a portion of the electronics module (¶[0094] “coated with a highly conformable coating such as paralene, epoxy, or liquid silicone rubber”).
Tischendorf further teaches that the power source can comprise one or more rechargeable battery cells
Tischendorf does not teach a power source disposed on the substrate, or wherein the power source is disposed on a first major surface of the substrate and the circuitry is disposed on a second major surface of the substrate.
Attention is drawn to the Flynn reference, which teaches a power source disposed on the substrate (Fig. 3, power source 304 on PCB substrate 200), wherein the power source is disposed on a first major surface of the substrate (Fig. 3, power source 304 on PCB substrate 200) and the circuitry is disposed on a second major surface of the substrate (Fig. 3, elements 302).
Flynn does not teach a reason, such as a teaching, suggestion, or motivation for why PHOSITA would include an internal battery in a device that uses external power.
Attention is drawn to the Pang reference, which teaches redundant power sources and a reason why PHOSITA would look to add an additional, redundant power source to an implantable medical device: for safety purposes, upon failure of a main power source, an additional power source may provide safe operation (¶[0011]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the implantable medical device of Tischendorf, to include an additional internal battery as a power source, on and connected to the circuit substrate, as taught by Flynn, to yield redundancy of power that is useful for safety purposes (Pang ¶[0011]).
Regarding claim 2, Tischendorf as modified teaches the device of claim 1.
Tischendorf further teaches wherein the conformal coating covers substantially all of the electronics module (¶[0094] “coated with a highly conformable coating such as paralene, epoxy, or liquid silicone rubber”).
Regarding claims 4-5, Tischendorf as modified teaches the device of claim 1.
Tischendorf does not teach further comprising a contact disposed within the housing and adapted to electrically connect the electronics module to a lead disposed within a lead bore of the housing that extends between a first end at an outer surface of the housing and a second end disposed within the housing, wherein the housing defines a first cavity and a second cavity, wherein the electronics module is disposed in the first cavity, wherein the contact is disposed in the second cavity, and further wherein the second end of the lead bore is connected to the second cavity.
Attention is drawn to the Flynn reference, which teaches a contact disposed within the housing and adapted to electrically connect the electronics module to a lead disposed within a lead bore of the housing that extends between a first end at an outer surface of the housing and a second end disposed within the housing (¶[0021] connector block element 130, Fig. 5), wherein the housing defines a first cavity and a second cavity, wherein the electronics module is disposed in the first cavity, wherein the contact is disposed in the second cavity, and further wherein the second end of the lead bore is connected to the second cavity (Fig. 5, cavities defined by dotted lines indicating boundaries of 130 and 200).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the IMD lead connector of Tischendorf to include a bore, as taught by Flynn, to take advantage of existing standards for implantable leads (¶[0020]) improving safety and cost.
Regarding claims 11-13, and 15-16, the claims are directed to a system comprising substantially the same subject matter as claims 1-5, and rejected under substantially the same sections of Tischendorf, Flynn, and Pang.
Regarding claim 14, Tischendorf teaches the system of claim 11.
Tischendorf does not teach wherein the implantable medical device is an implantable defibrillator, however Tischendorf teaches a minimally invasive IMD for automated therapy (¶[0046]) which is considered to encompass applications of electrical energy therapy throughout the body.
Flynn further teaches an implantable defibrillator (¶[0019], ¶[0027]).
It would have been obvious to implement the improvements of Tischendorf as modified in an implantable defibrillator, because Tischendorf states that its improvements are applicable to the overall field of implantable devices and are applicable to any type of IMD to enhance therapies, saving cost, conserving energy, and minimizing patient/clinician burden (¶[0046]).
Regarding claims 18 and 20, the claims are directed to a method comprising substantially the same subject matter as claims 1-2, and rejected under substantially the same sections of Tischendorf, Flynn, and Pang.
Regarding claim 22, Tischendorf as modified teaches the device of claim 1.
Tischendorf teaches further comprising at least one vent or gate, wherein at least one of medical adhesive or epoxy is backfilled through the vent or gate and into the housing (¶¶[0099-0100] injected and cured).
Claim(s) 6-7, 9-10, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tischendorf, Flynn, and Pang as applied to claims 1, 11, and 18 above, and further in view of Francis et al. (U.S. Patent Application Publication No. 2007/0250142) hereinafter referred to as Francis.
Regarding claim 6-7, and 9-10, Tischendorf as modified teaches the device of claim 1.
Tischendorf teaches a conformal coating including paralene, epoxy, or liquid silicone rubber (¶[0094]), a second portion of a conformal coating comprises a second material different from the first material (¶[0094]).
Tischendorf as modified does not teach wherein the conformal coating comprises an atomic or molecular layer deposited conformal coating, wherein the conformal coating comprises an oxide material comprising at least one of titanium oxide or aluminum oxide, wherein the conformal coating comprises alternating layers of an oxide material and a parylene material, wherein the conformal coating comprises a first portion disposed over the power source and a second portion disposed over the circuitry, wherein the first portion of the conformal coating comprises a first material and the second portion of the conformal coating comprises a second material different from the first material.
Attention is brought to the Francis reference, which teaches a conformal coating comprising an atomic or molecular layer deposited conformal coating (¶[0004]), wherein the conformal coating comprises an oxide material comprising at least one of titanium oxide or aluminum oxide (¶¶[0017-0018]), wherein the conformal coating comprises alternating layers of an oxide material and a parylene material (Francis, ¶[0018], and the parylene is taught by Tischendorf, above), wherein the conformal coating comprises a first portion disposed over the power source and a second portion disposed over the circuitry, wherein the first portion of the conformal coating comprises a first material (¶¶[0017-0018], notably, the Pang reference teaches that a battery, specifically, is typically coated with metal for safety reasons in ¶[0125] of Pang).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the IMD conformal coating of Tischendorf to use atomic layer deposition, and oxide materials as taught by Francis, because Francis teaches increased miniaturization and reduced failure (Francis ¶[0003]).
Regarding claims 17 and 19, the claims are directed to a system comprising substantially the same subject matter as claims 6-7 and 9-10 and are rejected under substantially the same sections of Tischendorf, Flynn, Pang, and Francis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2019/0117981 to Bilu et al. teaches parylene as a vapor deposition product.
U.S. Patent Application Publication No. 2021/0346705 to Jiang teaches a two-part case/housing for a pacing device, including defibrillation, a hermetic feedthrough for an internal battery, a two-part polymeric case for the battery, among other features.
U.S. Patent Application Publication No. 2017/0246459 to Kelley et al. teaches two conformal layers of polymer and metallized polymer and a benefit of detecting leakage of body fluid.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights