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 .
Reopening Prosecution
In view of the Appeal Brief filed on 02/25/2026, PROSECUTION IS HEREBY REOPENED. New grounds of 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:
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Improper Claim Status Identifiers
Claims 41-43 are shown as currently “previously presented,” however, claims 41-43 were cancelled by Applicant in the filing of 04/14/2025. These claims cancellations were noted in the non-final rejection reopening prosecution filed 07/02/2025.
In order to make the record clear claims 41-43 are canceled.
Response to Arguments
Regarding Applicant’s remarks with respect to the 112 rejections, after further consideration and consultation the examiner has withdrawn these rejections. However, the examiner will be interpreting “directly coupled” as meaning ONLY “directly connected to” or “directly mounted to.”
Of Applicant’s three alleged errors only the arguments for error #1 are persuasive. Accordingly, the examiner provides multiple new grounds of rejection for the pending claims below.
However, the arguments for alleged errors #2 and #3 are unpersuasive. First, the claimed “conductively coupled” is so broad that it is met by thermal conduction/convection/radiation (thermal influences of relatively close elements – mere heat exchange) and electrically conductive (the flow of current and provision of voltage differences and electrical power), Secondly, Applicant’s unpersuasive analogous art traversal heavily weakened since both pieces of art are implantable medical devices.
Applicant is invited to request an interview to discuss suggestions to find an acceptable conclusion of the prosecution for all parties.
Due to the new grounds of rejection comprising:
1) newly cited prior art in the form of rejections based on the Keller et al. (U.S. Patent Application Publication 2020/0155860) prior art, and 2) a new and different interpretation of the previously used prior art of Mitchell et al. (U.S. Patent Application Publication 20220015708) as a primary prior art reference in obviousness rejections,
THIS ACTION IS MADE NON-FINAL.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 28-37, and 39-43 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keller et al. (U.S. Patent Application Publication 2020/0155860).
Regarding claim 17, Keller et al. disclose implantable medical device comprising:
a battery ( “energy source 107 can be a battery,” see [0040] and figures 1A-1B, 2) );
a housing enclosing the battery (comprising: 1) extensions the include: “housing 102 can contain an energy source 107 to provide power to the pacing electrodes,” see [0040] and figures 1A-1B, and 2) “fixation element 114,” see [0041] and figures 1A, and 10-11);
a printed circuit board (“flexible circuit assembly 120,” see [0043]-[0045], [0070] and figures and 7, and alternate/equivalent counterparts in other embodiments, e.g., “stacked configuration 702”) including a first surface facing a first side of the IMD and a second surface facing a second side of the IMD (see annotated reproduced figures 7 and 10 below), wherein the second side is positioned opposite the first side (see annotated reproduced figure 10 below), wherein multiple electronic components (see at least “electronic components 310” in [0052] and “electronic components” 420, 424, 602, and 604” in [0069]) are directly coupled to the first surface (see figures 3-7, and 10-17 for example), wherein the battery is conductively coupled to the second surface (see for example “battery connectors 410 can receive battery pins of the energy source 107 to transmit power from the battery to the flexible circuit assembly 120” in [0069], also see [0103]);
a non-conductive enclosure (comprising: 1) “end insulator 122,” see [0044], 2) “wall insulator 124,” 3) “ flange 1004,” and 4) “helix mount 112,” see [0044]-[0050], [0077]-[0079], and [0085] and figures 1A-16) arranged over the printed circuit board and sealing the printed circuit board, the non-conductive enclosure comprising an outer surface (see figures 1A-16); and
a first electrode (comprising: 1) “distal electrode 104,” 2) “electrode tip 1106,” see [0040], [0083] and figures 1A-1B, and 10-11) and a second electrode (“proximal electrode 106,” see [0040] and figures 1A-1B, and 10-11) both arranged on the outer surface of the non-conductive enclosure and both positioned on the first side of the IMD (the distal side).
Regarding claim 28, Keller et al. disclose the claimed invention including the housing comprises a conductive material (since the material of the housing is a physical material that has a non-zero and finite specific heat and it is therefore thermally conductive) and fully encloses (“fully encloses” is not used in the original written description and is therefore interpreted with th4 broadest reasonable interpretation) the battery (“The housing 102 can contain an energy source 107 to provide power to the pacing electrodes. The energy source 107 can be a battery, such as a lithium carbon monofluoride (CFx) cell, or a hybrid battery, such as a combined CFx and silver vanadium oxide (SVO/CFx) mixed-chemistry cell,” see [0040]).
Regarding claim 29, Keller et al. disclose the claimed invention including the non-conductive enclosure is directly coupled to the housing (since the non-conductive enclosure is immediately adjacent the battery which is contained in the housing).
Regarding claim 30, Keller et al. disclose the claimed invention including the circuit board is directly coupled to the housing (since the circuit board is contained within an area/volume immediately adjacent the housing).
Regarding claim 31, Keller et al. disclose the claimed invention including the housing extends an entire length of the IMD from a proximal end of the IMD to a distal end of the IMD (see figures 1 and 10-11).
Regarding claim 32, Keller et al. disclose the claimed invention including a full length of the battery extends a length of the housing (see “housing 102 can contain an energy source 107 to provide power to the pacing electrodes,” see [0040] and figures 1A-1B).
Regarding claim 33, Keller et al. disclose the claimed invention including the housing and the printed circuit board extend longitudinally, wherein the housing has a greater longitudinal length than the printed circuit board (see figures 1A-1B and 10-16).
Regarding claim 34, Keller et al. disclose the claimed invention including the non-conductive enclosure has a greater longitudinal length than the printed circuit board (see figures 1A-1B and 10-16).
Regarding claim 35, Keller et al. disclose the claimed invention including the housing is conductive (since the material of the housing is a physical material that has a non-zero and finite specific heat and it is therefore thermally conductive).
Regarding claim 36, Keller et al. disclose the claimed invention including the housing forms an outer surface of the IMD (since at least 114 forms an exterior surface of the IMD).
Regarding claim 37, Keller et al. disclose the claimed invention including a seal
comprising an atomic layer deposit, wherein the seal hermetically seals the IMD (see [0079]).
Regarding claims 39-42, Keller et al. disclose the claimed invention including the multiple electrical components comprise control circuitry (see abstract) and capacitors (see [0043]), the capacitors are DC blocking capacitors (that is the nature of capacitors), and the control circuitry comprises an application specific integrated circuit (the application or procedure/method of the Keller et al. prior art).
Regarding claim 43, Keller et al. disclose the claimed invention including multiple electrical components further comprise an accelerometer (an accelerometer is a device/sensor that measures/senses acceleration, see sensor 602 that measures acceleration in [0069]).
[AltContent: textbox (The first side of the circuit board is the outer side in the folded configuration and shown as the top side in figures 5 and 6 in the flat or straight configuration).)]
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[AltContent: textbox (The second side of the circuit board is the inner side in the folded configuration and shown as the top side in figures 3 and 4 in the flat or straight configuration).)][AltContent: arrow]
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[AltContent: textbox (This is the second side of the IMD - the proximal side.)][AltContent: textbox (This is the first side of the IMD - the distal side.)]
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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.
Claims 17, and 27-38 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (U.S. Patent Application Publication 20220015708) in view of case law (Rearrangement of Parts).
Regarding claim 17, Mitchell et al. disclose a device comprising:
a battery ("battery component 408 includes a rechargeable or a non-rechargeable
battery configured to provide power to the electronic components," see [0068] and
figures 4B, and 4D);
a housing enclosing the battery (the upper top half of "outer housing 402 that defines or encloses a reservoir component 404, an electronics component 406, a battery component 408, and a coil component 410. The housing 402 can therefore retain the various elements the device 400 together," see [0065] and figures 4A-4B);
a printed circuit board ("printed circuit board 420," see [0076] and figures 4B, and 4D) including a first surface (in figure 4B the first side is the bottom surface of the device 400) facing a first side of the IMD and a second surface (in figure 4B the second side is the top surface of the printed circuit board 420 having elements 418a, 418b, and 422 directly mounted thereon as shown in figure 4B) facing a second side of the IMD, wherein the second side is positioned opposite the first side,
wherein multiple electrical components (elements 418a, 418b, and 422 directly mounted thereon as shown in figure 4B, also see [0076]) are - apparently as illustrated by figure 4B - directly coupled to the second surface { although claim 17 recites "couple" it is further limited as "directly coupled to" which the examiner interprets as including 1) "directly connected/mounted to" or 2) coupled in a manner wherein nothing else has an intervening position }([0076] discloses "the electronics component 406 can include a plurality of individual elements mounted to one or both sides of a printed circuit board 420. These include a wireless communication module 422 (e.g., a Bluetooth Low Energy chip or similar module configured to enable shortrange or long-range wireless communication between the device 400 and one or more remote computing devices), a wireless charging module 424 (e.g., a wireless power receiver chip), and a plurality of sensing elements 418a-d (collectively "sensing elements 418")," see [0076] and figure 4B while noting figure 4B shows elements directly connected/mounted on the second side),
wherein the battery is conductively coupled to the second surface since the battery is electrically connected to the electronic/electrical elements connected to the second side
a non-conductive (“polymer (e.g., PEEK, silicone),” see [0065]) enclosure (the bottom half of "outer housing 402 that defines or encloses a reservoir component 404, an electronics component 406, a battery component 408, and a coil component 410. The housing 402 can therefore retain the various elements the device 400 together," see [0065] and figures 4C-4D) arranged over the printed circuit board and sealing the printed circuit board, the non-conductive enclosure comprising an outer surface; and
a first electrode (first electrode 418d, see [0076] and figure 4C, and 4D) and a second electrode (second electrode 418d, see [0076] and figure 4C, and 4D) both arranged on the outer surface of the non-conductive enclosure and both positioned on the first side of the IMD.
So apparently Mitchell et al. fail to explicitly recite that the multiple electronic components are directly coupled to the first surface of the printed circuit board that faces the first side of the device and what is missing is a teaching for placing the multiple electrical components (elements 418a, 418b, and 422, see [0076] and figures 4B and 4D) on the opposite surface of the printed circuit board 420 as shown in figure 4B, and there is such a teaching.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the placement of the multiple electrical components 418a, 418b, and 422 (shown in [0076] and figure 4B) from one surface (2nd surface) of the printed circuit board 420 to the other or opposite surf ace (1st surface) of the printed circuit board 420, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
This modification is additionally supported since Mitchell et al. disclose "the electronics component 406 can include a plurality of individual elements mounted to one or both sides of a printed circuit board 420" which tends to reduce the criticality of which particular surface of the printed circuit board the elements are mounted on all things being equal.
Regarding claim 27, Mitchell et al. disclose the claimed invention including the recited
antenna (see [0069], and [0073] for example).
Regarding claim 28, Mitchell et al. disclose the housing comprises a conductive material (thermally conductive and/or electrically conductive, see [0065]) and fully encloses the battery (see figures 4B, and 4D).
Regarding claim 29, Mitchell et al. disclose the non-conductive enclosure is directly coupled to the housing (see figures 4A-4D).
Regarding claim 30, Mitchell et al. disclose the printed circuit board is coupled to the housing (see figures 4A-4D).
Regarding claim 31, Mitchell et al. disclose the housing extends an entire length of the IMD from a proximal end of the IMD to a distal end of the IMD (see figures 4A-4D).
Regarding claim 32, Mitchell et al. disclose a full length of the battery extends a length of the housing (see figures 4A-4D).
Regarding claim 33, Mitchell et al. disclose the housing and the printed circuit board extend longitudinally, wherein the housing has a greater longitudinal length than the printed circuit board (see figures 4A-4D).
Regarding claim 34, Mitchell et al. disclose the non-conductive enclosure has a greater longitudinal length than the printed circuit board (see figures 4A-4D).
Regarding claim 35, Mitchell et al. disclose the housing is conductive (thermally conductive and/or electrically conductive, see [0065]).
Regarding claim 36, Mitchell et al. disclose the housing forms an outer surface of the IMD (see figures 4A-4D).
Regarding claim 37, (FIRST INTERPRETATION~ the atomic layer deposit is
essentially inherent or the recitation is a method of manufacture) Mitchell et al. disclose
the claimed invention including a seal that hermetically seals (see [0065]). Additionally, the recitation of the seal comprises an atomic layer deposit is met since the encasement is formed entirely of deposits of atoms of material(s) in one or more layers (more likely more layers). Finally, if Applicant is attempting to recite a method of manufacture, then Applicant must do so properly and the claimed finally product must be recite a difference achieved by the claimed method of manufacture.
Regarding claim 38, Mitchell et al. disclose a charging coil (“coil,” see [0045] and [0065]) electrically coupled to the battery for wireless charging the battery.
Claims 37, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (U.S. Patent Application Publication 20220015708) as applied to claim 17 above, and further in view of Souriau et al. (U.S. Patent Application Publication 2013/0296658). (SECOND INTERPRETATION~ the atomic layer deposit is a structural recitation)
Regarding claims 37, and 45, Mitchell et al. show the invention above,
but fail to explicitly recite:
1) the seal comprises an atomic layer deposit, and
2) the non-conductive enclosure comprises an epoxy.
Like Mitchell et al., Souriau et al. disclose an implantable medical device being biocompatible (see [0001]) and having a cover 114 (see figure lA) that is securely attached to support 102 so as to form a hermetic cavity 116 in which active element 106 is encapsulated and teach:
The component may include several active elements which are encapsulated hermetically and individually in cavities formed between the cover, or the covers, and several supports which are electrically insulated from one another, where each of the active elements is electrically connected to one of the electrically conductive supports and to the cover, or to one of the covers.
See [0038]
The support and the cover may be coated in a biocompatible material, for example silicon, parylene, an epoxy resin, silicon oxide, tantalum oxide and/or titanium oxide, produced for example in the form of a thin layer produced by atomic deposition (ALD).
See [0039].
These teachings of 1) the seal (sealed non-conductive enclosure or hermetical encapsulation) being accomplished by atomic layer deposition, and 2) the non-conductive enclosure (hermetical encapsulation) comprising an epoxy is undertaken in order to provide a known and workable manner of providing biocompatible, insulative (electrically non-conductive) hermetic seal for an implantable device.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Mitchell et al., as taught by Souriau et al., to provide 1) a hermetic seal made via atomic layer deposition and/or 2) non-conductive enclosure comprising an epoxy in order to provide a known and workable manner of providing biocompatible and insulative hermetic seal for an implantable device.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (U.S. Patent Application Publication 20220015708) as applied to claim 17 above, and further in view of Meadows et al. (U.S. Patent 6,516,227).
Regarding claim 39, Mitchell et al. disclose the claimed invention including the
multiple electrical components comprise control circuitry ("controller," see [0072]) and
capacitive coupling (see [0073]).
However, Mitchell et al. fail to explicitly recite capacitors.
Like Mitchell et al., Meadows et al. disclose an implantable device having (a) an hermetically sealed case, (b) electronically circuitry, ( c) coupling capacitors, ( d) header connector, (e) electrode array, (f) rechargeable battery, etc. (see col. 4:22-56) and teach the multiple electrical components comprise capacitors ("Net de charge transfer is prevented during stimulation through the use of coupling capacitors Cl, C2, C3, ... C16 (see FIGS. 4A or 4C) between the electrodes El, E2, E3, ... E16 and the IPG output" (Meadows, col 13, ln 48-51) in order to provide a known and workable capacitive coupling for an implantable device.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Mitchell et al., as taught by Meadows et al., to provide capacitors in a known and workable manner in order to provide capacitive coupling for a medically implantable device.
Regarding claim 40, Mitchell et al. in view of Meadows et al. disclose ( or make
obvious) claimed invention including the capacitors are DC-blocking capacitors. Capacitors in general have the property of blocking or impeding DC signals/currents of direct current - a capacitor is a DC-blocking capacitor.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (U.S. Patent Application Publication 20220015708) as applied to claim 17 above, and further in view of Askarinya et al. (U.S. Patent Application Publication 2012/0303105).
Regarding claim 44, Mitchell et al. disclose the claimed invention including the
multiple electrical components comprise control circuitry ("controller," see [0072]) and
capacitive coupling (see [0073]).
However, Mitchell et al. fail to disclose the non-conductive enclosure comprises a liquid crystal polymer.
Like Mitchell et al., Askarinya et al. disclose an implantable device having an electrode, circuitry, and an enclosure and teach making the enclosure from a liquid crystal polymer in order to provide a biocompatible as well as a hermetic seal around the circuitry (see abstract, [0002], [0023], [0042], and [0044] for example).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Mitchell et al., as taught by Askarinya et al., to use a non-conductive enclosure made of a liquid crystal polymer in order to provide a biocompatible as well as a hermetic seal around the circuitry of the implantable device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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