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 of Prosecution
In view of the Appeal Brief filed on 05/27/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejections 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
Response to Arguments
Applicant's arguments filed 05/27/2025 (the arguments contained in the Appeal Brief) have been fully considered but they are not persuasive. The examiner will rebut each of the alleged errors, #1 through #7 contained in pages 4-8 of the Appeal Brief filed 05/27/2025.
Regarding alleged Error #1 (beginning of page 4 and ending on page 5), these arguments are not entirely relevant since the grounds of rejections have been changed. It should be noted the Mitchell et al. prior art has been modified by case law motivating the modification of essentially switching the placement of multiple electrical components 418a, 418b, and 422 from the one surface of the printed circuit board to the opposite/other surface of the printed circuit board by using the rearrangement of parts case law which is supported by Mitchell et al. since Mitchell et al. disclose placement of the multiple electrical components (“electronics component 406,” [0076]) on “ one or both sides of a printed circuit board 420,” see [0076].
Regarding alleged Error #2 (beginning of page 5 and ending on page 6), these arguments are no longer relevant since the grounds of rejection have been changed and “conductively coupled” is no longer interpreted as directly connected/attached to.
Regarding alleged Error #3 (beginning of page 6), these arguments are no longer relevant since the grounds since the housing is now interpreted as being met by element 402 of the Mitchell et al. prior art and as illustrated in figures 4A-4D element 402 of Mitchell et al. “extends an entire length of the IMD from a proximal end of the IMD to a distal end of the IMD.”
Regarding alleged Error #4 (beginning of page 6), these arguments are no longer relevant since the grounds since the housing is now interpreted as being met by element 402 of the Mitchell et al. prior art and as illustrated in figures 4A-4D element 402 of Mitchell et al. “forms an outer surface of the IMD.”
Regarding alleged Error #5 (beginning of page 6 and ending on page 7), Applicant asserts:
“the cited passage of Souriau ([0039]) does not teach or suggest that its "thin layer produced by atomic deposition" is capable of or creates a hermetic seal. Instead, paragraph [0068] of Souriau requires use of a "sealing bead 118 comprising an electrically conductive material, for example gold, or a gold-based biocompatible alloy" to provide a hermetic seal. Neither Mitchell, nor Souriau, nor their combination teach or suggest a hermetic seal comprising an atomic layer deposit. As such, the proposed combination fails to teach or suggest the features of claim 37.”
This argument is unpersuasive since Mitchell et al. do teach providing a hermetic seal while Souriau et al. teach sealing with an atomic layer deposition. Applicant’s argument appears to be attacking the prior art references individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts.
Regarding alleged Error #6 (beginning of page 7), Applicant’s argument is unpersuasive since element 409 of the Mitchell et al. prior art and the hermetic seal made from ALD are analogous and used to hermetically seal electrical elements/components. The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts.
Regarding alleged Error #7 (beginning of page 7 and ending on page 8 with respect to the rejections of claims 39 and 40), firstly, both prior art references discuss capacitive coupling for implantable medical devices. The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts. Here Meadows et al. teaches accomplishing the capacitive coupling through the use of capacitors. Secondly and thirdly, and again, both prior art references discuss capacitive coupling for implantable medical devices. The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art, and all teachings in the prior art must be considered to the extent that they are in analogous arts. Here Meadows et al. teaches accomplishing the capacitive coupling through the use of capacitors.
Applicant is invited to request an interview to discuss suggestions to find an acceptable conclusion of the prosecution for all parties. The examiner made two calls to Applicant and left a voicemail message both times.
Due to the new grounds for rejection, this action is made non-final.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the recited “the printed circuit board is directly coupled to the housing” of claim 30 (lines 1-2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
112(1st)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 27-40, and 44-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 (lines 6-7) recites “multiple electrical components are directly coupled to the first surface.” The written description contains no support for such a recitation.
In order to provide an examination and search the examiner will interpret said recitation to be equivalent to “multiple electrical components are coupled to the first surface.”
Claim 29 (lines 1-2) recites “the non-conductive enclosure is directly coupled to the housing.” The written description contains no support for such a recitation.
In order to provide an examination and search the examiner will interpret said recitation to be equivalent to “the non-conductive enclosure is coupled to the housing.”
Claim 30 (lines 1-2) recites “the printed circuit board is directly coupled to the housing.” The written description contains no support for such a recitation.
In order to provide an examination and search the examiner will interpret said recitation to be equivalent to “the printed circuit board is directly coupled to the housing.”
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.
Claim(s) 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 (“an 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-4D);
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 short-range 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 {here “conductively coupled” is interpreted broadly to include: 1) thermally conductively coupled, as well as 2) electrically conductively coupled. IT SHOULD BE NOTED “CONDUCTIVELY COUPLED” IS INTERPRETED MUCH BROADER THAN “DIRECTLY COUPLED.”} (the battery of “battery component 408” is thermally conductively coupled to the second side since both the battery and the second surface are made of physical materials having finite and non-zero specific heats and would therefore thermally influence each other through thermal convection at the very least, the battery of “battery component 408” is electrically conductively coupled to the second surface since the electronics/electrical components of 406 that are mounted on the second side are electrically powered and influenced by the electrical power supplied by the battery);
a non-conductive enclosure (“encasement 409” made of plastic, silicone, or ceramic (all of which are insulators, i.e., electrically non-conductive), see [0070] and figure 4A-4D) arranged over the printed circuit board and sealing the printed circuit board (“hermetic seal,” see [0070]), the non-conductive enclosure comprising an outer surface (the outer surface of 409 in figures 4A-4D); and
a first electrode (a first electrode 418d and the intervening electrical connections to the printed circuit board, see [0076] and figure 4C, and 4D) and a second electrode (a second electrode 418d and the intervening electrical connections to the printed circuit board that is different from the first 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 surface (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 claimed invention including a 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 claimed invention including the non-conductive enclosure is directly coupled or coupled to the housing (see the top side of figure 4B wherein nothing or no element is intervening between 402 and 409).
Regarding claim 30, Mitchell et al. disclose the claimed invention including the printed circuit board is coupled to the housing (since the printed circuit board 420 is enclosed by the housing 402 and they are part of the same device see figures 4B, and 4D).
Regarding claims 31-34, Mitchell et al. disclose the claimed invention see figures 4A-4D for example.
Regarding claims 35-36, Mitchell et al. disclose the claimed invention (the housing 402 forms an outer surface of the device and is comprised of materials that are conductive, thermally and/or electrically, see [0065] 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 (the encasement 409 also forms a hermetic seal, see [0070]). 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 the claimed invention see [0045].
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 1A) 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 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In spite of the newly made 112(a) rejections to claims 17, 29, and 30 and although the claims do not recite the battery is 1) directly connected to the printed circuit board, or 2) directly attached, fixed, or secured to the printed circuit board, or 3) directly mounted on the printed circuit board it should be noted it is well known in the art to directly connect a battery to a printed circuit board as Stein et al. (U.S. Patent Application Publication 2013/0079669) disclose in [0085] and figure 7. Currently, claim 17 recites that the battery is conductively coupled to the second surface of the printed circuit board wherein conductively coupled can be properly interpreted as:, 1) thermally conductive, 2) electrically conductive, or 3) both.
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-7pm.
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
Prosecution Insights