DETAILED ACTION
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 .
The amendment filed on January 28, 2026 has been received and considered. By this amendment, claims 1-5, 7, 8, and 11-16 are amended, claims 18 and 19 are cancelled, claims 21 and 22 are added, and claims 1-17 and 20-22 are now pending in the application.
Claim Rejections - 35 USC § 112
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 1-17 and 20-22 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. The disclosure fails to describe the invention in the manner claimed, specifically failing to describe “a second conductive material covering at least a portion of the first major surface of the first nonconductive body to form a second electrode, the second electrode is electrically coupled to the integrated circuitry” as now required by independent claim 1. The disclosure does describe two electrodes 112 and 114, however these electrodes are formed on separate nonconductive bodies and not on the same nonconductive body, as is currently claimed. As such, the claims contain 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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the first nonconductive portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the second nonconductive portion" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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, 7-17, and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruben (U.S. 2016/0192524). Regarding claim 1, Ruben discloses an implantable medical device (IMD) 2 comprising: integrated circuitry 6; a housing 3 enclosing a battery 5, which is electrically coupled to control circuitry to provide power to the integrated circuitry (see Figure 1A and “the electronic device 6 can include any suitable integrated circuit or circuits, e.g., a controller, a multiplexer, etc. It should be understood that any of the electronic devices mentioned in this disclosure can be coupled to a power source. For instance, in one or more embodiments, the electronic device 6 can also include a power source 5 that is adapted to provide power to one or more integrated circuits or devices disposed within the housing 3”, paragraph [0054]); a first nonconductive body 12 coupled to a first end of the housing, the first nonconductive body including a first major surface and a first outer portion extending from the first major surface; a first conductive material 22/32 covering at least a portion of the first major surface of the first nonconductive body to form a first electrode, the first electrode is electrically coupled to the integrated circuitry; a second nonconductive body 12 coupled to a second end of the housing, the second nonconductive body including a second major surface and a second outer portion extending from the second major surface; a second conductive material 22/32 covering at least a portion of the first major surface of the first nonconductive body to form a second electrode, the second electrode is electrically coupled to the integrated circuitry (see annotated Figure 1A below and “the substrate 12 can be a single unitary substrate or multiple substrates joined together”, paragraph [0059]).
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Regarding claim 2, Ruben discloses that a top surface of the first conductive material 22 is flush with a top surface of the first outer portion of the first nonconductive body (see Figure 1A that shows conductive material 22 flush at the top and bottom with the substrate 12).
Regarding claim 3, Ruben discloses that at least one of the first nonconductive body and the second nonconductive body is made of ceramic, glass, or sapphire (“the substrate 12 can include at least one of glass, quartz, silica, sapphire, silicon carbide, diamond, synthetic diamond, and gallium nitride, or alloys or combinations (including clad structures, laminates etc.) thereof”, paragraph [0057]).
Regarding claim 4, Ruben discloses that at least one of the first nonconductive body and the second nonconductive body comprises a ceramic material (“the substrate 12 can include at least one of glass, quartz, silica, sapphire, silicon carbide, diamond, synthetic diamond, and gallium nitride, or alloys or combinations (including clad structures, laminates etc.) thereof”, paragraph [0057]), where it is known that silica is a ceramic material based on its processing. Silica is processed to become quartz, glass, or ceramic and because glass and quartz are both recited separately from silica in Ruben, it is respectfully submitted that Ruben anticipates a ceramic material by the recitation of silica.
Regarding claim 7, Ruben discloses that the IMD is configured to monitor cardiac activation signals, wherein the first electrode is configured to sense the cardiac activation signals (“one or more therapeutic electrodes can be electrically coupled to one or more external contacts 32 of the feedthrough assembly 10. In one or more embodiments, one or more of the external contacts 32 can be coupled to electrodes through conductors to provide electrical stimulation therapy to a patient or sense physiological signals, such as cardiac signals, from a patient”, paragraph [0135]).
Regarding claim 8, Ruben discloses that the first nonconductive body includes a well (via 20) surrounded by the first outer portion, wherein the first electrode is at least partially positioned within the well (see Figure 1A).
Regarding claim 9, Ruben discloses that the well is approximately 0.1 to 1 millimeter deep (the well is via 20 disposed through the entire thickness of substrate 12, which “has a thickness of approximately 100 to 500 μm” {paragraph [0060]}, resulting in a well being 0.1 to 0.5 millimeter deep).
Regarding claim 10, Ruben discloses an antenna electrically coupled to the integrated circuitry (“one or both of conductors 50, 52 can be formed to provide an antenna for communication”, paragraph [0082]).
Regarding claim 11, Ruben discloses a third nonconductive body coupled to the housing between the first end and the second end, wherein the antenna is surrounded by the third nonconductive body (see annotated Figure 1A above).
Regarding claim 12, Ruben discloses that the antenna is formed along a non-linear path (see Figure 1A).
Regarding claim 13, Ruben discloses that the first nonconductive body is at least partially positioned between the first electrode and the housing (see Figure 1A).
Regarding claim 14, Ruben discloses that the first major surface of the first nonconductive body includes a first conduit 20 (see Figure 1A).
Regarding claim 15, Ruben discloses that the first conduit is brazed (“In one or more embodiments, the feedthrough can be formed through the substrate using low temperature techniques that do not require the use of ferrules, glasses, or brazing materials”, paragraph [0047]).
Regarding claim 16, Ruben discloses that the housing, the first nonconductive body and the second nonconductive body form an elongated structure (see Figure 1A).
Regarding claim 17, Ruben discloses that the battery is a rechargeable battery, the IMD further comprising a charge coil electrically coupled to the battery (“The power source 5 can be rechargeable by electrically coupling the power source to a power supply through the feedthrough assembly 10. In one or more embodiments, the power source 5 can be adapted to be inductively charged by an inductive power system that is external to the package 2.”, paragraph [0054]).
Regarding claim 20, Ruben discloses that the battery and the integrated circuitry are electrically coupled to a common printed circuit board (see Figure 1A that shows battery 5 and integrated circuit 6 disposed on a common printed circuit board).
Regarding claim 21, Ruben discloses that the second major surface of the second nonconductive body includes a second conduit 20 (see Figure 1A, where conduits are shown corresponding to each electrode).
Regarding claim 22, Ruben discloses that the first electrode is at least partially surrounded by the first nonconductive portion to prevent the first electrode from coming into contact with an outer surface of the housing; and the second electrode is at least partially surrounded by the second nonconductive portion to prevent the second electrode from coming into contact with an outer surface of the housing (see annotated Figure 1A above).
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ruben (U.S. 2016/0192524, cited above). Regarding claim 5, Ruben discloses the invention substantially as claimed, including that “conductive material 22 can include any suitable conductive material or combination of conductive materials, e.g., copper, titanium, aluminum, chromium, nickel, gold, composites (e.g., silver-filled epoxies), and combinations thereof” (paragraph [0061]) and “external contact 32 can include any suitable conductive material or combination of conductive materials, e.g., copper, silver, titanium, niobium, zirconium, tantalum, stainless steel, platinum, iridium, or alloys or combinations (including clad structures, laminates etc.) thereof. In one or more embodiments, the external contact 32 can include two or more materials, e.g., bi-metals, clad structures or laminates, etc.” (paragraph [0062]). However, Ruben fails to disclose that at least one of the first nonconductive body and the second nonconductive body is titanium nitride (TiN). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive material of Ruben to be titanium nitride (TiN), as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07
Regarding claim 6, Ruben discloses the invention substantially as claimed, but fails to disclose that the integrated circuitry comprises an application specific integrated circuit (ASIC). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the IMD of Ruben such that the integrated circuitry comprises an application specific integrated circuit (ASIC) since it was known in the art that an application specific integrated circuit is used to tailor a circuit for a particular use, thereby resulting in lower power consumption and higher performance.
Response to Arguments
Applicant's arguments filed January 28, 2026 have been fully considered but they are not persuasive. Regarding the rejection of the claims as being anticipated by Ruben, the Applicant argues that Ruben fails to disclose a first nonconductive body coupled to a first end of the housing and a second nonconductive body coupled to a second end of the housing and merely discloses at paragraph [0059] that “the substrate 12 can be a single unitary substrate or multiple substrates joined together” and there would be no reason to modify the single unitary substrate or multiple substrates joined together into distinct nonconductive bodies coupled to different ends of the housing. It is respectfully submitted that there is no need to modify Ruben at all to arrive at the claimed invention because Ruben discloses multiple substrates joined together, which would satisfy the broadest reasonable interpretation for first and second nonconductive bodies. Applicant further argues that Ruben fails to disclose the first nonconductive body including a first major surface and a first outer portion extending from the first major surface and the second nonconductive body including a second major surface and a second outer portion extending from the second major surface. It is respectfully submitted that, as shown in annotated Figure 1A above, Ruben does disclose these elements. For at least the reasons given above, the rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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