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 Amendment
The amendment filed August 3, 2026 has been entered. Claims 1-3, 6-10, 14-15 have been amended. Currently, claims 1-15 are pending for examination.
Response to Arguments
Applicant's arguments filed August 3, 2026 have been fully considered but they are not persuasive under a different interpretation of the prior art. Applicant argues Zellmer et al. (US 2021/0128919) does not expressly disclose “an implant comprising a first and second component being linked to one another by a first and second connecting element having a film-like shape with a specified thickness” (p.7). Applicant’s broad recitation of first component and second component and the first connecting element and the second connecting element “adheres at least section-wise” to the first component as well as to the second component allows for an alternative interpretation of Zellmer et al. to reject claim 1.
Claim Rejections - 35 USC § 112
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 15 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 15, line 3 recites, “a connecting element” but lines 6-7 have been amended to recite “each of the first connecting element and the second connecting element”. Given the amendments to claim 1 and 15, it is unclear if applicant intends there to be a separate and distinct additional “a connecting element” or if the applicant intends for it to be the first connecting element and the second connecting element.
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.
(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.
Claim(s) 1-2, 10-15 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Zellmer et al. (US 2021/0128919).
Regarding claim 1, Zellmer et al. discloses an active implantable medical device comprising a housing 100 and a first component and a second component (“electronic components 130 connected to, or directly on the circuitry system, comprising a set of electrodes 132 and an antenna 134; and wiring 150, connecting the circuitry system and electronic components” [0057]) received within the housing (fig. 1), wherein the first component and the second component are stabilized and mechanically linked to each other by a first connecting element (“the circuitry system 105 includes a casing circuitry subsystem (e.g., a printed circuit board (PCB)) contained within the casing 140” [0059]) and a second connecting element 105, 110 (“the circuitry surface 110 may include a printed circuit board (PCB), wherein electronic components 130 are based on or connected to the PCB” [0071]) to form a composite unit (fig. 2), wherein each of the first connecting element and the second connecting element has a film-like shape with a thickness lying in a range of from 0.01 mm to 0.1 mm (“The PCB typically has a flat sheet-like geometry… the thickness of the PCB sheet is (C)=˜0.1 mm” [0075]) and adheres at least section-wise to the first component as well as to the second component (“the casing circuitry subsystem may include exposed electrical connectors or couplers that operatively connect to one or more circuitry surfaces no within the implant body 100” [0059]; “The casing-embedded circuitry system can be connected to a circuitry surface 110 through wiring 150, i.e. a wired conductive connection.” [0065]; “electronic components may be directly connected to the circuitry system 105, or may be connected to the circuitry system 105 through wiring 150” [0093]; “adheres at least section-wise” is broadly interpreted to read on the electrical connectors/couplers between casing 140 and implant body 100, or the wiring throughout 140 and 100 connecting the electronic components to the PCBs).
Regarding claim 2, Zellmer et al. discloses each of the first connecting element and the second connecting element is configured to exert a tensioning force onto the first component and the second component upon exertion of a deforming force onto the composite unit ([0086-0090]).
Regarding claim 10, Zellmer et al. discloses each of the first connecting element and the second connecting element (“PCB”) exhibits an electric functionality and is electrically connected to at least one of the first component and the second component ([0059], [0071]).
Regarding claim 11, Zellmer et al. discloses the first component and the second component touch each other at at least one contact point (fig. 11, 20; “sheathing 120” [0089], [0095]).
Regarding claim 12, Zellmer et al. discloses the first component and the second component touch each other via at least one supporting element arranged at least partially between the first component and the second component (fig. 11, 20-21; “sheathing 120” [0089]).
Regarding claim 13, Zellmer et al. discloses wherein the supporting element is an electric insulator (“the sheathing 120 may electronically insulate components” [0089]).
Regarding claim 14, Zellmer et al. discloses wherein each of the first connecting element and the second connecting element additionally adheres to the housing ([0084], [0156]).
Regarding claim 15, Zellmer et al. discloses a method for manufacturing an active implantable medical device according to claim 1, wherein the method comprises the following step: adhering a connecting element 105, 110 at least section-wise to a first component and to a second component 130 of an active implantable medical device 100 (“the casing circuitry subsystem may include exposed electrical connectors or couplers that operatively connect to one or more circuitry surfaces no within the implant body 100” [0059]; “The casing-embedded circuitry system can be connected to a circuitry surface 110 through wiring 150, i.e. a wired conductive connection.” [0065]; “electronic components may be directly connected to the circuitry system 105, or may be connected to the circuitry system 105 through wiring 150” [0093]; “adheres at least section-wise” is broadly interpreted to read on the electrical connectors/couplers between casing 140 and implant body 100, or the wiring throughout 140 and 100 connecting the electronic components to the PCBs) to stabilize and mechanically link the first component and the second component to each other and to form a composite unit (“a circuitry system 105, containing at least one electronic component; electronic components 130 connected to, or directly on the circuitry system” [0057]; “the circuitry system 105 includes a casing circuitry subsystem (e.g., a printed circuit board (PCB)) contained within the casing 140” [0059]; “the circuitry surface 110 may include a printed circuit board (PCB), wherein electronic components 130 are based on or connected to the PCB” [0071]), wherein each of the first connecting element (“the circuitry system 105 includes a casing circuitry subsystem (e.g., a printed circuit board (PCB)) contained within the casing 140” [0059]) and the second connecting element (“the circuitry surface 110 may include a printed circuit board (PCB), wherein electronic components 130 are based on or connected to the PCB” [0071]) has a film-like shape with a thickness lying in a range of from 0.01 mm to 0.1 mm (“The PCB typically has a flat sheet-like geometry… the thickness of the PCB sheet is (C)=˜0.1 mm” [0075]).
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.
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.
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US 2021/0128919).
Regarding claim 5, Zellmer et al. discloses the composite unit (“PCB”) is flexible and bendable ([0074]) but does not expressly disclose it bends under dead load by not more than 20°. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select a composite unit such that it bends under dead load by not more than 20°, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Zellmer et al. discloses the composite unit (“PCB”) comprises tensile strength ([0086-0090]) but does not expressly disclose wherein each of the first connecting element and the second connecting element is tensile proof and allows an elastic deformation of not more than 5% per 1 N. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select a composite unit to be tensile proof and allows an elastic deformation of not more than 5% per 1 N, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 3, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US 2021/0128919) in view of Loo et al. (US 2020/0171212).
Regarding claim 3, Zellmer et al. does not expressly disclose each of the first connecting element and the second connecting element comprises at least one aperture but does disclose wiring 150 of several components to the connecting element 110 ([0065], [0071], [0093], [0098], [0100], [0115]). Loo et al. teaches an implantable medical device comprising a connecting element (“PCB antenna”) that connects to an electronics package of an implantable device by wire leads inserted through apertures (“vias”) in the connecting element ([0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first connecting element and the second connecting element of Zellmer et al. to comprise apertures as taught by Loo et al. in order to enable wiring of the components to the connecting element since it is a known technique in the art, the results of such a modification being reasonably predictable.
Regarding claim 7, Zellmer et al. does not expressly disclose each of the first connecting element and the second connecting element adheres to the first component and the second component by at least one of gluing, a hook-and-loop fastening, a vacuum cup connection, friction, brazing, welding, a magnetic connection, and a snap-action connection. Loo et al. teaches it is known in the art to adhere a connecting element (“PCB”) to other components (“electronics package”) via welding ([0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connecting element of Zellmer et al. to adhere to the first component and the second component by welding as taught by Loo et al. since it is a known technique in the art, the results of such a modification being reasonably predictable.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US 2021/0128919) in view of Bailey et al. (US 2022/0087604).
Regarding claim 4, Zellmer et al. discloses the active implantable medical device comprises a plurality of connecting elements 105, 110 (fig. 2) but does not expressly disclose that the plurality of connecting elements are arranged in an at least partially crossing pattern. Bailey et al. teaches it is known in the art in implantable medical devices to present connecting elements (“PCBs”) in an at least partially crossing pattern (“trifold printed circuit assembly”) in order to overlap and save physical space ([0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zellmer et al. to arrange the plurality of connecting elements such that they are in an at least partially crossing pattern as taught by Bailey et al. in order to save physical space within the implantable medical device ([0111]) and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US 2021/0128919) in view of Hannan (US 2022/0357507).
Regarding claim 7, Zellmer et al. does not expressly disclose each of the first connectin element and the second connecting element adheres to the first component and the second component by at least one of gluing, a hook-and-loop fastening, a vacuum cup connection, friction, brazing, welding, a magnetic connection, and a snap-action connection. Hannan teaches it is known in the art to adhere components 13, 33 to a connecting element 11 via gluing ([0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connecting element of Zellmer et al. to adhere to the first component and the second component by gluing as taught by Hannan since it is a known technique in the art, the results of such a modification being reasonably predictable.
Regarding claim 8, Zellmer et al. in view of Hannan teach each of the first connecting element and the second connecting element adheres to the first component and the second component by gluing, wherein the gluing is realized by at least one of self-gluing layer of the connecting element, a hot glue, and an adhesive polymer (“non-conductive adhesive” or “conductive glue” [0041]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US 2021/0128919) in view of Buchner et al. (US 2023/0284391).
Regarding claim 9, Zellmer et al. does not expressly disclose wherein each of the first connecting element and the second connecting element comprises reinforcing fibers. Buchner et al. teaches it is known in the art for printed circuit boards to comprise a base substrate that consist of fiber-reinforced plastic of polymeric films or laminated paper ([0003]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to consider the first connecting element and the second connecting element (“PCB” [0059], [0071]) of Zellmer et al. to comprise reinforcing fibers given Buchner et al. discloses they are well known components in base substrates that make up printed circuit boards.
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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