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 .
Drawings
The drawings are objected to because in Figure 5 . 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 Objections
Claim 13 is objected to because of the following informalities:
In claim 13, line 1, “wherein coil and antenna” should read “wherein the coil and the antenna”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“interface system” in claim 1, equivalent structure found in para. 0058. Therefore, in light of the specification, a “interface system” is best understood as a coil and antenna configured to receive power signals and wireless electrical signals, respectively, and equivalents thereof. Claim 9 is noted as reciting structure for performing the claimed function; therefore, an “interface system” is not subject to this interpretation.
“treatment system” in claims 2 and 15; equivalent structure is not recited in the specification.
“communication system” in claims 2, 15, and 17; equivalent structure found in para. 0070. Therefore, in light of the specification, a “communication system” is best understood as hardware or circuitry, such as wireless personal area network technology, wherein the hardware/circuit is configured to generate, transmit, and receive electrical communication signals, and equivalents thereof.
“recharge system” in claim 2, 15, and 17; equivalent structure found in para. 0070. Therefore, in light of the specification, a “recharge system” is best understood as hardware or circuity configured to receive and provide power signals to a battery, for instance, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 2-3 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 limitation “treatment system” in claims 2 and 15 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not recite sufficient structure to perform the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 8 recites the limitation “electronic components” in line 2. It is unclear whether the “electronic components” are synonymous to the previously recited “electronic components” in claim 1, line 3, or if the “electronic components” in claim 8, line 2 are associated with a different technical feature entirely. For examination purposes, the “electronic components” recited in claims 1 and 8 are being treated as the same technical feature.
Claim 14 recites “a patient” in line 3. It is unclear whether the “patient” recited in claim 14, line 3 is synonymous to the “patient” recited in claim 1, line 8, or if the “patient” recited in claim 1 is different from the “patient” recited in claim 14. For examination purposes, the patient recited in claims 1 and 14 is regarded as the same entity.
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.
Claim(s) 1-3, 9, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Severson (US 2017/0231738).
Regarding claim 1, Severson teaches an implantable medical device (Abstract; paras. 0029 and 0038-0039; Fig. 3, electronic control system 302), comprising:
a housing forming an internal compartment (paras. 0030 and 0039);
electronic components disposed within the internal compartment (paras. 0030-0031, 0038-0039, and 0054-0056; Fig. 8);
an interface system (Fig. 3, wireless charging pad 308) configured to receive at least one of power signals and wireless electrical communication signals (para. 0038); and
an elongated tether having a conductive lead (Fig. 3, connector 310; paras. 0029 and 0039, wherein the connector comprises tubing and electrical conductors), wherein the tether mechanically couples the housing to the interface system (paras. 0029 and 0039, wherein the connector’s tubing is being construed as the structure that performs the mechanical coupling) and allows the housing and interface system to be implanted at spaced-apart locations within a patient (para. 0038, wherein the wireless charging pad 308 may disposed just under the skin of the person’s thigh, stomach, lower back, side or any other body part; see Fig. 3, wherein because of the connector 310, the electronic control system 302 and wireless charging pad 308 may be located in separate locations; see Annotated Figure 3), further wherein the conductive lead electrically couples the interface system to the electronic components (para. 0039, “a wireless charging pad 308 is connected to the electronic control system 302 via a conductor 310”).
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Annotated Figure 3
Regarding claim 2, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Severson teaches the implantable medical device according to claim 1 as stated above wherein the electronic components include a treatment system (Fig. 8, actuator controller 810 and EAP controller 810; paras. 0031 and 0055-0056), a communication system (paras. 0031 and 0054; Fig. 8, network interface 808), and a recharge system (Fig. 8, battery-charging/capacitor charging controller 812), and the recharge system is coupled to a rechargeable power source (paras. 0030, 0038, 0043, and 0054-0056; para. 0030, wherein the electronic control system, which includes the battery-charging/capacitor charging controller 812, has electronic interconnects that connect to internal and external components, such as the rechargeable battery; Fig. 8, rechargeable battery 818).
Regarding claim 3, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Severson teaches the implantable medical device according to claim 2 as stated above wherein the rechargeable power source is a battery disposed within the internal compartment (paras. 0006, 0030, 0038, and 0043; Fig. 8).
Regarding claim 9, Severson teaches the implantable medical device according to claim 1 as stated above wherein the interface system includes a coil configured to receive the power signals and an antenna configured to receive the wireless electrical communication signals (para. 0038).
Regarding claim 14, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Severson teaches the implantable medical device according to claim 1 as stated above wherein the housing (para. 0039, “housing of the electronic control system 302”) is configured to be implanted in a first location of a patient (see Annotated Figure 3 above; paras. 0029 and 0038) and the interface system (Fig. 3, wireless charging pad 308) is configured to be implanted in a second location (paras. 0006, 0008-0009, and 0038, wherein the wireless charging pad is configured to be disposed just beneath a person’s skin, the wireless charging pad’s location just beneath the skin is being construed as the “second location”; see Annotated Figure 3 above) of the patient.
Regarding claim 15, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Severson teaches a method to implant an implantable medical device within a patient (paras. 0028-0029), the method comprising:
providing an implantable medical device (paras. 0029 and 0038-0039; Fig. 3, electronic control system 302), the implantable medical device including:
a housing forming an internal compartment (paras. 0030 and 0039);
electronic components (para. 0031; Fig. 8) and a rechargeable power source (Fig. 8, rechargeable battery 818) disposed within the internal compartment (0006, 0030-0031 and 0038-0039, and 0043; Fig. 8), the electronic components including a treatment system (Fig. 8, actuator controller 810 and EAP controller 810; paras. 0031 and 0055-0056), a communication system (paras. 0031 and 0054; Fig. 8, network interface 808) and a recharge system (Fig. 8, battery-charging/capacitor charging controller 812), the recharge system coupled to the rechargeable power source (paras. 0030, 0038, 0043, and 0054-0056; para. 0030, wherein the electronic control system, which includes the battery-charging/capacitor charging controller 812, has electronic interconnects that connect to internal and external components, such as the rechargeable battery; Fig. 8, rechargeable battery 818);
an interface system (Fig. 3, wireless charging pad 308) including at least one of a coil configured to receive power signals and an antenna configured to receive wireless electrical communication signals (para. 0038); and
an elongated tether having a conductive lead (Fig. 3, connector 310; paras. 0029 and 0039, wherein the connector comprises tubing and electrical conductors), wherein the tether mechanically couples the housing to the interface system (paras. 0029 and 0039, wherein the connector’s tubing is being construed as the structure that performs the mechanical coupling) and allows the housing and interface system to be implanted at spaced-apart locations within a patient (para. 0038, wherein the wireless charging pad 308 may disposed just under the skin of the person’s thigh, stomach, lower back, side or any other body part; see Fig. 3, wherein because of the connector 310, the electronic control system 302 and wireless charging pad 308 may be located in separate locations; see Annotated Figure 3), further wherein the conductive lead electrically couples the at least one of the coil and the antenna to the electronic components (para. 0038; para. 0039, “a wireless charging pad 308 is connected to the electronic control system 302 via a conductor 310”);
implanting the housing in a first location within the patient (see Annotated Figure 3; paras. 0028-0029 and 0038); and
implanting the interface system at a second location with the patient and spaced-apart from the first location (paras. 0006, 0008-0009, and 0038, wherein the wireless charging pad is configured to be disposed just beneath a person’s skin, the wireless charging pad’s location just beneath the skin is being construed as the “second location”; see Annotated Figure 3).
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Annotated Figure 3
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) 4-5, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson.
Regarding claim 4, Severson, in the embodiment relied upon above, teaches the implantable medical device according to claim 1 as stated above. Severson, in the embodiment relied upon above, fails to teach a fluidic circuit disposed within the internal compartment.
Severson, in a separate embodiment, teaches a fluidic circuit disposed within the internal compartment (Fig. 2A, pump 208A; paras. 0032-0034).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the implantable medical device disclosed in the first embodiment of Severson with the fluidic circuit disclosed in the second embodiment of Severson. The pump effectively moves fluid in and out of the actuator, allowing it to change shape and treat conditions like erectile dysfunction (Severson, para. 0028).
Regarding claim 5, a modified Severson teaches the implantable medical device according to claim 4 as stated above wherein the fluidic circuit includes a pump assembly in fluid communications with a valve assembly and a pressure sensor (Severson, para. 0032-0034).
Regarding claim 17, Severson teaches an implantable urological device (paras. 0028; Claim 4) comprising:
an inflatable member (Fig. 3, actuator 304; para. 0028, 0038);
an implantable medical instrument (Fig. 3, electronic control system 304) in fluid communication with the inflatable member (paras. 0038; para. 0029, wherein the connector, that connects the electronic control system and actuator comprises tubing for carrying a fluid), the implantable medical instrument comprising:
a housing forming an internal compartment (paras. 0030 and 0039);
the electronic components coupled to a rechargeable power source (paras. 0030, 0038, 0043, and 0054-0056; para. 0030, wherein the electronic control system has electronic interconnects that connect to internal and external components, such as the rechargeable battery; Fig. 8, rechargeable battery 818), the electronics components disposed within the internal compartment (paras. 0030-0031, 0038-0039, and 0054-0056; Fig. 8);
wherein the electronic components include a communication system (paras. 0031 and 0054; Fig. 8, network interface 808) and a recharge system (Fig. 8, battery-charging/capacitor charging controller 812) disposed within the internal compartment (Fig. 8), the recharge system coupled to the rechargeable power source (paras. 0030, 0038, 0043, and 0054-0056; para. 0030, wherein the electronic control system, which includes the battery-charging/capacitor charging controller 812, has electronic interconnects that connect to internal and external components, such as the rechargeable battery; Fig. 8, rechargeable battery 818);
an interface system (Fig. 3, wireless charging pad 308) including at least one of a coil and an antenna, the coil configured to receive power signals, and the antenna configured to receive electrical communication signals (para. 0038); and
an elongated tether having a conductive lead (Fig. 3, connector 310; paras. 0029 and 0039, wherein the connector comprises tubing and electrical conductors), wherein the tether mechanically couples the housing to the interface system (paras. 0029 and 0039, wherein the connector’s tubing is being construed as the structure that performs the mechanical coupling) and allows the housing and interface system to be implanted at spaced-apart locations withing the patient (para. 0038, wherein the wireless charging pad 308 may disposed just under the skin of the person’s thigh, stomach, lower back, side or any other body part; see Fig. 3, wherein because of the connector 310, the electronic control system 302 and wireless charging pad 308 may be located in separate locations; see Annotated Figure 3), further wherein the conductive lead electrically couples the at least one of the coil and the antenna to the electronic components (para. 0038; para. 0039, “a wireless charging pad 308 is connected to the electronic control system 302 via a conductor 310”).
Severson, in the embodiment relied upon above, fails to specifically teach a reservoir configured to receive a fluid; an inflatable member in fluid communication with the reservoir; an implantable medical instrument in fluid communication with the reservoir; the implantable medical instrument comprising: a fluidic circuit disposed within the internal compartment, the fluidic circuit including a pump assembly configured to transfer the fluid from the reservoir to the inflatable member; and electronic components operably coupled to the fluidic circuit and configured to operate the fluidic circuit.
Severson, in a separate embodiment, teaches a reservoir configured to receive a fluid (Fig. 2A, reservoir 210A); an inflatable member in fluid communication with the reservoir (para. 0032; Fig. 2A, actuator 204A and reservoir 210A); an implantable medical instrument (Fig. 2A, electronic control system 202A) in fluid communication with the reservoir (paras. 0032-0033); the implantable medical instrument comprising: a fluidic circuit disposed within the internal compartment (paras. 0032-0034), the fluidic circuit including a pump assembly (Fig. 2A, pump 208A) configured to transfer the fluid from the reservoir to the inflatable member (paras. 0004, 0028, and 0032-0033); and electronic components operably coupled to the fluidic circuit and configured to operate the fluidic circuit (paras. 0005, 0028, and 0032-0034).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the implantable urological device disclosed in the first embodiment of Severson with the reservoir and fluidic circuit disclosed in the second embodiment of Severson. The pump effectively transfers fluid between the actuator and the fluid reservoir, which supplies fluid to the actuator and collects the expelled fluid from the actuator. This configuration allows the actuator to change shape, thereby enabling functions such as inflating/deflating to promote male erections, and/or permitting/restricting to control urine flow through the urethra (Severson, para. 0028).
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Annotated Figure 3
Regarding claim 19, a modified Severson teaches the implantable urological device according to claim 17 as stated above wherein the inflatable member includes an inflatable cuff configured to be disposed about a urethra (Severson, paras. 0004-0005 and 0028; Claim 3).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Gramse et al. (US 2008/0109044).
Regarding claim 6, a modified Severson teaches the implantable medical device according to claim 4 as stated above. While a modified Severson teaches the fluidic circuit (Fig. 2A, pump 208A; paras. 0032-0034) and the electronic components (Fig. 3, electronic control system 302), a modified Severson fails to teach wherein the internal compartment includes a plurality of partitions including a first partition and a second partition, the fluidic circuit disposed within the first partition and the electronics components disposed in the second partition, wherein the first partition is hermetically sealed from the second partition.
In the same field of endeavor, Gramse et al. teaches wherein the internal compartment includes a plurality of partitions including a first partition (Fig. 1, second hermetically sealed compartment 13) and a second partition (Fig. 1, first hermetically sealed compartment 12), the battery disposed within the first partition (paras. 0016 and 0019) and the electronics components disposed in the second partition (para. 0016 and 0018), wherein the first partition is hermetically sealed from the second partition (Abstract; para. 0016).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the implantable medical device of a modified Severson with the hermetically sealed partitions of Gramse et al. The hermetically sealed partitions may electrically insulate the electronics from the other essential components of the implantable medical device (Gramse et al., paras. 0009 and 0016).
Regarding claim 7, a modified Severson in view of Gramse et al. teaches the implantable medical device according to claim 6 as stated above. A modified Severson further teaches wherein the tether (Fig. 3, connector 310) includes a proximal end and a distal end (see Annotated Figure 3A), wherein the distal end is mechanically coupled to the interface system (para. 0038), and the proximal end is mechanically coupled to the housing (para. 0039).
A modified Severson fails to teach wherein the proximal end is received within a partition of the plurality of partitions.
Gramse et al., further teaches wherein the proximal end of the tether is received within a partition of the plurality of partitions (Fig. 2; para. 0017).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the implantable medical device of a modified Severson in view of Gramse et al. with the lead connected to the partition of Gramse et al. Connecting the proximal ends of medical leads to the first hermitically sealed compartment facilitates a direct interface between the electrical circuit and the medical leads (Gramse et al., para. 0017).
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Annotated Figure 3A
Regarding claim 8, as best understood in light of the rejections under 35 U.S.C. 112(b) above, a modified Severson in view of Gramse et al. teaches the implantable medical device according to claim 6 as stated above. A modified Severson further teaches wherein the conductive lead (para. 0029, “A connection 106 connects the electronic control system 102 and actuator 104; the connection may include tubing for carrying a fluid, such as kink-resistant tubing, electrical conductors for carrying analog and/or digital electronic signals”; Fig. 3, connector 310) is electrically coupled to electronic components (para. 0031; Fig. 8; Fig. 3, electronic control system 302) via feedthrough connections coupled to the proximal end (paras. 0029-0030 and 0039; See Annotated Figure 3A above). A modified Severson fails to specifically teach feedthrough pins.
Gramse et al. further teaches feedthrough pins (para. 0017; Fig. 2, conductive pins 34).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the implantable medical device of a modified Severson in view of Gramse et al. with the feedthrough pins of Gramse et al. The feedthrough pins allow the medical leads to establish an electrical connection with the implantable component through mated interconnects (Gramse et al., para. 0017).
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Aber et al. (US 2017/0063164).
Regarding claim 10, Severson teaches the implantable medical device according to claim 9 as stated above. Severson further teaches wherein the coil and the antenna are disposed within a round, silicone structure (para. 0038). Severson fails to teach a ceramic puck.
In the same field of endeavor, Aber et al. teaches a ceramic puck (paras. 0018 and 0050; Fig. 7, wherein the implanted receiving assembly 15 is shaped as a disc/puck).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the implantable medical device of Severson with the ceramic puck of Aber et al. Doing so offers an electrically insulated and biocompatible housing for the conductors (Aber et al., paras. 0018 and 0050).
Regarding claim 13, Severson in view Aber et al. teaches the implantable medical device according to claim 10 as stated above. Severson further teaches wherein the coil and antenna are disposed within a flexible round structure formed of a polyurethane or silicone (para. 0038). Severson fails to teach a puck.
Aber et al. further teaches a puck (Fig. 7, wherein the implanted receiving assembly 15 is shaped as a disc/puck).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the implantable medical device of Severson with the puck of Aber et al. Smaller-sized devices are preferred for implant purposes because they enable efficient power transfer while reducing thickness and volume (Aber et al., paras. 0061 and 0073).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Aber et al., further in view of Andrews et al. (US 2012/0123342).
Regarding claim 11, Severson, in view of Aber et al. teaches the implantable device according to claim 10 as stated above. Aber et al. further teaches wherein the puck includes a first major surface (Fig. 10, cover 110) and an opposite second major surface (Fig. 10, biocompatible housing 90). Severson in view of Aber et al. fails to teach wherein the first major surface is coupled to a mesh layer.
In the same field of endeavor, Andrews et al. teaches a mesh layer coupled to an implantable device (Fig. 13, mesh layer 94; paras. 0042, 0070, and 0078).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the implantable medical device of Severson, in view of Aber et al., with the mesh layer of Andrews et al. The mesh layer may promote tissue growth around the implanted component (Andrews et al., para. 0049).
Regarding claim 12, Severson, in view of Aber et al., further in view of Andrews teaches the implantable medical device according to claim 11 as stated above. Aber et al. further teaches the second major surface (Fig. 10, biocompatible housing 90); however, Aber et al. and Andrews et al. fail to teach wherein the second major surface is textured to form a protrusion.
Severson further teaches a textured surface to form a protrusion (para. 0038).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the implantable medical device of Severson, in view of Aber et al., further in view of Andrews et al. with the protrusion of Severson. The molded holes or protrusions may facilitate a surgeon in anchoring the implantable device within the body to prevent migration (Severson, para. 0038).
Claim(s) 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Forsell (US 2021/0378811).
Regarding claim 16, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Severson teaches the method according to claim 15 as stated above. Severson further teaches coupling the tether to the electronic components (Fig. 3, connector body 314; para. 0039, wherein the connector body 314 contains integral electrical leads that interconnect with the connector’s leads when the connectors are engaged in the connector body’s male and/or female connector sockets). Severson fails to specifically teach wherein the tether is integrally formed with the interface system; nonetheless, it has been held that the use of an integral construction instead of the connector disclosed in Severson would be merely a matter of obvious engineering choice to create a modular component that minimizes the size of the implantable assembly. See MPEP 2144.04VB.
In the same field of endeavor, Forsell teaches integral wires (paras. 0050-0051 and 0054).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Severson with the integral connections of Forsell. The integral connector efficiently supplies electrical power and fluids to other components within the implantable system, while securely anchoring the implantable device within the body (Forsell, paras. 0049-0052).
Regarding claim 20, a modified Severson teaches the implantable urological device according to claim 17 as stated above. A modified Severson further teaches wherein the tether is removable coupleable to the medical instrument (Fig. 3, connector body 314; para. 0039, wherein the connector body 314 contains integral electrical leads that interconnect with the connector’s leads when the connectors are engaged in the connector body’s male and/or female connector sockets). A modified Severson fails to specifically teach wherein the interface system is integrally formed with the tether; nonetheless, it has been held that the use of an integral construction instead of the connector disclosed in Severson would be merely a matter of obvious engineering choice to create a modular component that minimizes the size of the implantable assembly. See MPEP 2144.04VB.
In the same field of endeavor, Forsell teaches integral wires (paras. 0050-0051 and 0054).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the implantable urological device of a modified Severson with the integral connections of Forsell. The integral connector efficiently supplies electrical power and fluids to other components within the implantable system, while securely anchoring the implantable device within the body (Forsell, paras. 0049-0052).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Severson in view of Smith et al. (US 2020/0222188).
Regarding claim 18, a modified Severson teaches the implantable urological device according to claim 17 as stated above. A modified Severson further teaches a bladder-tube actuator in fluid communication with the medical instrument and the reservoir (paras. 0004-0006 and 0028; Fig. 2A, actuator 204A, reservoir 210A, and electronic control system 202A; Claim 3).
A modified Severson fails to teach wherein the inflatable member includes a plurality of inflatable cylinders, the plurality of inflatable cylinders configured to be disposed within a corpora cavernosa of a penis.
Smith et al. teaches an analogous implantable urological device wherein the inflatable member includes a plurality of inflatable cylinders (Fig. 6, a pair of cylinders 608), the plurality of inflatable cylinders configured to be disposed within a corpora cavernosa of a penis (Claim 12; paras. 0005, 0024, 0081, and 0083).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the implantable urological device of a modified Severson with the inflatable cylinders of Smith et al. Implanting cylinders into the erectile tissue, i.e., the corpora cavernosa of the patient, and inflating them may promote an erection of the penis (Smith et al., paras. 0062 and 0083).
Conclusion
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/B.R.L./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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