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 Arguments
The amendment to the specification dated 1/27/2026 is sufficient to overcome the previous objection. The amendment to claim 15 is sufficient to overcome the previous 112(b) rejection.
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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: a closure element in claim 1.
A closure element is interpreted to be a plug as shown in Figure 4, Element 324
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier (US Patent 5,314,451) in view of North (US Publication 2010/0331924) and Fain et al (US Patent 5,679,026).
Referring to Claims 1 and 2, Mulier teaches an electrical component for an implantable medical device, comprising: an outer shell forming a first side face and a second side face (e.g. Figures 3 and 4, Element 200/300), a functional element enclosed in the outer shell (e.g. Column 7 lines 19-20 discloses the shell contains a battery), and an arrangement of connection devices arranged on the outer shell for establishing an electrical connection of the functional element to a component of the implantable medical device outside of the outer shell (e.g. Figures 3 and 4 illustrate connectors 216-220 and 256 or 318-322 and 356). However, Mulier does not explicitly disclose wherein a first of the connection devices is arranged on the first side face and a second of the connection devices is arranged on the second side face, wherein the electrical component is configurable to assume different configuration states, wherein in a first configuration state the first of the connection devices is configured to establish said electrical connection and the second of the connection devices is deactivated, and in a second configuration state the first of the connection devices is deactivated and the second of the connection devices is configured to establish said electrical connection; and wherein the connection devices are formed by through-openings; and a closure element configured to be inserted in a connection device and form a fluid tight seal so as to facilitate retaining fluid within the outer shell. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have one face with a connector for a tripolar in-line connection and another for multiple separate connection, since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. In addition, this would improve versatility of the separate power supply and reduce costs by having a single unit that could work for both types of stimulator configurations. This would result in a first of the connection devices is arranged on the first side face and a second of the connection devices is arranged on the second side face, wherein the electrical component is configurable to assume different configuration states.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have the separate power unit 200/300 have female connectors (through-openings) and the IMD having male connector, since it has been held that rearranging parts of a prior art structure involves only routing skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). North teaches that it is known to use stops or plugs inserted into openings of unused ends as set forth in Paragraph [0032] to thereby deactivate the unused connections (e.g. tripolar in-line connection or the multiple separate connections) to provide improve versatility of the separate power supply and reduce costs by having a single unit that could work for both types of stimulator configurations. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mulier with using stops or plugs inserted into openings of unused ends to thereby deactivate the unused connections (e.g. tripolar in-line connection or the multiple separate connections) as taught by North, since such a modification would provide the predictable results of improved versatility of the separate power supply and to reduce costs by having a single unit that could work for both types of stimulator configurations.
Fain et al teaches that it is known to use biocompatible plug(s) inserted into unused lead connector port(s) as set forth in Column 6 lines 19-20 to provide improved long term device operation, when having unused ports, to reduce the risk of intrusion of bodily fluids, bacteria and other contaminants. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mulier, with a closure element configured to be inserted in a connection device and form a fluid tight seal so as to facilitate retaining fluid within the outer shell as taught by Fain et al, since such a modification would provide the predictable results of improved long term device operation, when having unused ports, to reduce the risk of intrusion of bodily fluids, bacteria and other contaminants.
Referring to Claim 3, Mulier in view of North and Fain et al teaches the electrical component according to claim 1, wherein the closure element is configured for deactivating, depending on the configuration state, the first or the second of the connection devices (e.g. Figures 3 and 4; the modified Mulier discloses based on the stimulator configuration using the proper connection and is modified by Fain et al so the unused port(s) are deactivated by the closure element (biocompatible plug)).
Referring to Claim 4, Mulier in view of North and Fain et al teaches the electrical component according to claim 1, wherein, for establishing said electrical connection, a connection line is passed through the first or the second of the connection devices, depending on the configuration state (e.g. Figures 3 and 4; the modified Mulier discloses based on the stimulator configuration using the proper connection to establish an electrical connection between the power unit 200/300 and the IMD).
Referring to Claim 6, Mulier in view of North and Fain et al teaches the electrical component according to claim 4, wherein the functional element, at a connection location inside the outer shell, is connected to the connection line, wherein the connection location is arranged symmetrically with respect to the first side face and the second side face (e.g. Figures 3 and 4 and Column 7 lines 19-20).
Referring to Claim 7, Mulier in view of North and Fain et al teaches the electrical component according to claim 1, wherein the first side face and the second side face are formed and arranged such that the first side face and the second side face are symmetric with respect to each other relative to a plane of symmetry (e.g. Figures 3 and 4).
Referring to Claim 8, Mulier in view of North and Fain et al teaches the electrical component according to claim 7, wherein the first of the connection devices and the second of the connection devices are symmetric with respect to each other relative to the plane of symmetry (e.g. Figures 3 and 4).
Referring to Claim 9, Mulier in view of North and Fain et al teaches the electrical component according to claim 7, wherein the outer shell forms a planar abutment face for placing the electrical component on another, second electrical component, wherein the plane of symmetry is perpendicular to the abutment face (e.g. Figures 3 and 4).
Referring to Claim 10, Mulier in view of North and Fain et al teaches the electrical component according to claim 1, wherein the first side face and the second side face each have a planar shape (e.g. Figures 3 and 4).
Referring to Claim 11, Mulier in view of North and Fain et al teaches the electrical component according to claim 1, wherein the first side face and the second side face are arranged at an angle with respect to each other (e.g. Figures 3 and 4).
Referring to Claim 12, Mulier in view of North and Fain et al teaches an implantable medical device, comprising at least one electrical component according to claim 1 (e.g. Figures 3 and 4, Element 300/400).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier (US Patent 5,314,451) in view of North (US Publication 2010/0331924) and Fain et al (US Patent 5,679,026) as applied to claim 4 above, and further in view of Spillman (US Publication 2002/0155350).
Referring to Claim 5, Mulier in view of North and Fain et al teaches the electrical component according to claim 4, except further comprising a guide element for guiding the connection line through the first or the second of the connection devices, depending on the configuration state.
Spillman teaches that it is known to use a guide element for guiding the connection line through the first or the second of the connection devices, depending on the configuration state as set forth in Figure 3B, Element 70 and Paragraphs [0043]-[0044] to provide a hermetic seal to reduce the potential for shorting of the device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mulier, with a guide element for guiding the connection line through the first or the second of the connection devices, depending on the configuration state as taught by Spillman, since such a modification would provide the predictable results of a hermetic seal to reduce the potential for shorting of the device.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulier (US Patent 5,314,451) in view of North (US Publication 2010/0331924) and Fain et al (US Patent 5,679,026) as applied to claim 12 above, and further in view of Elghazzawi et al (US Publication 2013/0053909).
Referring to Claim 13, Mulier in view of North and Fain et al teaches the implantable medical device according to claim 12, except wherein the implantable medical device comprises an assembly of a multiplicity of electrical components with outer shells of equal shape, wherein the multiplicity of electrical components are assembled such that the outer shells of the electrical components are in abutment with one another.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to a multiplicity of electrical components with outer shells of equal shape, wherein the multiplicity of electrical components are assembled such that the outer shells of the electrical components are in abutment with one another since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. This enables generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel).
Elghazzawi et al teaches that it is known to use a multiplicity of electrical components with outer shells of equal shape assembled such that they are in abutment with one another as set forth in Figure 6A to provide enabling generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel) of the assembly to support the medical device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mulier, with an assembly of a multiplicity of electrical components with outer shells of equal shape, wherein the multiplicity of electrical components are assembled such that the outer shells of the electrical components are in abutment with one another as taught by Elghazzawi et al, since such a modification would provide the predictable results of enabling generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel) of the assembly to support the medical device.
Referring to Claim 14, Mulier in view of North and Fain et al teaches the implantable medical device according to claim 12, except wherein the first side face of a first of the electrical components and the second side face of a second of the electrical components are aligned to extend along a common plane .
Elghazzawi et al teaches that it is known to use a multiplicity of electrical components wherein the first side face of a first of the electrical components and the second side face of a second of the electrical components are aligned to extend along a common plane as set forth in Figure 6A to provide enabling generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel) of the assembly to support the medical device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mulier, with an assembly of a multiplicity of electrical components with outer shells of equal shape, wherein a multiplicity of electrical components wherein the first side face of a first of the electrical components and the second side face of a second of the electrical components are aligned to extend along a common plane as taught by Elghazzawi et al, since such a modification would provide the predictable results of enabling generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel) of the assembly to support the medical device.
Referring to Claim 15, Mulier in view of North, Fain et al and Elghazzawi et al teaches the implantable medical device according to claim 13, wherein said assembly forms an energy storage device of the implantable medical device (e.g. Column 7 lines 19-20 and as modified by Elghazzawi et al to enable generation of a proper voltage (e.g. series) or increasing the capacity (e.g. parallel) of the assembly to support the medical device).
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796