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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2026 has been entered.
Response to Arguments
Applicant's amendments and arguments filed 8/11/2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102, Applicant alleges that the Lovett reference does not teach “the housing has an electrode connector consisting of exactly one electrode connection port configured to receive only one electrode…the exactly one electrode being a single transvenously implantable electrode or a single substernally implantable electrode.”
Firstly, Lovett teaches a housing has an electrode connector consisting of exactly one electrode connection port:
Fig. 1-2, element 192 female connection port in housing element 103. As depicted in the figures, there is exactly one female connection port and no more.
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Further, Lovett teaches “electrode connection port configured to receive only one electrode” by the following disclosure:
¶[0083]: In FIG. 1, the reconfigurable cardiac device 182 detects and records cardiac activity when operating in a monitoring-only configuration. A housing or can 103 is illustrated that incorporates a header 100. The header 100 facilitates removable attachment between an electrode module 196 and the can 103. The header 100 includes a female coupler 192 configured to accept a male coupler 193 from the electrode module 196. The male coupler 193 is shown having two electrode contacts 194, 195 for coupling one or more electrodes 197 through the electrode module 196 to the can 103.
Element 197 referrs to one or more electrodes, which clearly provides for a single electrode. One or more is an inclusive range, and the minimum of the range is 1. Therefore, the electrode port is configured to receive only one electrode because Lovett discloses a function of connecting only one electrode (one or more) and because even if Lovett did not teach specifically connecting only one electrode by this disclosure, Lovett would nevertheless teach that the electrode connection port element 192 is capable of receiving only one electrode. As Applicant has claimed that the electrode connection port is “configured to receive” only one electrode, this function is an intended use of the electrode connection port. Therefore, the electrode connection port of Lovett must only be capable of performing the claimed function in order to meet the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Notably, while the electrode connector consists of only one electrode connection port, there is no such restriction on the electrode itself. The claim as a whole remains constructed as “open” because the claim as a whole uses the transitional phrase “comprising.” Only the electrode connector appears to be restricted by use of the transitional phrase “consisting.”
Lastly, Lovett is considered to teach “the exactly one electrode being a single transvenously implantable electrode or a single substernally implantable electrode.”In further disclosure, ¶[0128]:
FIGS. 5-8 illustrate embodiments of the present invention after reconfiguring the reconfigurable cardiac device from a monitoring/recording configuration to a configuration that provides for delivery of cardiac therapies. Referring now to FIG. 5, there is shown a reconfigurable cardiac device, in a therapy configuration, implanted in the chest region of a patient in accordance with an embodiment of the present invention. A typical cardiac device in accordance with a cardiac monitoring and stimulation implementation of present invention may include one or more subcutaneous electrodes and/or one or more transvenous, epicardial, and/or endocardial electrodes.
Therefore Lovett discloses one or more subcutaneous electrode, and/or one or more transvenous, …electrodes. Furthermore, it is noted that Lovett specifically discloses unipolar configuration in ¶[0015] and ¶[0110] therefore confirming that Lovett is capable of use with exactly one attached electrode.
Applicant’s arguments appear to be solely directed to whether Lovett teaches “the housing has an electrode connector consisting of exactly one electrode connection port configured to receive only one electrode…the exactly one electrode being a single transvenously implantable electrode or a single substernally implantable electrode.” As these arguments are considered to be sufficiently addressed, the rejection is maintained.
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: stimulation unit, and detection unit in claim 1-2, 4, 7, and 14.
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.
The disclosure appears to teach that the stimulation and detection units are a set of parameters and algorithms on an ICD for each of these units, therefore the stimulation unit and detection unit are interpreted as algorithms on an ICD, that are programmable.
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 1-14 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 limitation of “exactly one” substernally implanted electrode is not provided for in the specification as filed. Further, due to an apparent difference in terminology, it’s not clear that “exactly one” transvenously implanted electrode is provided for in the specification as filed. From pp. 12-13 of the Specification as filed (emphasis added):
Fig. 1A shows an implantable cardioverter-defibrillator (ICD) 1 having a housing 2 and an electrode connection port 3. A transvenously implanted electrode 4 is connected to the electrode connection port 3. The transvenously implanted electrode 4 is implanted into a human heart 5 via the superior vena cava. The electrode 4 comprises a shock coil 6, a ring electrode pole 7 and a tip electrode pole 8.
By measuring an impedance between the ring electrode 7 or the tip electrode 8 on the one hand and the housing 2 and the other hand, the ICD 1 determines whether the electrode 4 is indeed a transvenously implanted electrode. If the impedance would be too low, a substernally implanted electrode was rather be connected to the electrode connection port 3. Such a situation is illustrated in Fig. 1B. In this and all following Figures, similar elements will be denoted with the same numeral references.
In Fig. 1B, a substernally implanted electrode 14 is connected to the connection port 3 of the housing 2 of the ICD 1 already shown in Fig. 1A. The substernally implanted electrode 14 is located diagonally above the human heart 5. It also comprises a shock coil 6, a ring electrode 7 and a tip electrode 8. While the ring electrode 7 is located between the shock coil 6 and the tip electrode 8 in case of the transvenously implanted electrode 4 (cf. Fig. lA), the ring electrode 7 is located proximally of the shock coil 6 in case of the substernally implanted electrode 14. However, other electrode pole arrangements would also be possible.
Each of these arrangements describe the connected lead as a single electrode, however, subsequently describe the single electrode as comprising a plurality of electrodes including ring electrode 7 and tip electrode 8. The accompanying figures also appear to disclose single leads which comprise two electrodes. Therefore, the originally filed disclosure does not appear to support Applicant’s amendments to “exactly one” electrode as argued herein.
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 1-14 are 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.
Regarding claims 1, 6-7, 11, and 13-14, there is insufficient antecedent basis for “the exactly one electrode.” Claim 1 recites the limitation "the exactly one electrode" in line 11. There is insufficient antecedent basis for this limitation in the claim as line 8 claims “only one electrode”. Therefore, the antecedence is not provided for “exactly one” electrode. Claims 6-7, 11, and 13-14 further recite “the exactly one electrode”. For the purposes of examination, “the exactly one electrode” will be interpreted as “the only one electrode”.
Regarding claims 1-14, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “electrode” in claims 1-14 is used by the claim to mean “lead,” while the accepted meaning is “electrode.” The term is indefinite because the specification does not clearly redefine the term. Applicant’s specification appears to use the term “pole” or “electrode pole” where prior art uses the term “electrode” and Applicant appears to use the term “electrode” where prior art uses the term “lead”. Applicant’s cooperation with clarifying the terminology in the Specification and claims is respectfully requested.
Claim Rejections - 35 USC § 102
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) 1-3, 6-11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lovett et al. (U.S. Patent Application Publication No. 2004/0215240) hereinafter referred to as Lovett.
Regarding claim 1, Lovett teaches implantable cardioverter-defibrillator comprising
a processor (¶[0094] microprocessor based system including a control system),
a memory unit (¶¶[0094-0095] memory circuit),
a stimulation unit (¶¶[0050-0051] pulse generator), and
a detection unit (¶¶[0116-0117]),
and a housing (Fig. 1-2, element 103 CAN/housing) wherein
the housing has an electrode connector consisting of exactly one electrode connection port (Fig. 1-2, female coupler 192) for only one electrode (¶[0083] “one or more electrodes” which encompasses one single electrode, ¶[0128] one or more subcutaneous electrodes and/or one or more transvenous, epicardial, and/or endocardial electrodes, furthermore, configured for receiving only one electrode is an intended use and the port of Lovett is clearly capable of said use as “one or more” includes the capability of just one) that when connected to the electrode connector will receive an electric pulse from the stimulation unit to stimulate a human or animal heart and will generate an electric signal of the same heart to be received by the detection unit (¶[0120] sensing and shocking, further may be operated in unipolar mode ¶[0110] and includes configurations with one electrode ¶[0058], ¶[0128], and ¶¶[0118-0119] reconfigured between monitoring and stimulation),
the exactly one electrode being a single transvenously implantable electrode (¶[0154]) or a single substernally (¶[0156])implantable electrode (¶[0058], ¶[0128], Figs. 5-8),
wherein the memory unit comprises a computer-readable program that causes the processor to operate the stimulation unit and/or the detection unit in a first operational mode when the exactly one electrode is a single transvenously implantable electrode in a second operational mode when the exactly one electrode is the single substernally implantable electrode (¶[0155-0159], Figs. 9-11).
Regarding claim 2, Lovett teaches implantable cardioverter-defibrillator according to claim 1.
Lovett further teaches wherein the first operational mode comprises a first set of parameters and algorithms for generating an electric pulse by the stimulation unit and for sensing an electric signal by the detection unit and the second operational mode comprises a second set of parameters and algorithms for generating an electric pulse by the stimulation unit and for sensing an electric signal by the detection unit (Figs. 4 and 12, ¶¶[0160-0162]), the second set differing from the first set (¶[0161]).
Regarding claim 3, Lovett teaches implantable cardioverter-defibrillator according to claim 2.
Lovett further teaches wherein the first set of parameters and algorithms and the second set of parameters and algorithms comprise a shock energy of the electric pulse to be generated by the stimulation unit (Figs. 4 and 12, shock therapy circuitry).
Regarding claim 6, Lovett teaches defibrillation arrangement comprising
an implantable cardioverter-defibrillator according to claim 1 (see rejection, above, of claim 1) and
the exactly one electrode connected to the electrode connection port of the implantable cardioverter-defibrillator (Figs. 1-2, ¶[0083] “one or more electrodes” which encompasses one single electrode).
Regarding claim 7, Lovett teaches defibrillation arrangement according to claim 6.
Lovett further teaches wherein the memory unit comprises a computer-readable program that causes the processor to perform the following steps when executed on the processor:
a) measuring, with the detection unit and the exactly one electrode, at least one physiologic parameter of a patient to whom the defibrillation arrangement is implanted (¶[0211]);
b) determining, based on the at least one physiologic parameter, whether the connected exactly electrode is transvenously implanted or substernally implanted (¶¶[0211-0212], ¶[0154], ¶[0156]); and
c) operating the implantable cardioverter-defibrillator in the first operational mode if the single electrode is transvenously implanted and in the second operational mode if the single electrode is substernally implanted (¶¶[0156-0159], ¶[0171]).
Regarding claim 8, Lovett teaches defibrillation arrangement according to claim 7.
Lovett further teaches wherein the at least one physiologic parameter is chosen from the group consisting of an impedance (¶[0173]) and an electrocardiogram (¶[0201]).
Regarding claim 9, Lovett teaches defibrillation arrangement according to claim 7.
Lovett further teaches wherein the at least one physiologic parameter is an electrocardiogram and in that the determining comprises an analysis of a temporal occurrence of signals detected in the electrocardiogram (¶[0201] cardiac cycle length in the time domain is a temporal length).
Regarding claim 10, Lovett teaches defibrillation arrangement according to claim 7.
Lovett further teaches wherein the at least one physiologic parameter is an electrocardiogram and in that the determining comprises a morphologic analysis of signals detected in the electrocardiogram (¶[0201] morphology of the ECG).
Regarding claim 11, Lovett teaches defibrillation arrangement according to claim 6.
Lovett further teaches wherein the computer-readable program causes the processor to read out an electronic identifier (Figs. 1-2, element 191 electrode detection circuit, ¶[0083]) of the exactly one electrode in order to determine whether the connected exactly one electrode is a single transvenously implanted electrode or a single substernally implanted electrode (¶[0083], ¶[0087], ¶[0119]).
Regarding claim 13, Lovett teaches defibrillation arrangement according to claim 6.
Lovett further teaches wherein the connection port comprises a plurality of connector poles, wherein a first connection configuration between the connector poles and electrode poles of the connected exactly one electrode in the first operational mode differs from a second connection configuration between the connector poles and the exactly one electrode poles in the second operational mode (¶[0101], Figs. 9-11).
Regarding claim 14, the claim is directed to a method comprising substantially the same subject matter as claim 7 and is rejected under substantially the same sections of Lovett.
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.
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.
Claim(s) 4-5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lovett as applied to claim 1 above, and further in view of Min (U.S. Patent Application Publication No. 2020/0324132) hereinafter referred to as Min.
Regarding claims 4-5, Lovett teaches Implantable cardioverter-defibrillator according to claim 1.
Lovett further teaches a first operational mode setting safety parameters preventing the stimulation unit from generating a number of shocks exceeding a maximum (¶[0205]).
Lovett does not teach wherein the first operational mode comprises a safety arrangement preventing the stimulation unit from generating an electric pulse having a voltage and/or an energy exceeding a predeterminable threshold, the threshold is chosen from 60 J and 1000 V.
Attention is drawn to the Min reference, which teaches a first operational mode comprises a safety arrangement preventing a stimulation unit from generating an electric pulse having a voltage and/or an energy exceeding a predeterminable threshold and the threshold is chosen from 60 J and 1000 V (¶¶[0033-0034] medium voltage shock, limited by threshold compared to high voltage shock).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the operational modes of Lovett to include a predetermined voltage and energy threshold, as taught by Min, because the different shock modes produce an effective defibrillation therapy at a significantly reduced energy level to enable a significant size reduction in the implantable medical devices (Min, ¶[0005]).
Regarding claim 12, Lovett teaches defibrillation arrangement according to claim 6.
Lovett is silent as to the voltage of the electric pulse.
Attention is drawn to the Min reference, which teaches a defibrillation arrangement configured to deliver an electric pulse having a voltage of at least 60 V between an electrode pole and a pole of an implantable cardioverter-defibrillator both in a first operational mode and in a second operational mode (¶¶[0033-0034], ¶[0047], medium and high voltage shocks both are over 60V).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the operational modes of Lovett to include defibrillation arrangement voltage of at least 60V, as taught by Min, because the different shock modes nevertheless produce an effective defibrillation therapy at a significantly reduced energy level to enable a significant size reduction in the implantable medical devices (Min, ¶[0005]).
Conclusion
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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