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 .
Claim Objections
Claim 2 is objected to because of the following informalities: a typographical error of “in that” appears in line 4. Based on the other amendments, it appears that this phrase should be deleted. 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: 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 § 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 having a housing comprising
a processor (¶[0094] microprocessor based system including a control system),
a memory unit (¶¶[0094-0095] memory circuit),
a single electrode connection port (Fig. 1, female coupler 192),
a stimulation unit configured to provide an electrode being connected to the electrode connection port with an electric pulse to stimulate a human or animal heart (¶¶[0050-0051] pulse generator), and
a detection unit (¶[0116]) configured to receive an electric signal of the same heart (¶[0117]) from the same electrode (¶¶[0118-0119] reconfigured between monitoring and stimulation), wherein the electrode connection port is configured to receive a transvenously implantable electrode or a substernally 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 if a transvenously implantable electrode is connected to the electrode connection port and in a second operational mode if a substernally implantable electrode is connected to the electrode connection port (¶[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
an electrode connected to the electrode connection port of the implantable cardioverter-defibrillator (Figs. 1-2).
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 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 electrode is transvenously implanted or substernally implanted (¶¶[0211-0212]); and
c) operating the implantable cardioverter-defibrillator in the first operational mode if the electrode is transvenously implanted and in the second operational mode if the 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 electrode in order to determining whether the connected electrode is a transvenously implanted electrode or a 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 electrode in the first operational mode differs from a second connection configuration between the connector poles and the 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2017/0281962 to Kroll teaches a multi-model electrotherapy apparatus.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792