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 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:
Claims 5, 10, 15 and 21, “filter mode switch system,” regarding which 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.
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 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, 4, 5, 9, 10, 14, 15 and 20-21, and Claims 2-3, 6-7, 11-12, and 16-17 by dependency 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.
Regarding Independent Claim 1, Claim 1 recites “a mode adaptive coefficient filter system for real time electrocardiogram ("ECG") waveform processing of ECG waveforms received from a plurality of ECG electrodes, the mode adaptive coefficient filter system including at least one active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter.” The Present Specification provides no information regarding what the “mode adaptive coefficient filter system” actually is. That is to say, while the Present Specification describes how the “mode adaptive coefficient filter system” functions, it does not explain in what sense the “mode adaptive coefficient filter system” is a system. Instead, it appears that the “mode adaptive coefficient filter system” is a result achieved by software rather than a physical “system.” Para. [0038] of the Present Specification is most pertinent, and explains “[t]he mode adaptive coefficient filter system 300 may be implemented in software, hardware, or a combination thereof,” but states of such hardware only that it “may” be “an integrated circuit device of some kind.” Thus, even such hardware implementation appears to be a result achieved by software. As the Present Specification fails to adequately detail such a “system” as recited by Claim 1, it fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claim 4, Claim 4 recites “a designated filter mode parameter control.” The Present Specification provides no information regarding what the “a designated filter mode parameter control” is, and accordingly does not apprise one of ordinary skill in the art of what Claim 4 contemplates as being done. The term “mode parameter control” appears in the Present Specification only at Paras. [0044] and [0045], where it is referenced as “Mode Parameter Control function 311.” No mention is made regarding what the “filter mode parameter control” is. Accordingly, the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claim 5, Claim 5 recites “the designated filter mode parameter control.” The Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons as explained above with respect to Claim 4. Further, Claim 5 recites “determines the mode parameter control,” which is similarly not described by the Present Specification in a manner as would enable an ordinarily skilled artisan to deduce what is being done.
Regarding Claim 9, Claim 9 recites similar limitations to Claim 4 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
Regarding Claim 10, Claim 10 recites similar limitations to Claim 5 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
Regarding Claim 14, Claim 14 recites similar limitations to Claim 4 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
Regarding Claim 15, Claim 15 recites similar limitations to Claim 5 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
Regarding Claim 20, Claim 20 recites similar limitations to Claim 4 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
Regarding Claim 21, Claim 21 recites similar limitations to Claim 5 and the Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons.
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 4, 5, 9, 10, 14, 15, 18 and 20-21, and Claims 2-3, 6-7, 11-12, 16-17, and 19 by dependency 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 Claim 4, Claim 4 recites “if the input signal exceeds a predetermined threshold.” There is insufficient antecedent basis for the term “the input signal.” It is unclear if the “the input signal” of Claim 4 is the “an electrical input signal including at least one artifact” of Claim 1, the “an input signal waveform,” or something else.
For purposes of this Office Action, the limitation “if the input signal exceeds a predetermined threshold” is being interpreted to mean the “an electrical input signal including at least one artifact.”
Regarding Claim 5:
Claim 5 recites “and the filter mode switch system determines the mode parameter control and the mode adaptive coefficient filter.” There is insufficient antecedent basis for the term “the mode adaptive coefficient filter.” The term “the mode adaptive coefficient filter” is being interpreted to reference the “the mode adaptive coefficient filter system” of Claim 1. It is unclear in what sense “the filter mode switch system” can “determine” another system such as “the mode adaptive coefficient filter system.”
Claim limitation “filter mode switch system” 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 term “filter mode switch system” is described by the Present Specification at Para. [0039] where it is referenced as “filter mode switching system 309.” The only description is this: “…a filter mode switching system 309 which is an automatic and dynamic filter mode switching system….” No mention is made of structure, and it appears that the “filter mode switching system 309” is not a physical system but a result achieved by software. 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.
Regarding Claim 9, Claim 9 recites similar limitations to Claim 4 and is indefinite for the same reasons.
Regarding Claim 10, Claim 10 recites similar limitations to Claim 5 and is indefinite for the same reasons.
Regarding Claim 14, Claim 14 recites similar limitations to Claim 4 and is indefinite for the same reasons.
Regarding Claim 15, Claim 15 recites similar limitations to Claim 5 and is indefinite for the same reasons.
Regarding Claim 18, Claim 18 recites “cause the processor to apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings.” However, Claim 18 defines a “mode adaptive coefficient filter system” in its preamble as “comprising” “a plurality of electrocardiogram ("ECG") electrodes,” “an ECG monitor,” “a display,” and “a processor-based control unit including: a processor; and a memory….” It is unclear in what sense a physical system can be applied by a processor. For example, it is unclear in what sense “a plurality of electrocardiogram ("ECG") electrodes,” “a display,” or “a memory” can be applied by a processor.
Regarding Claim 20, Claim 20 recites similar limitations to Claim 4 and is indefinite for the same reasons.
Regarding Claim 21, Claim 21 recites similar limitations to Claim 5 and is indefinite for the same reasons.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-21 each fall within one of the four categories of statutory subject matter. Claims 1-7 are drawn to a “electrocardiogram monitor” (i.e., a machine), and thus fall within one of the four statutory categories. Claims 8-12 are drawn to a “method” (i.e., a process), and thus fall within one of the four statutory categories. Claims 13-17 are drawn to a “non-transitory computer readable medium” (i.e., a machine), and thus fall within one of the four statutory categories. Claims 18-21 are drawn to a “system” (i.e., a machine), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One
Claims 1-21 recite abstract ideas:
Regarding Independent Claim 1:
“a mode adaptive coefficient filter system for real time electrocardiogram ("ECG") waveform processing of ECG waveforms received from a plurality of ECG electrodes, the mode adaptive coefficient filter system including at least one active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter” recites a mathematical process when afforded its broadest reasonable interpretation. “ A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP 2106.04(a)(2)(I)(C). The recited “mode adaptive coefficient filter” is such an act of calculating using mathematical methods.
Regarding Claims 2-4, Claims 2-4 depend from and further limit Claim 1 and recite abstract ideas for the same reasons as does Claim 1.
Regarding Claim 5:
“determines the mode parameter control and the mode adaptive coefficient filter…” recites a mental process when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). The claimed determining is practically performable in the human mind.
Regarding Claim 6:
“determine the rendered input signal waveform display exceeds the predetermined threshold” recites a mental process when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). The claimed determining is practically performable in the human mind.
Regarding Claim 7, Claim 7 depends from and further limits Claims 1, 5 and 6 and recites an abstract idea for the same reasons as do Claim 1, 5 and 6.
Regarding Independent Claim 8:
“applying a predetermined mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings” recites a mathematical process when afforded its broadest reasonable interpretation. “ A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP 2106.04(a)(2)(I)(C). The recited “mode adaptive coefficient filter” is such an act of calculating using mathematical methods.
“and removing the at least one artifact relative to the waveform display baseline” recites a mental process when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). The claimed removing is practically performable in the human mind
Regarding Claim 9, Claim 9 depends from and further limits Claim 8 and recites an abstract idea for the same reasons as does Claim 8.
Regarding Claim 10:
“determines the mode parameter control and the mode adaptive coefficient filter…” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 5.
Regarding Claim 11:
“determining if the rendered input signal waveform display exceeds the predetermined threshold” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 6.
Regarding Claim 12, Claim 12 depends from and further limits Claims 8, 10 and 11 and recites an abstract idea for the same reasons as do Claims 8, 10 and 11.
Regarding Independent Claim 13:
“applying a predetermined mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings” recites a mathematical calculation for the same reasons as explained above with respect to the similar limitation of Claim 8.
“removing the at least one artifact relative to the waveform display baseline” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 8.
Regarding Claim 14, Claim 14 depends from and further limits Claim 13 and recites an abstract idea for the same reasons as does Claim 13.
Regarding Claim 15:
“determines the mode parameter control and the mode adaptive coefficient filter” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 5.
Regarding Claim 16:
“determining if the rendered input signal waveform display exceeds the predetermined threshold” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 6
Regarding Claim 17, Claim 17 depends from and further limits Claims 13, 15 and 16 and recites an abstract idea for the same reasons as do Claims 13, 15 and 16.
Regarding Independent Claim 18:
“at least one active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter” recites a mathematical calculation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claims 19 and 20, Claims 19 and 20 depend from and further limit Claim 18 and recite an abstract idea for the same reasons as does Claim 18.
Regarding Claim 21:
“determines the mode parameter control and the mode adaptive coefficient filter” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 5.
Eligibility Step 2A, Prong Two
Claims 1-21 do not recite additional elements that integrate the judicial exception into a practical application.
Regarding Independent Claim 1:
“a mode adaptive coefficient filter system…” (i.e., that the “mode adaptive coefficient filter” is implemented as a “system”) recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“a display” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“a processor-based control unit” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“programmed to: monitor a plurality of ECG electrodes when the ECG electrodes are ostensibly electrically connected” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings” amounts to mere instructions to implement an abstract idea on a computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. See MPEP 2106.05(f).
“and render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claim 2:
“further comprising the plurality of ECG electrodes” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claim 3:
“a processor” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“a memory” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Regarding Claims 4-5, Claims 4-5 do not recite any additional elements.
Regarding Claim 6:
“issue an alarm” is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
The Examiner notes that the “alarm” as recited does not appear to be issued explicitly based on any particular determination. If the alarm is indeed based on such a determination, and the claim were clarified to this effect, the recited “alarm” may potentially be sufficient to integrate the recited abstract idea into a practical application.
Regarding Claim 7, Claim 7 does not recite any additional elements.
Regarding Independent Claim 8:
“monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patient monitoring ("PPM") product ostensibly electrically connected to a human body …” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“rendering an input signal waveform in a display” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claims 9-10, Claims 9-10 do not recite any additional elements.
Regarding Claim 11:
“issuing an alarm” is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
The Examiner notes that the “alarm” as recited does not appear to be issued explicitly based on any particular determination. If the alarm is indeed based on such a determination, and the claim were clarified to this effect, the recited “alarm” may potentially be sufficient to integrate the recited abstract idea into a practical application.
Regarding Claim 12, Claim 12 does not recite any additional elements.
Regarding Independent Claim 13:
“A non-transitory computer readable medium” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patent monitoring ("PPM") product” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“ receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“rendering an input signal waveform in a display” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claims 14-15, Claims 14-15 do not recite any additional elements.
Regarding Claim 16:
“issuing an alarm” is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
The Examiner notes that the “alarm” as recited does not appear to be issued explicitly based on any particular determination. If the alarm is indeed based on such a determination, and the claim were clarified to this effect, the recited “alarm” may potentially be sufficient to integrate the recited abstract idea into a practical application
Regarding Claim 17, Claim 17 does not recite any additional elements.
Regarding Claim 18:
“a plurality of electrocardiogram ("ECG") electrodes in a physiological patient monitoring ("PPM") product” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“an ECG monitor” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“a display” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
“a processor-based control unit including: a processor; and a memory” recites generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Regarding Claim 19:
“receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“apply the mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings” amounts to mere instructions to implement an abstract idea on a computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. See MPEP 2106.05(f).
“render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claims 20-21, Claims 20-21 do not recite any additional elements.
Eligibility Step 2B
Claims 1-21 do not amount to significantly more than the abstract ideas recited therein.
Regarding Independent Claim 1:
“a mode adaptive coefficient filter system…” (i.e., that the “mode adaptive coefficient filter” is implemented as a “system”) does not contribute an inventive concept. The claimed system is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a system amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“a display” does not contribute an inventive concept. The claimed display is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a display amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“a processor-based control unit” does not contribute an inventive concept. The claimed processor-based control unit is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a processor-based control unit amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“programmed to: monitor a plurality of ECG electrodes when the ECG electrodes are ostensibly electrically connected” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” does not contribute an inventive concept. Such signal acquisition is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings” amounts to mere instructions to implement an abstract idea on a computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. See MPEP 2106.05(f).
“and render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline” does not contribute an inventive concept. Such rendering is well-understood, routine and conventional in the art. See, e.g., US 4414981 A at Col. 1, Ln. 31-33, “It is well-known to place electrodes on the patient's skin to sense the ECG signals and to present them for visual analysis…”).
Regarding Claim 2:
“further comprising the plurality of ECG electrodes” does not contribute an inventive concept. Such electrodes are well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
Regarding Claim 3:
“a processor” does not contribute an inventive concept. The claimed processor is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a processor amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“a memory” does not contribute an inventive concept. The claimed memory is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a memory amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
Regarding Claims 4-5, Claims 4-5 do not recite any additional elements.
Regarding Claim 6:
“issue an alarm” does not contribute an inventive concept. Such an alarm is well-understood, routine and conventional in the art. See, e.g., US 2021/0057085 A1 at Para. [0003] (“Typically, subject-monitoring devices are able to generate alarm events indicative of the subject or the subject-monitoring device entering a non-desirable state.”).
Regarding Claim 7, Claim 7 does not recite any additional elements.
Regarding Independent Claim 8:
“monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patient monitoring ("PPM") product ostensibly electrically connected to a human body …” does not contribute an inventive concept. Such monitoring is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” does not contribute an inventive concept. Such receiving is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“rendering an input signal waveform in a display” does not contribute an inventive concept. Such rendering is well-understood, routine and conventional in the art. See, e.g., US 4414981 A at Col. 1, Ln. 31-33, “It is well-known to place electrodes on the patient's skin to sense the ECG signals and to present them for visual analysis…”).
Regarding Claims 9-10, Claims 9-10 do not recite any additional elements.
Regarding Claim 11:
“issuing an alarm” does not contribute an inventive concept. Such an alarm is well-understood, routine and conventional in the art. See, e.g., US 2021/0057085 A1 at Para. [0003] (“Typically, subject-monitoring devices are able to generate alarm events indicative of the subject or the subject-monitoring device entering a non-desirable state.”).
Regarding Claim 12, Claim 12 does not recite any additional elements.
Regarding Independent Claim 13:
“A non-transitory computer readable medium” does not contribute an inventive concept. The claimed non-transitory computer readable medium is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a non-transitory computer readable medium amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patent monitoring ("PPM") product” does not contribute an inventive concept. Such monitoring is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal” does not contribute an inventive concept. Such receiving is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002]
“rendering an input signal waveform in a display” does not contribute an inventive concept. Such rendering is well-understood, routine and conventional in the art. See, e.g., US 4414981 A at Col. 1, Ln. 31-33, “It is well-known to place electrodes on the patient's skin to sense the ECG signals and to present them for visual analysis…”).
Regarding Claims 14-15, Claims 14-15 do not recite any additional elements.
Regarding Claim 16:
“issuing an alarm” does not contribute an inventive concept. Such an alarm is well-understood, routine and conventional in the art. See, e.g., US 2021/0057085 A1 at Para. [0003] (“Typically, subject-monitoring devices are able to generate alarm events indicative of the subject or the subject-monitoring device entering a non-desirable state.”).
Regarding Claim 17, Claim 17 does not recite any additional elements.
Regarding Claim 18:
“a plurality of electrocardiogram ("ECG") electrodes in a physiological patient monitoring ("PPM") product” does not contribute an inventive concept. Such electrodes are well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“an ECG monitor” does not contribute an inventive concept. Such an ECG monitor is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“a display” does not contribute an inventive concept. The claimed display is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a display amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
“a processor-based control unit including: a processor; and a memory” does not contribute an inventive concept. The claimed processor-based control unit is a generic computer component for performing a generic computer function, and is recited at a high level of generality. Contextually, the inclusion of such a processor-based control unit amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
Regarding Claim 19:
“receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline” does not contribute an inventive concept. Such receiving is well-understood, routine and conventional in the art. See, e.g., US 2014/0276161 A1 at Para. [0002].
“apply the mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings” amounts to mere instructions to implement an abstract idea on a computer. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application in Step 2A Prong Two or add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. See MPEP 2106.05(f).
“render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline” does not contribute an inventive concept. Such rendering is well-understood, routine and conventional in the art. See, e.g., US 4414981 A at Col. 1, Ln. 31-33, “It is well-known to place electrodes on the patient's skin to sense the ECG signals and to present them for visual analysis…”).
Regarding Claims 20-21, Claims 20-21 do not recite any additional elements.
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.
Claims 8-10 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0142395 A1 to Sattler et al.1 (“Sattler”).
Regarding Independent Claim 8, Sattler teaches:
A method for real time electrocardiogram ("ECG") waveform processing, comprising: (Title, “Apparatus and method for data processing of physiological signals;” Para. [0034], “In this exemplary embodiment, the goal of filtering according to the present invention is to remove the ECG artifacts caused by the heartbeat of the patient, especially the R waves, without major time delay, without compromising the useful signal.”);
monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patent monitoring ("PPM") product ostensibly electrically connected to a human body and including an active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter; (Para. [0061]; Para. [0034]; Para. [0002], “The present invention pertains, in general, to the area of the processing of physiological signals and especially to an apparatus and to a method for processing physiological signals, especially physiological signals of human beings, for therapeutic and diagnostic applications as well as monitoring applications (“monitoring”);” Para. [0094]);
receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline; (Para. [0036], “The above problem is solved by the signal path being divided during filtering into a plurality of separate signal paths, namely, into a fast signal path and at least one slow signal path. The signal paths act on the same noise-affected input signal, which contains both a useful component and a noise component (e.g., ECG artifacts);” Para. [0038], “To remove ECG artifacts from an EMG useful signal, the signal paths are adapted to the signal components of the ECG signal and of the EMG signal.”);
The term “relative to a waveform display baseline” is being interpreted to mean that the recited “artifact” is an artifact “relative to a waveform display baseline,” in that it deviates from an expected baseline.
applying a predetermined mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings; (Para. [0063], “…filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts (e.g., the R waves) caused by the patient's heartbeat without major time delay, without compromising the useful signal in the process;” Para. [0064]);
rendering an input signal waveform in a display; (Fig. 5B; Para. [0075]);
and removing the at least one artifact relative to the waveform display baseline. (Fig. 5B; Para. [0075], “The result of the filtering is shown in FIG. 5B: The signal components indicated by dots were removed.”).
Regarding Claim 9, Sattler discloses the entirety of Claim 8 as explained above.
Sattler additionally teaches:
wherein applying the predetermined mode adaptive coefficient filter includes applying the predetermined mode adaptive coefficient filter based on a designated filter mode parameter control if the input signal exceeds a predetermined threshold (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Regarding Claim 10, Sattler discloses the entirety of Claim 9 as explained above.
Sattler additionally teaches:
wherein: ascertaining the filter mode parameter control includes a selection from a filter mode switch system or a user interface; (Para. [0099], “For artifacts that are, e.g., so small that they cannot be accurately detected by means of a threshold (e.g., P waves), it is possible to cut out the artifact hardly by means of an expectation window determined from the slow path (or of a gradual probability curve) and to replace it by a simulated useful signal or to make it inactive in another manner by adaption of signal processing methods. The latter can be performed by switching the filter characteristic…”);
and the filter mode switch system determines the mode parameter control and the mode adaptive coefficient filter when the input signal waveform is displayed out of the predetermined threshold. (Para. [0083], “To obtain the exact time of the maximum and the corresponding value, a comparison is made with the original signal in unit 610 for determining the value and the time of the ECG. This information is then used in the threshold value calculation to determine a suitable threshold value for the removal of the ECG in the fast signal path 602.”).
Regarding Independent Claim 13, Sattler teaches:
A non-transitory computer readable medium encoded with instructions that, when executed by a processor, perform a method for real time electrocardiogram ("ECG") waveform processing, comprising: (Title, “Apparatus and method for data processing of physiological signals;” Para. [0034], “In this exemplary embodiment, the goal of filtering according to the present invention is to remove the ECG artifacts caused by the heartbeat of the patient, especially the R waves, without major time delay, without compromising the useful signal;” Para. [0030], “Furthermore, also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor) in various embodiments of filter types.”);
monitoring a plurality of electrocardiogram ("ECG") electrodes in a physiological patent monitoring ("PPM") product ostensibly electrically connected to a human body and including an active n-order impulse filter; (Para. [0061]; Para. [0034]; Para. [0002], “The present invention pertains, in general, to the area of the processing of physiological signals and especially to an apparatus and to a method for processing physiological signals, especially physiological signals of human beings, for therapeutic and diagnostic applications as well as monitoring applications (“monitoring”);” Para. [0094])
The term “ostensibly electrically connected” is being interpreted in accordance with the special definition set forth at Para. [0021] of the Present Specification.
Sattler’s device performs monitoring “when the ECG electrodes are ostensibly electrically connected” by virtue of its “real-time” monitoring, which requires such electrical connection
the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter; (Para. [0030]);
receiving a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline; (Para. [0036], “The above problem is solved by the signal path being divided during filtering into a plurality of separate signal paths, namely, into a fast signal path and at least one slow signal path. The signal paths act on the same noise-affected input signal, which contains both a useful component and a noise component (e.g., ECG artifacts);” Para. [0038], “To remove ECG artifacts from an EMG useful signal, the signal paths are adapted to the signal components of the ECG signal and of the EMG signal.”);
The term “relative to a waveform display baseline” is being interpreted to mean that the recited “artifact” is an artifact “relative to a waveform display baseline,” in that it deviates from an expected baseline
applying a predetermined mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings; (Para. [0063], “…filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts (e.g., the R waves) caused by the patient's heartbeat without major time delay, without compromising the useful signal in the process;” Para. [0064]);
rendering an input signal waveform in a display; (Fig. 5B; Para. [0075], “The result of the filtering is shown in FIG. 5B: The signal components indicated by dots were removed.”).
and removing the at least one artifact relative to the waveform display baseline. (Fig. 5B; Para. [0075], “The result of the filtering is shown in FIG. 5B: The signal components indicated by dots were removed.”).
Regarding Claim 14, Sattler discloses the entirety of Claim 13 as explained above.
Sattler additionally teaches:
wherein applying the predetermined mode adaptive coefficient filter includes applying the predetermined mode adaptive coefficient filter based on a designated filter mode parameter control if the input signal exceeds a predetermined threshold (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Regarding Claim 15, Sattler discloses the entirety of Claim 14 as explained above.
Sattler additionally teaches:
wherein: ascertaining the filter mode parameter control includes a selection from a filter mode switch system or a user interface; (Para. [0099], “For artifacts that are, e.g., so small that they cannot be accurately detected by means of a threshold (e.g., P waves), it is possible to cut out the artifact hardly by means of an expectation window determined from the slow path (or of a gradual probability curve) and to replace it by a simulated useful signal or to make it inactive in another manner by adaption of signal processing methods. The latter can be performed by switching the filter characteristic…”);
and the filter mode switch system determines the mode parameter control and the mode adaptive coefficient filter when the input signal waveform is displayed out of the predetermined threshold. (Para. [0083], “To obtain the exact time of the maximum and the corresponding value, a comparison is made with the original signal in unit 610 for determining the value and the time of the ECG. This information is then used in the threshold value calculation to determine a suitable threshold value for the removal of the ECG in the fast signal path 602.”).
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.
Claims 1-7, 11-12 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0142395 A1 to Sattler et al. (“Sattler”) in view of US 2011/0144461 A12 to Oh et al. (“Oh”).
Regarding Independent Claim 1, Sattler teaches:
An electrocardiogram ("ECG") monitor, comprising: (Title, “Apparatus and method for data processing of physiological signals;” Para. [0034], “In this exemplary embodiment, the goal of filtering according to the present invention is to remove the ECG artifacts caused by the heartbeat of the patient, especially the R waves, without major time delay, without compromising the useful signal.”);
a mode adaptive coefficient filter system for real time electrocardiogram ("ECG") waveform processing of ECG waveforms received from a plurality of ECG electrodes, (Para. [0061], “The filter apparatus 100 has a fast signal path 102 and at least one slow signal path 103, which are arranged in parallel. The signal paths 102 and 103 act on the same noise-affected input signal 101, which contains both a useful component and a noise component. … A filter possessing nonlinear properties is preferably used at least in the fast signal path 102. The known methods of linear filtering, including adaptive filter, may be used in the slow signal path 103, because the longer delay time plays no role;” Para. [0034]);
Sattler’s “filter apparatus 100” is such a “mode adaptive coefficient filter system” as claimed.
the mode adaptive coefficient filter system including at least one active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter; (Para. [0030], “Furthermore, also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor) in various embodiments of filter types. Such filter types based on programmable source codes include, for example, FIR filters (Finite Impulse Response), IIR filters (Infinite Impulse Response),…” (emphasis added));
a processor-based control unit programmed to: monitor a plurality of ECG electrodes when the ECG electrodes are ostensibly electrically connected; (Para. [0062], “The filter apparatus 100 from FIG. 1A is preferably used in the real-time filtering of physiological signals, for example, during the filtering of electromyographic signals from a patient, which are used to drive a respirator on the basis of the correspondingly filtered electromyographic signals;” Para. [0063], “… filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts…” Para. [0030], “…also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor)…”);
The term “ostensibly electrically connected” is being interpreted in accordance with the special definition set forth at Para. [0021] of the Present Specification.
Sattler’s device performs monitoring “when the ECG electrodes are ostensibly electrically connected” by virtue of its “real-time” monitoring, which requires such electrical connection.
receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline; (Para. [0036], “The above problem is solved by the signal path being divided during filtering into a plurality of separate signal paths, namely, into a fast signal path and at least one slow signal path. The signal paths act on the same noise-affected input signal, which contains both a useful component and a noise component (e.g., ECG artifacts);” Para. [0038], “To remove ECG artifacts from an EMG useful signal, the signal paths are adapted to the signal components of the ECG signal and of the EMG signal.”);
The term “relative to a waveform display baseline” is being interpreted to mean that the recited “artifact” is an artifact “relative to a waveform display baseline,” in that it deviates from an expected baseline.
apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings; (Para. [0063], “…filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts (e.g., the R waves) caused by the patient's heartbeat without major time delay, without compromising the useful signal in the process;” Para. [0064]);
Sattler’s “fast signal path” and “slow signal path” configuration discussed at Para. [0064] is such a “plurality of preconfigured filter parameter settings” as claimed.
and render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline. (Fig. 5B; Para. [0075], “The result of the filtering is shown in FIG. 5B: The signal components indicated by dots were removed.”).
Although Sattler does not explicitly teach a display (one is implied at Para. [0002] and Figs. 5A-5C), Sattler describes displaying the results of Sattler’s filtering.
Sattler does not disclose:
a display;
Oh describes “a method for measuring a correct pulse frequency when noise is included in a bio-signal and an apparatus therefor” (Para. [0003]) in the context of ECG (Para. [0033]). Oh is analogous art.
Oh teaches:
a display; (Fig. 1, “display unit 100;” Para. [0030], “The display unit 100 displays a bio-signal or bio-information input from the bio-signal processor 40.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sattler with the teachings of Oh (i.e., to include such a display as taught by Oh in the device of Sattler) in order to display input from the processor (Oh at Para. [0030]), and more particularly to display Sattler’s input signal shown in Sattler’s Fig. 5B.
Regarding Claim 2, the combination of Sattler and Oh renders obvious the entirety of Claim 1 as explained above.
Sattler additionally teaches:
further comprising the plurality of ECG electrodes. (Para. [0094], “…line artifact parameters for quantifying the degree of interference with the physiological signal due to line artifacts (50/60 Hz), e.g., for recognizing electrodes that have become loose or have even fallen off…”).
Sattler’s described recognition of electrodes that have become loose or have even fallen off shows that such a plurality of ECG electrodes as recited by Claim 2 are comprised by Sattler’s system.
Regarding Claim 3, the combination of Sattler and Oh renders obvious the entirety of Claim 1 as explained above.
Sattler additionally teaches:
further comprising: a processor; and a memory in which resides a plurality of instructions with which the processor- based control unit is programmed and that, when executed by the processor, cause the processor to apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings. (Para. [0030], “…also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor)…”).
Regarding Claim 4, the combination of Sattler and Oh renders obvious the entirety of Claim 1 as explained above.
Sattler additionally teaches:
wherein the processor-based control unit is further programmed to apply the mode adaptive coefficient filter based on a designated filter mode parameter control if the input signal exceeds a predetermined threshold (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Regarding Claim 5, the combination of Sattler and Oh renders obvious the entirety of Claim 4 as explained above.
Sattler additionally teaches:
wherein: the filter mode parameter control includes a selection from a filter mode switch system or a user interface; (Para. [0099], “For artifacts that are, e.g., so small that they cannot be accurately detected by means of a threshold (e.g., P waves), it is possible to cut out the artifact hardly by means of an expectation window determined from the slow path (or of a gradual probability curve) and to replace it by a simulated useful signal or to make it inactive in another manner by adaption of signal processing methods. The latter can be performed by switching the filter characteristic…”);
and the filter mode switch system determines the mode parameter control and the mode adaptive coefficient filter when the input signal waveform is displayed out of the predetermined threshold. (Para. [0083], “To obtain the exact time of the maximum and the corresponding value, a comparison is made with the original signal in unit 610 for determining the value and the time of the ECG. This information is then used in the threshold value calculation to determine a suitable threshold value for the removal of the ECG in the fast signal path 602.”).
Regarding Claim 6, the combination of Sattler and Oh renders obvious the entirety of Claim 5 as explained above.
Sattler additionally teaches:
wherein the processor-based control unit is further programmed to: determine the rendered input signal waveform display exceeds the predetermined threshold; (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Oh additionally teaches:
and issue an alarm (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Sattler and Oh with the teachings of Oh (i.e., to issue an alarm in the manner of Oh) in order to alert operators to potential error (Oh at Para. [0054]).
Regarding Claim 7, the combination of Sattler and Oh renders obvious the entirety of Claim 6 as explained above.
Oh additionally teaches:
wherein the alarm is an audio alarm, a visual alarm on the display, or a combination of the audio alarm and the visual alarm (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
Regarding Claim 11, Sattler discloses the entirety of Claim 10 explained above.
Sattler additionally teaches:
further comprising determining if the rendered input signal waveform display exceeds the predetermined threshold; (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Satler does not disclose:
issuing an alarm
Oh describes “a method for measuring a correct pulse frequency when noise is included in a bio-signal and an apparatus therefor” (Para. [0003]) in the context of ECG (Para. [0033]). Oh is analogous art.
Oh teaches:
issuing an alarm (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device Sattler with the teachings of Oh (i.e., to issue an alarm in the manner of Oh) in order to alert operators to potential error (Oh at Para. [0054]).
Regarding Claim 12, the combination of Sattler and Oh renders obvious the entirety of Claim 11 as explained above.
Oh additionally teaches:
wherein issuing the alarm includes sounding an audio alarm, presenting a visual alarm on the display; or a combination of sounding the audio alarm and presenting the visual alarm on the display. (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
Regarding Claim 16, Sattler discloses the entirety of Claim 15 explained above.
Sattler additionally teaches:
wherein the instructions further include, when executed by the processor, determining if the rendered input signal waveform display exceeds the predetermined threshold; (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Satler does not disclose:
And issuing an alarm
Oh describes “a method for measuring a correct pulse frequency when noise is included in a bio-signal and an apparatus therefor” (Para. [0003]) in the context of ECG (Para. [0033]). Oh is analogous art.
Oh teaches:
And issuing an alarm (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device Sattler with the teachings of Oh (i.e., to issue an alarm in the manner of Oh) in order to alert operators to potential error (Oh at Para. [0054]).
Regarding Claim 17, the combination of Sattler and Oh renders obvious the entirety of Claim 16 as explained above.
Oh additionally teaches:
wherein the instructions further include, when executed by the processor, issuing the alarm by sounding an audio alarm; or presenting a visual alarm on the display; or a combination of sounding the audio alarm and presenting the visual alarm on the display. (Para. [0054], “In addition, the bio-signal decider 90 controls the alarm generator 110 to generate an alarm sound for alarming that a currently calculated pulse frequency may be incorrect, for the degeneration period and the impulse noise period.”).
Regarding Independent Claim 18, Sattler teaches:
A mode adaptive coefficient filter system for real time electrocardiogram ("ECG") waveform processing, comprising: (Title, “Apparatus and method for data processing of physiological signals;” Para. [0034], “In this exemplary embodiment, the goal of filtering according to the present invention is to remove the ECG artifacts caused by the heartbeat of the patient, especially the R waves, without major time delay, without compromising the useful signal.”);
a plurality of electrocardiogram ("ECG") electrodes in a physiological patient monitoring ("PPM") product ostensibly electrically connected to a human body; (Para. [0061]; Para. [0034]; Para. [0002], “The present invention pertains, in general, to the area of the processing of physiological signals and especially to an apparatus and to a method for processing physiological signals, especially physiological signals of human beings, for therapeutic and diagnostic applications as well as monitoring applications (“monitoring”);” Para. [0094])
The term “ostensibly electrically connected” is being interpreted in accordance with the special definition set forth at Para. [0021] of the Present Specification.
Sattler’s device performs monitoring “when the ECG electrodes are ostensibly electrically connected” by virtue of its “real-time” monitoring, which requires such electrical connection
an ECG monitor electrically connected to the ECG electrodes, the ECG monitor including:at least one active n-order impulse filter, the n-order impulse filter being one of an infinite impulse response ("IIR") filter and a finite impulse response ("FIR") filter; (Para. [0061]; Para. [0034]; Para. [0002], “The present invention pertains, in general, to the area of the processing of physiological signals and especially to an apparatus and to a method for processing physiological signals, especially physiological signals of human beings, for therapeutic and diagnostic applications as well as monitoring applications (“monitoring”);” Para. [0094]);
and a processor-based control unit including: a processor; and a memory in which resides a plurality of instructions with which the processor-based control unit is programmed and that, when executed by the processor, cause the processor to apply the mode adaptive coefficient filter system based on a plurality of preconfigured filter parameter settings. (Para. [0030], “Furthermore, also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor) in various embodiments of filter types;” Para. [0063], “…filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts (e.g., the R waves) caused by the patient's heartbeat without major time delay, without compromising the useful signal in the process;” Para. [0064]);
Sattler does not disclose:
a display;
Oh describes “a method for measuring a correct pulse frequency when noise is included in a bio-signal and an apparatus therefor” (Para. [0003]) in the context of ECG (Para. [0033]). Oh is analogous art.
Oh teaches:
a display; (Fig. 1, “display unit 100;” Para. [0030], “The display unit 100 displays a bio-signal or bio-information input from the bio-signal processor 40.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sattler with the teachings of Oh (i.e., to include such a display as taught by Oh in the device of Sattler) in order to display input from the processor (Oh at Para. [0030]), and more particularly to display Sattler’s input signal shown in Sattler’s Fig. 5B.
Regarding Claim 19, the combination of Sattler and Oh renders obvious the entirety of Claim 18 as explained above.
Sattler additionally teaches:
wherein the processor-based control unit is programmed to: monitor the ECG electrodes when the ECG electrodes are ostensibly electrically connected; (Para. [0062], “The filter apparatus 100 from FIG. 1A is preferably used in the real-time filtering of physiological signals, for example, during the filtering of electromyographic signals from a patient, which are used to drive a respirator on the basis of the correspondingly filtered electromyographic signals;” Para. [0063], “… filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts…” Para. [0030], “…also included as possibilities of signal filtering and real-time filtering in the sense of the present invention are various types of digital filtering, which are carried out after an analog-to-digital conversion in the form of a software-implemented filtering by a process control in the form of a programmable source code, in which filter coefficients and/or mathematical equation models are contained, which are carried out by means of a μP (microprocessor), μC (microcontroller) or a DSP (Digital Signal Processor)…”);
receive a physiological signal acquired from one of the ECG electrodes as an electrical input signal including at least one artifact relative to a waveform display baseline; (Para. [0036], “The above problem is solved by the signal path being divided during filtering into a plurality of separate signal paths, namely, into a fast signal path and at least one slow signal path. The signal paths act on the same noise-affected input signal, which contains both a useful component and a noise component (e.g., ECG artifacts);” Para. [0038], “To remove ECG artifacts from an EMG useful signal, the signal paths are adapted to the signal components of the ECG signal and of the EMG signal.”);
The term “relative to a waveform display baseline” is being interpreted to mean that the recited “artifact” is an artifact “relative to a waveform display baseline,” in that it deviates from an expected baseline.
apply the mode adaptive coefficient filter based on a plurality of preconfigured filter parameter settings; (Para. [0063], “…filter apparatus 100 from FIG. 1A may be used with the aim of removing the ECG artifacts (e.g., the R waves) caused by the patient's heartbeat without major time delay, without compromising the useful signal in the process;” Para. [0064]);
Sattler’s “fast signal path” and “slow signal path” configuration discussed at Para. [0064] is such a “plurality of preconfigured filter parameter settings” as claimed.
and render an input signal waveform in the display that removes the at least one artifact relative to the waveform display baseline. (Fig. 5B; Para. [0075], “The result of the filtering is shown in FIG. 5B: The signal components indicated by dots were removed.”).
Regarding Claim 20, the combination of Sattler and Oh renders obvious the entirety of Claim 19 as explained above.
Sattler additionally teaches:
wherein the processor-based control unit further programmed to apply the predetermined mode adaptive coefficient filter based on a designated filter mode parameter control if the input signal exceeds a predetermined threshold. (Para. [0075], “A nonlinear filter based on a outlier analysis (comparison with a fixed threshold, horizontal line drawn in a broken line) is embodied in the fast signal path in order to remove the R waves of the ECG (FIG. 5A, t=50, t=120, t=290);” Paras. [0076] through [0077]).
Regarding Claim 21, the combination of Sattler and Oh renders obvious the entirety of Claim 20 as explained above.
Sattler additionally teaches:
wherein: the filter mode parameter control includes a selection from a filter mode switch system or a user interface; (Para. [0099], “For artifacts that are, e.g., so small that they cannot be accurately detected by means of a threshold (e.g., P waves), it is possible to cut out the artifact hardly by means of an expectation window determined from the slow path (or of a gradual probability curve) and to replace it by a simulated useful signal or to make it inactive in another manner by adaption of signal processing methods. The latter can be performed by switching the filter characteristic…”);
and the filter mode switch system determines the mode parameter control and the mode adaptive coefficient filter when the input signal waveform is displayed out of the predetermined threshold. (Para. [0083], “To obtain the exact time of the maximum and the corresponding value, a comparison is made with the original signal in unit 610 for determining the value and the time of the ECG. This information is then used in the threshold value calculation to determine a suitable threshold value for the removal of the ECG in the fast signal path 602.”).
Art Made of Record Although Not Relied Upon
The Examiner notes the relevance of the following prior art, which are made of record herein although not relied upon in any current rejection:
US 2011/0257552 A1 to Banet et al. describes a “a system for measuring respiratory rate (RR) from a patient” which employs a “a digital adaptive filter” (Para. [0027] that uses second-order infinite impulse response (IIR) (Para. [0093]) and finite impulse response (Para. [0166]).
US 5983127 A to dePinto describes “A noise detection system having a baseline wander filter, high and low pass filters, an adaptive line noise canceler and various noise detectors is provided to identify, signal and remove contamination from an ECG signal…” (Abstract).
US 20050240087 A1 to Keenan et al. describes “…methods and systems for the analysis of data returned from monitoring multiple physiological parameters of a subject…” (Abstract) in the context of ECG (Para. [0025]) and uses a filter that “…may be finite impulse response (FIR) type or infinite impulse response type (IIR)…” (Para. [0088]).
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 US 2014/0142395 A1 was disclosed by Applicant in the IDS dated 1/8/2025.
2 US 2011/0144461 A1 was disclosed by Applicant in the IDS dated 1/8/2025.
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