DETAILED ACTION
Claims 1-12 are hereby under examination.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2024 is being considered by the examiner.
Claim Objections
Claims 8 and 10 are objected to because of the following informalities:
Regarding claim 8, line 25 recites “ripple_down2).”, however it appears it should read --ripple_down2),-- (emphasis added).
Regarding claim 10, lines 28-29 recite “a hemodynamic parameter (SV) correlated with a fluid responsiveness parameter (SPV, PPV)”, however it appears it should read --the hemodynamic parameter (SV) correlated with the fluid responsiveness parameter (SPV, PPV)-- (emphasis added).
Claim Interpretation - 35 USC § 112(f)
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:
Claim 1: The claim limitation “a respiratory rate provider configured to provide a respiratory rate” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide a respiratory rate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 1: The claim limitation “a heart rate provider configured to provide a heart rate” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide a heart rate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 1: The claim limitation “a blood pulsation signal provider configured to provide a blood pulsation signal …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide a blood pulsation signal …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 1: The claim limitation “a processed signal determiner configured to determine a first processed signal … and a second processed signal …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “determiner” coupled with functional language “configured to determine a first processed signal … and a second processed signal …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “determiner”.
Claim 1: The claim limitation “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “determiner” coupled with functional language “configured to determine the fluid responsiveness parameter …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “determiner”.
Claim 5: The claim limitation “a blood pressure characteristic provider for providing a blood pressure characteristic” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “for providing a blood pressure characteristic” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a respiratory rate provider configured to provide the respiratory rate …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide the respiratory rate …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a heart rate provider configured to provide the heart rate …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide the heart rate …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a processed signal provider configured to provide the first and second processed signals …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide the first and second processed signals …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a second fluid responsiveness parameter determination signal provider configured to provide the second fluid responsiveness parameter determination signals …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide the second fluid responsiveness parameter determination signals …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a reliability determiner configured to determine the reliability …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “determiner” coupled with functional language “configured to determine the reliability …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “determiner”.
Claim 8: The claim limitation “a first model provider configured to provide a first model …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide a first model …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a second model provider configured to provide a second model …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “provider” coupled with functional language “configured to provide a second model …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “provider”.
Claim 8: The claim limitation “a combined model determiner configured to determine a combined model …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “determiner” coupled with functional language “configured to determine a combined model …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “determiner”.
Claim 8: The claim limitation “a hemodynamic parameter determiner configured to determine the hemodynamic parameter …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “determiner” coupled with functional language “configured to determine the hemodynamic parameter …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “determiner”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“the blood pulsation signal can be provided based on a measurement using a dedicated cuff system …”, or equivalents thereof, as described on pg. 14 of the disclosure filed on 12/17/2024.
Regarding a-b and d-o, the specification does not provide adequate structure for performing the claimed functions. For the purposes of examination, any element capable of or configured to perform the claimed functions is being interpreted as the corresponding structure.
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(a)
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 1-8 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112(f):
Claim 1: “a respiratory rate provider configured to provide a respiratory rate”;
Claim 1: “a heart rate provider configured to provide a heart rate”;
Claim 1: “a processed signal determiner configured to determine a first processed signal … and a second processed signal …”;
Claim 1: “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter …”;
Claim 5: “a blood pressure characteristic provider for providing a blood pressure characteristic”;
Claim 8: “a respiratory rate provider configured to provide the respiratory rate …”;
Claim 8: “a heart rate provider configured to provide the heart rate …”;
Claim 8: “a processed signal provider configured to provide the first and second processed signals …”;
Claim 8: “a second fluid responsiveness parameter determination signal provider configured to provide the second fluid responsiveness parameter determination signals …”;
Claim 8: “a reliability determiner configured to determine the reliability …”;
Claim 8: “a first model provider configured to provide a first model …”;
Claim 8: “a second model provider configured to provide a second model …”
Claim 8: “a combined model determiner configured to determine a combined model …”; and
Claim 8: “a hemodynamic parameter determiner configured to determine the hemodynamic parameter …”.
The specification merely discloses the functions performed by these limitations. See at least pgs. 7, 11, 12, 14, 15, 17, and 26. However, one of ordinary skill in the art would not understand the specification, the drawings, and the original claims to disclose any particular structure that achieves the disclosed functionality.
The limitations fail to comply with the written description requirement as the limitations are unbound functional limitations which cover all ways of performing the respective functions and the inventor has not provided sufficient disclosure to show possession of such invention. The limitations therefore fail to comply with the written description requirement. See MPEP 2181.II.A.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-8, the claims recite limitations that invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, as recited above. 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. As recited above, the specification fails to provide adequate structures for performing the claimed functions. 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.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 4, the claim recites “the processed signal determiner is configured to determine a first processed signal …”. However, claim 1 recites “a processed signal determiner configured to determine a first processed signal …”. In light of the specification, it is currently unclear if the determined first processed signals are the same, related, or different. For the purposes of examination, the two recitations of “first processed signal” are being interpreted as being related.
Regarding claim 4, the claim recites “the processed signal determine is configured to determine … a second processed signal …”. However, claim 1 recites “a processed signal determine configured to determine … a second processed signal …”. In light of the specification, it is currently unclear if the determined second processed signals are the same, related, or different. For the purposes of examination, the two recitations of “second processed signal” are being interpreted as being related.
Regarding claim 4, the claim recites “the fluid responsiveness parameter determine is configured to determine the responsiveness parameter (SPV) by: a’) identifying a first fluid responsiveness parameter determination signal …”. However, claim 1 recites “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter (SPV, PPV) by: a) identifying first fluid responsiveness parameter determination signals …”. In light of the specification, it is currently unclear if “first fluid responsiveness parameter determination signal” are the same, related, or different. For the purposes of examination, the two recitations of “first fluid responsiveness parameter determination signal” are being interpreted as being related.
Regarding claim 4, the claim recites “the fluid responsiveness parameter determine is configured to determine the responsiveness parameter (SPV) by: a’) identifying … a second fluid responsiveness parameter determination signal”. However, claim 1 recites “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter (SPV, PPV) by: a) identifying … second fluid responsiveness parameter determination signals”. In light of the specification, it is currently unclear if “second fluid responsiveness parameter determination signal” are the same, related, or different. For the purposes of examination, the two recitations of “second fluid responsiveness parameter determination signal” are being interpreted as being related.
Regarding claim 6, the claim recites “the processed signal determiner is configured to determine a first processed signal …”. However, claim 1 recites “a processed signal determiner configured to determine a first processed signal …”. In light of the specification, it is currently unclear if the determined first processed signals are the same, related, or different. For the purposes of examination, the two recitations of “first processed signal” are being interpreted as being related.
Regarding claim 6, the claim recites “the processed signal determine is configured to determine … a second processed signal …”. However, claim 1 recites “a processed signal determine configured to determine … a second processed signal …”. In light of the specification, it is currently unclear if the determined second processed signals are the same, related, or different. For the purposes of examination, the two recitations of “second processed signal” are being interpreted as being related.
Regarding claim 6, the claim recites “the fluid responsiveness parameter determine is configured to determine the responsiveness parameter (PPV) by: a’’) identifying a first fluid responsiveness parameter determination signal …”. However, claim 1 recites “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter (SPV, PPV) by: a) identifying first fluid responsiveness parameter determination signals …”. In light of the specification, it is currently unclear if “first fluid responsiveness parameter determination signal” are the same, related, or different. For the purposes of examination, the two recitations of “first fluid responsiveness parameter determination signal” are being interpreted as being related.
Regarding claim 6, the claim recites “combining them” in line 9. In light of the specification, it is currently unclear what is encompassed by “them”. For the purposes of examination, “them” is being interpreted as the identified first fluid responsiveness parameter determination signals for each of the processed signals.
Regarding claim 6, the claim recites “the fluid responsiveness parameter determine is configured to determine the responsiveness parameter (PPV) by: a’’) identifying … a second fluid responsiveness parameter determination signal”. However, claim 1 recites “a fluid responsiveness parameter determiner configured to determine the fluid responsiveness parameter (SPV, PPV) by: a) identifying … second fluid responsiveness parameter determination signals”. In light of the specification, it is currently unclear if “second fluid responsiveness parameter determination signal” are the same, related, or different. For the purposes of examination, the two recitations of “second fluid responsiveness parameter determination signal” are being interpreted as being related.
Regarding claim 6, the claim recites “combining them” in lines 11-12. In light of the specification, it is currently unclear what is encompassed by “them”. For the purposes of examination, “them” is being interpreted as the identified second fluid responsiveness parameter determination signals for each of the processed signals.
Regarding claim 8, line 4 recites “a respiratory rate provider”. However, claim 1 recites “a respiratory rate provider”. In light of the specification, it is currently unclear if the two recitations of “a respiratory rate provider” are the same, related, or different. For the purposes of examination, the two recitations are being interpreted as being the same.
Regarding claim 8, line 6 recites “a heart rate provider”. However, claim 1 recites “a heart rate provider”. In light of the specification, it is currently unclear if the two recitations of “a heart rate provider” are the same, related, or different. For the purposes of examination, the two recitations are being interpreted as being the same.
Regarding claim 8, line 8 recites “a processed signal provider”. However, claim 1 recites “a processed signal determiner”. In light of the specification, it is currently unclear if the two recitations of “a processed signal provider/determiner” are the same, related, or different. For the purposes of examination, the two recitations are being interpreted as being the same.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 9:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 9 is directed to a computer-implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 9 recite an abstract idea. In particular, the claims recite the following:
Determine a first processed signal … and a second processed signal;
Identifying first fluid responsiveness parameter determination signals based on the first and second processed signals … and identifying second fluid responsiveness parameter determination signals based on the first and second processed signals; and
Determining the fluid responsiveness parameter based on the first fluid responsiveness parameter determination signals and the second fluid responsiveness parameter determination signals.
These elements recited in claims 1 and 9 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Determining a first processed signal and a second processed signal by determining upper envelopes and lower envelopes is drawn to mathematical calculations. Further, determining a first processed signal and a second processed signal by determining upper envelopes and lower envelopes is drawn to a mentally process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view blood pulsation signals on a piece of paper and determine upper and lower envelope signals. There is nothing to suggest an undue level of complexity in the determining step.
Identifying first fluid responsiveness parameter determination signals and second fluid responsiveness parameter determination signals are drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view the first and second processed signals along with spectral range data on a piece of paper to identify the first and second fluid responsiveness parameter determination signals. There is nothing to suggest and undue level of complexity in the claimed identifying steps.
Determining the fluid responsiveness parameter based on the first and second fluid responsiveness parameter determination signals is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view the first and second fluid responsiveness parameter determination signals on a piece of paper and determine a fluid responsiveness parameter based on the signals and utilizing a look up table. There is nothing to suggest an undue level complexity in the claimed determining step.
Prong Two: Claims 1 and 9 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “processed signal determiner” (claim 1), “fluid responsiveness parameter determiner” (claim 1)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a respiratory rate provider” (claim 1), “a heart rate provider …” (claim 1), “a blood pulsation signal provider …” (claim 1), “providing a respiratory rate” (claim 9), “providing a heart rate” (claim 9), “providing a blood pulsation signal” (claim 9) - with no structure); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. N/A)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Further, “processors” and “computer-implemented …” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 9 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, with no specific structure recited, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-8 and 10-12 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“applying a filter … determine a filtered fluid responsiveness parameter determination signal …” (claim 2), “determine the fluid responsiveness parameter based on characteristic values …” (claim 3), “determine a first processed signal obtained by applying a filter … identifying a first fluid responsiveness parameter determination signal … combing the first fluid responsiveness parameter determination signals … identifying a second fluid responsiveness parameter determination signal … determining the fluid responsiveness parameter based on the combined first fluid responsiveness parameter determination signal …” (claim 4), “determine the fluid responsiveness parameter based further on the blood pressure characteristic …” (claim 5), “determine a first processed signal by applying a filter … identifying a first fluid responsiveness parameter determination signal … combing them … identifying a second fluid responsiveness parameter determination signal … coming them .. determining the fluid responsiveness parameter …” (claim 6), “determination of the first and second processed signals … involves a regularization of detected blood pulses …” (claim 7), “identifying a first reliability determination signal … identifying a second reliability determination signal … determining the reliability of the determined fluid responsiveness parameter …” (claim 8), “determine the hemodynamic parameter by applying the combined model …” (claim 8), “determine a reliability … determining the hemodynamic parameter by applying the combined model” (claim 10)),
Further describe the pre-solution activity (or the structure used for such activity) (“a blood pressure characteristic provided …” (claim 5), “a respiratory rate provider” (claim 8), “a heart rate provider” (claim 8), “a processed signal provider” (claim 8), “a second fluid responsiveness parameter determination signal provider …” (claim 8), “a reliability determiner …” (claim 8), “a first model provider …” (claim 8), “a second model provider …” (claim 8), “a combined model determiner …” (claim 8), “a hemodynamic parameter determiner …” (claim 8) - with no specific structure claimed),
Further describe the computer implementation (“non-transitory computer-readable medium …” (claim 11 and claim 12)), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Further, “a processor” and “non-transitory computer-readable medium” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-12 are rejected.
Prior Art Analysis
Claims 1-12 are not rejected in view of prior art. The closest prior art made of record includes: Acosta et al. (US 20200260969 A1), hereinafter referred to as Acosta, Kim et al. (US 20110077532 A1), hereinafter referred to as Kim, and Stephan Joeken (US 20080033306 A1), hereinafter referred to as Joeken.
Acosta teaches a system for determining a fluid responsiveness parameter for a patient, wherein the determined fluid responsiveness parameter is a systolic pressure variation (SPV) or a pulse pressure variation (PPV) (Abstract, Fig. 12, para. [0003]), wherein the system comprises: a respiratory rate provider configured to provide a respiratory rate (Fig. 12, element 1210, para. [0029]), a heart rate provider configured to provide a heart rate (Fig. 12, element 1210, para. [0029]), a blood pulsation signal provider configured to provide a blood pulsation signal, wherein the blood pulsation signal is a measured signal indicative of a series of blood pulses of the patient (Fig. 1, Fig. 12, element 1210, para. [0066]), and determining the fluid responsiveness parameter utilizing spectral ranges of the respiration rate and the heart rate (Fig. 2, para. [0030-0034]).
Kim teaches a system for determining a fluid responsiveness parameter for a patient, wherein the determined fluid responsiveness parameter is a systolic pressure variation (SPV) or a pulse pressure variation (PPV) (Abstract, Fig. 1, para. [0007]), wherein the system comprises: a blood pulsation signal provider configured to provide a blood pulsation signal, wherein the blood pulsation signal is a measured signal indicative of a series of blood pulses of the patient (Fig. 1, element 104, para. [0019]), a processed signal determiner configured to determine a first processed signal based on the blood pulsation signal, wherein the first processed signal is indicative of an upper envelope of the blood pulsation signal, and a second processed signal based on the blood pulsation signal, wherein the second processed signal is indicative of a lower envelope of the blood pulsation signal (Fig. 2, para. [0029]), and determining the fluid responsiveness parameter (para. [0056]).
Joeken teaches a system for determining a fluid responsiveness parameter for a patient (Abstract, para. [0016]), wherein the system comprises: a blood pulsation signal provider configured to provide a blood pulsation signal, wherein the blood pulsation signal is a measured signal indicative of a series blood pulses of the patient (Fig. 2, para. [0058]). Joeken teaches respiratory rate and higher harmonics and heart rate and higher harmonics can be separated out to accurately determine parameters (para. [0017]).
Individually, determining upper and lower envelope signals of a blood pulsation signal, and determining and utilizing spectral ranges of the respiratory rate and the heart rate are known within the art. However, the prior art made of record does not disclose, teach, or reasonably suggest, “a) identifying first fluid responsiveness parameter determination signals (baseline_up, baseline_down) based on the first and second processed signals (env_up, env_down), wherein the first fluid responsiveness parameter determination signals correspond to the first and second processed signals (env_up, env_down) in a spectral range up to the respiratory rate, and identifying second fluid responsiveness parameter determination signals (ripple_up, ripple_down) based on the first and second processed signals (env_up, env_down), wherein the second fluid responsiveness parameter determination signals (ripple_up, ripple_down) correspond to the first and second processed signals (env_up, env_down) at the respiratory rate and any of its harmonics up to the heart rate, and b) determining the fluid responsiveness parameter (SPV, PPV) based on the first fluid responsiveness parameter determination signals (baseline_up, baseline_down) and the second fluid responsiveness parameter determination signals (ripple_up, ripple_down)”.
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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