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 Status
Claims 1-32 are pending.
Claims 1-32 are rejected.
Claims 1, 3, 6-8, 12-13, 15-27, and 29-30 are objected to.
Claims 1-32 are amended.
Claims 1 and 30 are independent.
No claims are canceled, new, or withdrawn.
Office Action Outline
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
X
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
X
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 07/12/2022 filing receipt, this application is a 371 of PCT/EP2020/073826, filed 08/26/2020. This application claims priority to foreign application DE10 2019 006 866.1, filed 10/02/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 04/01/2022.
Objection to the Specification: Title
The title should be amended to more specifically reflect the claims, particularly referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example some version of terms such as follows might be added to the title: training phase, use phase and sensor. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Reference to Claims and Specification
Reference to the Claims in this Office action is either:
(a) by plain claim number (e.g., claim 1), or
(b) by claim number and line number, where claim and line numbers are separated by a colon (e.g., claim 1:9-12 refers to claim 1 lines 9-12).
Reference to the Specification in this Office action refers to US Patent Publication
US 2022/0330837 A1, published 10/20/2022.
Claim Objections
Claims 1, 3, 6-8, 12-13, 15-27, and 29-30 are objected to because of the following informalities:
Claim 1:3 recites "...with the use of a signal" which should be corrected to "...with [[the]] use of a signal." While it is clear how the recitation is interpreted, nonetheless there is no antecedent basis for "the use." Deleting "the" would resolve this objection.
There are three steps recited beginning at claim 1:78 which are detailed at claim 1:82-99. Indentation and a colon appear to indicate a hierarchy among these steps and additionally recited subordinate steps at 1:92 and 1:95. It would improve readability to number the steps explicitly. Claim 1 may be amended to include letters or numbers at the beginning of these steps at claim 1:82, 85, 88, 92 and 95.
Claim 30 is objected to similarly, with three steps instantiated at claim 30:75, and detailed at claim 30:78-96, in which the beginning of the three described steps at claim 30:78, 81, and 84 may be amended to include letters or numbers.
Claim 1:96 recites "the compensation is performed by" which should be grammatically corrected to "the compensation [[is]] performed by."
Claim 15:8 recites "an difference" which should be grammatically corrected to "a difference."
Claim 18:8-9 recites "located at a distance from the heart - without using the measured values." For proper grammar, the dash between "heart" and "without" should be deleted.
Claim 19:17 recites "generates a second sum signal depending one measured values" which should be grammatically corrected to "generates a second sum signal depending on[[e]] measured values."
The end of claim 23:15 recites a comma that should be deleted.
Claim 30:38 recites "and to calculate" which should be corrected to "and [[to]]calculate."
A comma should be put after each of the following elements:
(a) "for at least one shape parameter" of claim 1:29
(b) "on measured values of the sun signal sensor device" of claim 1:93
(c) "channel parameter" of claim 3:14
(d) "is lower than or equal to" of claim 3:16
(e) "is greater than or equal to" of claim 3:17
(f) "to the sum signal sensor device" of claim 8:10
(g) "ventilator is in a fluid connection with the patient" of claim 12:6
(h) "located at a distance from the heart" of claim 17:14
(i) "signal sensor" of claim 19:16
(j) "the second sum signal" of claim 19:21
(k) "sample" of claim 19:24
(l) "second signal estimating unit" of claim 19:29
(m) "the first parameter value" of claim 20:27
(n) "signal estimating unit" of claim 21:22
(o) "cardiogenic signal component" of claim 22:10
(p) "range" of claim 22:15
(q) "by the breathing/ventilation" of claim 23:12
(r) "shape parameter" of claim 24:7
(s) "signal estimating unit" of claim 24:10
(t) "time period phase" of claim 25:24
(u) "ventilator" of claim 29:4
(v) "by the ventilator" of claim 29:13
(w) "by an additional sensor" of claim 30:35
A colon should be put after each of the following elements:
(a) "the steps performed by the signal processing unit of " of claim 3:11
(b) "performed by the signal processing unit of " of claim 6:5
(c) "processing unit of " of claim 7:5
(d) "steps that the signal processing unit" of claim 8:4
(e) "steps that the signal processing unit" of claim 8:19
(f) "the breathing state sensor measures at least one of" of claim 12:2
(g) "the signal processing unit" of claim 13:11
(h) "processing unit" of claim 13:22
(i) "the signal processing unit" of claim 16:8
(j) "wherein the signal processing unit" of claim 17:11
(k) "the signal processing unit" of claim 18:6
(l) "processing unit receives" of claim 19:6
(m) "signal processing unit" of claim 19:14
(n) "signal processing unit" of claim 19:26
(o) "signal processing unit" of claim 20:4
(p) "signal processing unit" of claim 20:11
(q) "processing unit" of claim 20:21
(r) "unit carries out the steps of" of claim 21:4
(s) "the steps of" of claim 21:20
(t) "of the signal processing unit" of claim 22:4
(u) "furthermore takes the action of" of claim 22:12
(v) "signal processing unit" of claim 23:6
(w) "signal processing unit" of claim 24:8
(x) "processing unit" of claim 25:19
(y) "signal processing unit" of claim 26:9
(z) "signal processing unit" of claim 27:3
(aa) "steps in the use phase of" of claim 29:6
(bb) "is configured to" of claim 30:18
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Instant claim limitations interpreted as PROPERLY invoking 112(f)
The following claim limitation are interpreted as invoking 112(f):
• A "sum signal sensor device" recited in claim 1 and "sum sensor device" in claim 30 recites means and function (an equivalent, nonce term, here a "sensor device", and function of sensing, here "measures a signal generated in the body") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at [0069, 0075, 0076], and as such, is definite under 112/b as properly invoking 112/f. MPEP 2181.III-IV pertain.
• A "body geometry sensor" recited in claim 10 and 11 recites means and function (in a "sensor") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at [0079-0080], and as such, is definite under 112/b as properly invoking 112/f. MPEP 2181.III-IV pertain.
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.
Instant claim limitations interpreted as NOT invoking 112(f)
The following limitations are interpreted as not invoking 112(f):
• A "signal processing unit configured to carry out, ...receive, ...generate, ...detect" recited in claim 30, and the "signal processing unit" recited in claims 1-8, 10, 13-14, 16-27, 29, and 31-32, recites means (or an equivalent, nonce term, here a "unit") and function and/or result (here "carry out, ...receive, ...generate, ...detect"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure not to invoke. MPEP 2181.I.C pertains.
• A "signal estimating unit" recited in claims 1-3, 8, 13, 16, 19-21, 24-27, and 30, recites means (or an equivalent, nonce term, here a "unit") and function and/or result (here "yield a shape parameter", "calculating a shape parameter value," determining first transmission channel parameter values and value ranges, etc.), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (here for receiving, processing, generating values, etc.) not to invoke. MPEP 2181.I.C pertains.
• At least one "first sum signal sensor" and at least one "second sum signal sensor" recited in claim 19 recites means and function (in a "sensor") but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (here, in measuring signals generated in the body of a patient) not to invoke. MPEP 2181.I.C pertains.
• A "breathing state sensor" recited in claim 11 and 12 recites means and function (in a "sensor") but the recitation does not invoke 112/f because the claims are interpreted as reciting sufficient structure (in this instance in the form of measuring current breathing state and/or ventilating state (claim 11); flow of gas into or out of the body, airway pressure (claim 12) ) not to invoke. MPEP 2181.I.C pertains.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-32 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. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
In independent claim 1, "measured values" is first recited at claim 1:10. It is not clear if the "measured values" recited at claim 1:14, 1:64; and 1:93 are the same as "measured values" at claim 1:10.
Similarly, in independent claim 30, "measured values" is first recited at claim 30:9. It is not clear if the "measured values" recited at claim 30:12, 30:14; and 30:37 are the same as "measured values" at claim 30:9.
Additionally, the term "measured values" is repeated in the dependent claims, as follows: In claim 10 (twice), claim 13 (four times), claim 17 (twice), claim 18 (twice), claim 19 (four times), claim 20 (twice), claim 22 (once), claim 31 (once), claim 32 (once). It is not clear which "measured values" are being referred to in each instance of "measured values" in the dependent claims.
In the recitation "detecting during the training phase, with the signal processing unit, a plurality of heartbeats" at claim 1:18-19, it is unclear in what way a signal processing unit, which is interpreted as software, would detect heartbeats. Possibly amending "the signal processing unit" to a sum signal sensor device might help to overcome the rejection.
It is unclear which unit is being referred to in the recitation "which unit" at the end of claim 1:50. The "unit" in "which unit" could refer to "the signal processing unit" of claim 1:49, or to "the signal estimating unit" of claim 1:50. Claim 30:49 is rejected for the same issue.
In the instant claims, the term "[[in]]to" is recited at claims 1:83, 1:86, 2:14, 6:4, 30:79, and 30:82. The use of the term "to" by itself is confusing because elements are being "combined...to," leading to a lack of clarity over what is being combined and what the outcome of the combination is. Possibly amending all instances of "[[in]]to" to recite "[[in]]to determine" may help to overcome this rejection.
In claim 8:21-24, there are grammatical problems in the recitation "which measured or calculated values the first transmission channel parameter and the additional transmission channel parameter, respectively, assume at the heartbeat" such that the claim is unclear and cannot be interpreted appropriately.
In claim 13:25 and 13:30 , the connection is unclear between "the current relative position" (at claim 13:25) and "the calculated relative position" (at claim 13:30). It is not clear if "the current relative position" and "the calculated relative position" are referring to the same relative position or not.
In claim 24:16, the origin is unclear of the term "said segment" in the recitation "which said segment." It is not known if the "said segment" refers to an "estimated signal segment" or to "the segment of the sum signal."
In claim 28:5-6 the connection is unclear between the triggering of the ventilation strokes and the determined estimated respiratory signal in the recitation "wherein the ventilation strokes are triggered depending on the determined estimated respiratory signal." This is because there is an embodiment of claim 1, from which claim 28 depends, that does not include the determination of the estimated respiratory signal (see claim 1:78-99). Possibly amending claim 28 to include an active step of determining the estimated respiratory signal might help to overcome this rejection.
In a similar rejection, in claim 29:9, the connection is unclear between the ventilator signal and the estimated respiratory signal in the recitation "comparing the ventilator signal with the estimated respiratory signal." Further, the assessment at claim 29:11-14, and ultimately causing the ventilator operating parameter to change and/or causing an alarm to sound, depends on the comparison of ventilator signal and the estimated respiratory signal. Because there is an embodiment of claim 1, from which claim 29 depends, that does not include the determination of the estimated respiratory signal (see claim 1:78-99), then claim 29 presents a lack of clarity for this issue. Possibly amending claim 29 to include an active step of determining the estimated respiratory signal might help to overcome this rejection.
The word "signal" appears to have been omitted in the terms "a sum sensor device" and "sum sensor device," which are respectively recited at claim 30:9 and at claim 30:10. Later in claim 30, at claim 30:14-15, the term "the sum signal sensor device" lacks clear antecedent basis. Possibly amending to recite "a sum signal sensor device" at claim 30:9 and "the sum sensor signal device" at claim 30:10 will overcome the rejection.
In claim 30, related to but distinct from the below 101 rejections, each instance of "configured to," e.g. each instance of "...unit is configured to...," renders the claim indefinite due to a lack of clear structure corresponding to the recited "configured to." Claim 30 is to a 101 machine or manufacture, in this instance a "signal processing unit," and such claims, in contrast to 101 process claims, are interpreted strictly according to their recited structure. Thus, for recitations of process steps, such as "carrying out a training phase," to be clearly interpreted and limiting, they must correspond to structure comprised by the claimed "signal processing unit." In the present claims, it is not clear what structure corresponds to the recited instances of "configured to" and the associated process steps. This rejection might be overcome, for example, by amending to recite a storage device comprising stored instructions, the stored instructions configured according to the recited "units," process steps and their associated limitations. Then it would be clear that the claimed "signal processing unit" comprises structure corresponding to and allowing clear interpretation of the recited units and associated functions.
Claim 30:72 is unclear in reciting "respectively in the course of the," as no appropriate term follows "of the." Possibly amending to "respectively in the course of the heartbeat" might help to overcome this rejection.
Claim 30:91 is unclear in reciting "during the use phase as well and." The recitation cannot be interpreted due to lack of clarity.
In claim 31 depending from claim 1, it is unclear which of the process steps of claim 1 are required to be performed, at least because in (i) one instance the claim recites "A process according to claim 1...," interpreted as the entirety of claim 1, but (ii) in a later instance the claims recites "...an execution of the program causes, during... when..., the signal processing unit to carry out at least some of the process steps," interpreted as at least one or two or more of the steps of claim 1. Also, interpretation of "some" as to "one or more" or "two or more" is unclear. In (i), all claim 1 steps are required. In (ii), possibly all claims 1 steps are required to be performed by the claim, but only a subset must be executed by the signal processing unit. Interpretation is further ambiguous due to at least two recited conditionals: "during..." and "when..." Generally, it is unclear what the claim requires. Claim 32 is rejected similarly.
Lack of Antecedent Basis:
The following recitations require but lack clear antecedent basis (bold emphasis added):
(a) Claim 1:37, both elements in "the value of the first transmission channel parameter."
(b) Claim 6:8, "the same sequence of relative sampling time points."
(c) Claim 8:20, "the respective measured value."
(d) Claim 13:9, both elements in "the position sensor measures the relative position."
(e) Claim 13:28, "the estimated signal segment."
(f) Claim 14:4, "the received sum signal." It is noted that the sum signal is not received, but generated in claim 1:13-15. Claim 14 depends from claim 1. Possibly amending claims 14:4 from "the received sum signal" to "the generated sum signal" would help in overcoming this lack of antecedent basis rejection.
(g) Claim 16:20, "the estimated signal segment."
(h) Claim 16:24, "the standard reference segment." Possibly amending to "the standard reference signal segment" would help in overcoming this lack of antecedent basis rejection.
(i) Claim 16:31, "the adapted standard reference signal segment." Possibly amending to "the adapted predefined standard reference signal segment" would help in overcoming this lack of antecedent basis rejection.
(j) Claim 19:3, "the sensor signal device". Possibly amending to "the sum signal sensor device" would help in overcoming this lack of antecedent basis rejection.
Regarding each lack of antecedent basis rejection (a) - (i) above: If the recitation refers to a previously instantiated instance, then it is not clear which instance that is. If the recitation instantiates the claim element, then this is not clear. The rejections might be overcome by for example amending to recite the article "a" instead of "the" or an equivalent amendment. For compact examination, it is assumed that the preceding suggestion will be implemented.
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 belonging to no clear statutory category – Claim 30:
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is not clearly directed to statutory subject matter.
Independent claim 30 is directed to a "signal processing unit." A " signal processing unit" is not, in all embodiments within a BRI, interpreted as belonging to any category listed in 101. In a BRI, claim 30 read on data and/or software comprising no structure other than data and/or software. None of the recited "signal processing unit," other "unit[s]," recitations of "configured to," etc. require that the claimed invention comprise at least one non-transitory element. Claim 30 reads on transitory propagating signals which is not proper patentable subject matter because it does not fit within any of the four 101 statutory categories of invention (In re Nuijten, Federal. Circuit, 2006).
As appropriate, this rejection can be overcome by, for example, amending claim 30 to recite at least one non-transitory, physical element, e.g. a storage device comprising stored instructions (claim 30).
Claims directed to judicial exceptions - Claims 1-32:
Claims 1-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
laws of nature and natural phenomena are naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1 Analysis:
Step 1: NO, regarding claim 30, as discussed in the preceding 101 rejection; however, for compact examination, claim 30 will be examined with the expectation that Applicant will amend claim 30 to include one non-transitory, physical element, e.g. a storage device comprising stored instructions as discussed above.
Step 1: YES, regarding claims 1-29 and 31-32: Claim 1 recites a 101 process, while claim 31 recites a 101 process, here a "process according to claim 1" comprising process steps such as "receiving..." (recited in claim 1) and "is provided" (recited in claim 31). Therefore claims 1-29 and 31-32 are directed to 101 processes; which fall under the categories of statutory subject matter. (See MPEP § 2106.03).
Step 2A, Prong One Analysis:
The claims recite judicial exceptions in the form of abstract ideas as follows:
Independent claim 1 recites a process for performing mental processes and mathematical concepts for:
(a) calculating:
• an estimate for a cardiogenic signal and/or a respiratory signal (claim 1:1)
• the value of the first transmission channel parameter (claim 1:36-37)
• shape parameters (claim 1:68)
• an estimated cardiogenic signal segment and/or a respiratory signal segment (claim 1:72)
(b) detecting:
• heartbeat time or heartbeat time period of the heartbeat (claim 1:59-60)
(c) determining:
• a sum signal segment (claim 1:26)
• a shape parameter value for a shape parameter (claim 1:29-30)
• estimated respiratory signal or cardiogenic signals (claim 1:89)
(d) generating:
• a sum signal (claim 1:13-15)
• a sample and sample elements (claim 1:21-22)
• the sample element for the heartbeat (claim 1:44-45)
• a signal estimating unit (claim 1:49-50)
(e) combining signal segments (claim 1:82 and 85)
(f) compensating the influence of heartbeat on sum signal (claim 1:95)
Independent claim 30 recites similar mental processes and mathematical concepts as independent claim 1.
Dependent claims 2-29, and 31-32 further limit the abstract ideas recited in independent claim 1.
Product by Process Interpretations:
The recited claim 1 and 30 term "measured values" is interpreted as a product-by-process element, i.e. the recited "values" are limited according to any structure clearly required by the recited product-by-process limitation of having been "measured." The recited process or step of having been "measured" is not itself claimed and is limiting only to the extent that the structure of the "values" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential). As claims 10, 13, 17-20, 22, and 31-32 each recites "measured values" and ultimately depend from claim 1, this interpretation applies to the "measured values" in claim 10, 13, 17-20, 22, and 31-32 as well. Possibly reciting an active step of measuring in the claims may result in withdrawal of the product-by-process interpretation.
The recited claim 10 "values have been measured" is interpreted as a product-by-process element, i.e. the recited "values" limited according to any structure clearly required by the recited product-by-process limitation of having been "measured." The recited process or step of having been "measured" is not itself claimed and is limiting only to the extent that the structure of the "values" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
Step 2A Prong One Summary: The claims recite abstract ideas, characterized as mental processes and mathematical concepts. Considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claims 1 and 30 (e.g., in the steps for calculating, detecting, determining, combining, compensating, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, because there are no limitations recited which would prevent the analysis and generating of results mentally. Additionally, the limitations of calculating shape parameters, estimates of cardiogenic/respiratory activity, and values of transmission channel parameters, etc., inherently recite mathematical concepts, such as those described throughout the Specification, and at [0148-0149, 0156-0166, 0177, 0195], etc. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute judicial exceptions in the form of abstract ideas. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two Analysis:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Claims 1, 4, 8, 10, 13, 19-21, and 29-32 recite additional elements of receiving data or detecting data from a sensor. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps, generally and unless persuasively demonstrated to the contrary, are considered insignificant extra-solution activity, and are insufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed [see MPEP § 2106.04(d)(I)].
Additional element of therapy (mechanical ventilation): Claims 28 and 29 both recite additional elements in limitations for therapy involving mechanical ventilation in which the product of the judicial exception (JE), i.e., the determined estimated respiratory signal, informs the additional element of mechanical ventilation of a patient on a ventilator. However, there is an embodiment (of the combinations of at least one of the three alternatives at claim 1:78-99) in which only the estimated cardiogenic signal is determined while the estimated respiratory signal is not determined. This would occur when carrying out only the alternative of combining cardiogenic signal segments to (determine) the estimated cardiogenic signal (at claim 1:82-83). Because of the embodiment in which the estimated respiratory signal is not determined, claims 28 and 29 do not yet recite a practical application of a particular therapy informed by the judicial exception at Step 2A Prong Two. If claims 28 and 29 were amended to recite the determination of an estimated respiratory signal, then claims 28 and 29 might possibly recite a practical application of a particular therapy indicating patent-eligible subject matter under 35 U.S.C. 101, corresponding to the second listed consideration above.
Additional elements of computers, sensors, and ventilators: Claim 1 recites the additional element of a computer ("computer-implemented process") and a signal processing unit; claim 31 recites the additional element of a computer program; claims 1, 8-14, 17-20, 22, 25, and 30-32 recite the additional element of a sensor; claims 12 and 28-29 recite the additional element of a ventilator. The claims require only generic computer components, sensors, and ventilators. It is not yet clear that any one or combination of these elements improve computer technology, sensor technology, ventilator technology or other technology, nor that any integrate the recited judicial exceptions into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement. It is noted Specification [0018] discloses a basic object of the present invention is to provide a process and a signal processing unit, which determine an estimate or representation for a cardiogenic signal and/or for a respiratory signal from a sum signal...better than do prior-art processes and signal processing units, however, this is not yet enough to show an improvement. (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the judicial exceptions (i.e., the abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of receiving data from a sensor of claims 1, 4, 8, 10, 13, 19-21, and 29-32 do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity. Additionally, the following reference shows receiving data from sensors to be well-understood, routine, and conventional:
Charlton, (IEEE reviews in biomedical engineering, vol. 11, pp.2-20 (2017); cited on the attached form PTO-892), shows sensor data (p.3-6).
Therefore the additional elements of data gathering and outputting do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional element of therapy (mechanical ventilation): The additional element of mechanical ventilation of claims 28 and 29 does not cause the claim to rise to the level of significantly more than the judicial exception, as the additional elements of ventilators are shown to be routine and conventional in the art as follows:
Helfenbein, (Journal of electrocardiology, vol.47(6), pp.819-825 (2014; cited on the attached form PTO-892), shows ventilation and ventilators (p.823-825).
Therefore the additional elements of therapy (mechanical ventilation) do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computers, sensors, and ventilators: Claim 1 recites the additional element of a computer and a signal processing unit; claim 31 recites the additional element of a computer program; claims 1, 8-14, 17-20, 22, 25, and 30-32 recite the additional element of a sensor; claims 12 and 28-29 recite the additional element of a ventilator. These additional elements do not cause the claims to rise to the level of significantly more than the judicial exception; these are conventional computer components, sensors, and ventilators, and therefore, the additional elements of conventional computer components, sensors, and ventilators do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept. Additionally, the following reference shows the sensors and ventilators to be well-understood, routine, and conventional:
Charlton, (IEEE reviews in biomedical engineering, vol. 11, pp.2-20 (2017); cited on the attached form PTO-892), shows sensors (p.3; p.11).
Helfenbein, (Journal of electrocardiology, vol.47(6), pp.819-825 (2014; cited on the attached form PTO-892), shows ventilators (p.823-825).
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claim 1 and 30, which recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited computers and sensors are used in obtaining and analyzing data; as such, the computers and sensors act only as tools to perform the steps of data analysis and data obtaining, and do not integrate the exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The computers and sensors of the claims used in data analysis and obtaining data do not impose meaningful limitations on the claims.
• The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The acquiring, obtaining, and transmitting of data in claims 1 and 9 is recited in a generic manner.
Step 2B Summary: All limitations of claims 1-32 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.)
Therefore, claims 1-32, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
35 USC § 102 and 103
Regarding claims 1-32, with respect to prior art, a search was performed and no prior art was found that teaches or suggests at least the particular combination of the claimed process for generating sample elements, generating signal estimating units, and calculating transmission channel parameters in determining estimates for cardiogenic and respiratory signals. Close art includes Derks, (US Patent 11,083,404 B2, 08/10/2021; cited on the attached form PTO-892), and Kahl, (US Patent 11,779,283 B2, 10/10/2023; cited on the attached form PTO-892). Subject to resolution of the above 112(b) rejections, it is assumed that claims 31-32 each require that all of the claim 1 process steps be performed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
NSDP-1of 2:
Claims 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of reference U.S. Patent No.11,779,283 (from application 17/242,663). Although the claims at issue are not identical, they are not patentably distinct from each other because reference patent '283 recites process and unit claims which involve similar limitations as the instant claims, e.g., for receiving measured values, generating a sum signal comprising a superimposition of cardiac activity and breathing or ventilation activity of a patient, detecting heartbeats, and determining an estimate for cardiogenic signal and/or respiratory signal.
NSDP-2 of 2:
Claims 1-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over one or more claims of reference Application Nos. 17/707,476, 18/365,281, and 19/179,209. Although the claims at issue are not identical, they are not patentably distinct from each other because reference applications 17/707,476, 18/365,281, and 19/179,209 each recite process and unit claims which involve similar limitations as the instant claims, e.g., for receiving measured values, generating a sum signal comprising a superimposition of cardiac activity and breathing or ventilation activity of a patient, detecting heartbeats, and determining an estimate for cardiogenic signal and/or respiratory signal.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686