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 .
Drawings
The drawings are objected to because in fig. 1, there are a plurality of structures, however, some form of connection such as a bracket or connecting axis is missing, if the reference numerals 14/24/34, 44, and 2 are not part of the same assembly, then each view should be in a separate figure. If they are part of the same assembly, some form of connection is required. See 37 CFR 1.83(h)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the limitations “at least one respiration unit for generating an airflow for respiration” (claim 1, lines 1-2, the term “unit” is a generic placeholder and the function is “for generating an airflow for respiration”) and “at least one monitoring unit for detecting at least one respiration parameter and for classifying events in respiration on the basis of monitoring the at least one respiration parameter” (claim 1, lines 2-4, the term “unit” is a generic placeholder and the function is “monitoring” and “for detecting at least one respiration parameter and for classifying events in respiration on the basis of monitoring the at least one respiration parameter”).
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.
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:
“at least one respiration unit”: a respiration unit 2, which is enclosed by a housing 101, having a fan unit 3 for generating an airflow for respiration, see page 14 of the specification filed on 7/03/2024.
“at least one monitoring unit”: monitoring unit 5 comprising a controller 25, storage unit 15, and a sensor unit 35, see pages 14-15 of the specification filed on 7/03/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 claims “at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS respiration” (lines 9-13) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification and drawing fail to disclose any specifics on what is the algorithm that is used to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS respiration. See MPEP 2161.01 (I), which states “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV… When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2162- § 2163.07(b). If the specification does not provide a disclosure of sufficient corresponding structure, materials, or acts that perform the entire claimed function of a means- (or step-) plus- function limitation in a claim under 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C. 112, "the applicant has in effect failed to particularly point out and distinctly claim the invention" as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA 35 U.S.C. 112 ]. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection. See also MPEP § 2181, subsection II.B.2(a).” In the instant application, the specification merely mentions the word “algorithm”, but provides no details regarding what the algorithm is or how the algorithm is performed, therefore, there is a lack of written description on the algorithm.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 3-7 and 17-20 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 pre-AIA the applicant regards as the invention.
Regarding claim 3, the limitation “the event analysis” (lines 2-3) lacks proper antecedent basis. It is unclear as to what the event analysis is referring to, is the event analysis a new event analysis or is “the event analysis” referring to “analyze the at least one flow signal and/or at least one pressure signal” (claim 1, lines 8-9).
Any remaining claims are rejected for their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meier (2006/0249149).
Regarding claim 1, Meier discloses a respiration device (see device in fig. 3, paragraph 0117), wherein the device comprises at least one respiration unit (34, fig. 3, paragraph 0167) for generating an airflow for respiration and at least one monitoring unit (associated controller 40 and pressure module 37 and pressure sensor, see fig. 3, paragraphs 0169 and 0199, alternatively, Meier discloses that the CPAP device would have flow and pressure measuring device for measuring flow and pressures) for 5detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor pressure signal from at least one associated sensor unit (pressure module 37, paragraphs 0023 and 0169) to detect the one pressure property of an airflow for 10the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS 15respiration (paragraph 0036, Meier discloses that apnea phase is to be classified as central or obstructive, which is considered as first class comprising events which are relevant for CS (Cheyne-Stokes), Meier discloses in paragraph 0037 that the invention evaluation features are generated for phase with Cheyne-stokes respiration and snoring phase, therefore, the classification of central apnea and obstructive apnea would be relevant for CS respiration, Meier further discloses in paragraph 0080 that snoring is classified, wherein snoring can be considered as not being relevant for Cheyne-stokes per claim 2 of the instant application).
Regarding claim 2, Meier discloses that the events of the second class comprises snoring (see paragraph 0080 and the rejection to claim 1).
Regarding claim 3, Meier discloses that the monitoring unit is configured to sort the events of the first class into at least two validity classes for the vent analysis, comprising a first validity class comprising events which typically cover in a case of CS respiration and a second validity class comprising events which typically do not occur in cases of CS respiration (see paragraph 0036, Meier discloses that the first class include apnea phases and that the evaluation features include information includes whether the apnea phase is to be classified as central apnea or obstruction apnea, each is a validity class since it is utilized as evaluation features, wherein the central apnea is a first validity class and the obstructive apnea is a second validity class, furthermore, the events are the same as claimed therefore the central apnea would comprise an event that is typically occur in a case of CS respiration and the obstructive apnea would be a validity class comprising events which are typically do not occur in a case of CS respiration).
Regarding claim 4, Meier discloses that events of the first validity class comprises events of central apnea (see paragraph 0036 and the rejection to claim 3 above).
Regarding claim 5, Meier discloses that the events of the second validity class comprises events of an obstructive apnea (see paragraph 0036 and the rejection to claim 3 above).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 11 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Meier (2006/0249149).
Regarding claim 1, Armitstead discloses a respiration device (device shown in fig. 9 and figs. 1-3), wherein the device comprises at least one respiration unit for generating an airflow for respiration (the at least one respiration unit is the flow generator, see paragraph 0036) and at least one monitoring unit (the flow sensor shown in fig. 9 and paragraph 0043, and the controller 904/CSR detector 100, see paragraphs 0045 and 0114) for 5detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal from at least one associated sensor unit (the flow sensor shown in fig. 9 and paragraph 0043) to detect at least one flow property of an airflow (paragraph 0043, Armitstead discloses flow sensor for capturing air flow) for 10the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event and sort events into classes comprising at least one first class comprising events which are relevant for CS (see paragraphs 0050, 0052-0056, 0062, and 0103-0104, Armitstead discloses that the Cheyne-Stokes detection module 108 classifies a period of Cheyne-Stokes respiration by analyzing clusters of apneas and hypopneas, furthermore, Armitstead discloses there are three useful raw features, first is the cycle length, second useful raw feature is the shape feature, and third useful feature is the duty cycle, and for each raw features are classified, the raw features being classified are used to determined CS therefore they are relevant to CS, Armitstead further discloses in paragraph 0041 that cycle length of apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, therefore, by indicating what is an apnea or hypopnea, the device would have to classify the captured flow pattern as such, paragraph 0051, Armitstead discloses that the Cheyne-Stokes detection module would calculate three raw features including a cycle length histogram for cluster of apneas and hypopneas, alternatively, Armitstead discloses in paragraph 0071 that the jump feature can be used to distinguish between obstructive apneas/hypopneas class and central apneas/hypopneas, therefore, the first class is the central apneas/hypopneas and the obstructive apneas/hypopneas class), but fails to disclose sorting into two classes comprising at least one second class comprising events which are irrelevant for CS 15respiration.
However, Meier teaches a respiration device (entire device shown in fig. 3) comprising a monitoring unit (pressure sensor and associated controller, see paragraph 0199) for classifying an event that is irrelevant for CS respiration (see paragraphs 0059, 0064 and 0080, see classification of snoring).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respiration device of Armitstead to classify and sort an event which irrelevant for CS respiration as taught by Meier for the purpose of providing a snoring index so that the snoring can be evaluated such that the respiratory gas pressure can be set (see paragraphs 0064, 0080 and 0207 of Meier).
Regarding claim 2, the modified Armitstead discloses that the events of the second class comprises snoring (see paragraphs 0059, 0064 and 0080 of Meier).
Regarding claim 3, the modified Armitstead discloses that the monitoring unit is configured to sort the events of the first class into at least two validity classes for the event analysis, comprising a first validity class comprising events which typically occur in a case of CS respiration and a second validity class comprising events which typically do not occur in a case of CS respiration (Armitstead discloses in paragraph 0041 that cycle length of apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, therefore, by indicating what is an apnea or hypopnea, the device would have to classify the captured flow pattern as such, wherein the first validity class is apnea and the second validity class is hypopnea, paragraph 0051, Armitstead discloses that the Cheyne-Stokes detection module would calculate three raw features including a cycle length histogram for cluster of apneas and hypopneas, wherein the classification of apneas would be first validity class and the hypopnea would be a second validity class, alternatively, Armitstead discloses in paragraph 0071 that the jump feature can be used to distinguish between obstructive apneas/hypopneas and central apneas/hypopneas, therefore, the first validity is the central apneas/hypopneas and the second validity is the obstructive apneas/hypopneas).
Regarding claim 4, the modified Armitstead discloses that the events of the first validity comprises central apnea (see alternative interpretation in claim 3, Armitstead discloses a first validity comprises central apneas).
Regarding claim 5, the modified Armitstead discloses that the events of the second validity comprises obstructive apneas (see alternative interpretation in claim 3, Armitstead discloses a second validity class including obstructive apnea).
Regarding claim 6, the modified Armitstead discloses that the monitoring unit is configured to register the presence of CS respiration when at least three events occur in chronological succession and in this case at least two of the at least three events correspond to the first validity and at most one event of the at least three events corresponds to the second validity class. See paragraphs 0010, Armitstead discloses that cycle length histogram may be generated based on events and CS respiration may be detected based on the generated cycle length histogram. Further stated in paragraph 0059 that the cycle length histogram gathers the cycle length data for a cluster of apneas and hypopneas during the CSR period, based on its length, associates each cycle with one of a plurality of bins, and each bins can be spaced 10 seconds apart up to 105, therefore, there are more than 3 or 4 events being monitored, wherein each event is considered as a bin. Armitstead further discloses in paragraph 0083 that during CSR period, it would be expected that the average cycle length would be between 40 to 90 seconds, thus, in one example the region of interest may be defined as the bins, which cover cycle lengths between 40 and 90 seconds. When the patient experience two apneas and one hypopneas within time frame of 40-90 seconds, the apnea would be considered as the first validity class and the hypopnea would be considered as the second validity class.
Regarding claim 7, the modified Armitstead discloses that at least four events are analyzed (see paragraphs 0059 and 0083 of Armitstead, Armitstead discloses that each apnea or hypopnea event is classified as a bin, and each bin can be arranged as 10 seconds apart up to 110 seconds, however, 40 seconds to 90 seconds to determine a CSR period, therefore, at least 4 events would be analyzed).
Regarding claim 8, the modified Armitstead discloses that the device is configured to output a corresponding notification to a user in the event of a register CS respiration (see paragraph 0113 of Armitstead, Armitstead discloses a display interface 810 to output CSR detection reports, paragraphs 0010 and 0012 of Armitstead discloses that the apparatus is for indicating a presence of Cheyne-Stokes respiration, paragraph 0107 of Armitstead discloses panel 760 displays notification that a CSR has been positively detected).
Regarding claim 9, the modified Armitstead discloses that the device is configured, in the event of a registered CS respiration, to set the respiration unit to at least one respiration mode for respiration in a case of CS respiration (see paragraph 0116 of Armitstead, Armitstead discloses that the therapeutic pressure levels may be automatically adjusted in response to the detection of CSR conditions).
Regarding claim 11, the modified Armitstead discloses that ascertainment, storage, and display of an amplitude strength of the CS respiration, consisting of hypopneas versus apneas, are performed (see fig. 7, 710 and 720 of Armitstead, paragraph 0107 of Armitstead, Armitstead discloses that the display panel 750 is displaying hypopnea in panel 710 and apnea in panel 720, the panels are signal representing a patient’s respiratory flow, which would include an amplitude for the vertical access, furthermore, since panel 710 and panel 720 are side by side, relatively, it is 710 versus 720, furthermore, in order to communicate the flow pattern in a time frame the signal must be ascertained and stored).
Regarding claim 15, the modified Armitstead discloses that the monitoring unit uses a value of a period length between respiration events as a further indication of a presence of CS respiration (see paragraph 0041 of Armitstead, Armitstead discloses checking a cycle length of the apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, and by comparing the cycle lengths of the breathing patterns with a typical cycle length associated with CSR, a conclusion may be made whether the patient suffers from CSR, further see paragraph 0083 with reference to paragraph 0059).
Regarding claim 16, the modified Armitstead discloses that the presence of CS respiration is presumed when period lengths are each at least 40 seconds and at most 90 seconds (see paragraphs 0041 and 0083 of Armitstead).
Regarding claim 17, the modified Armitstead discloses that the monitoring unit considers a number of respiration events sorted into the first validity and the second validity classes together with a total number of all events considered in an event analysis in the sense of a conclusiveness test (see the rejection to claim 3, the first validity is apnea and second validity is hypopnea, Armitstead further discloses in paragraphs 0059 and 0083 that each cycle length of a cluster of apneas and hypopneas can be presented as bins, and each cycle length data are spaced 10 seconds apart, and that the average cycle length of various bins are viewed, therefore, the bins are the events considered in an event analysis in the sense of a conclusiveness test).
Regarding claim 18, the modified Armitstead discloses that the differentiation between a central apnea, classified as a valid even, and an invalid obstructive apnea is carried out by the monitoring unit on a basis of an analysis of the at least one flow signal and the at least one pressure signal (see paragraph 0071 of Armitstead, Armitstead discloses that the jump feature 235 is used to distinguish between obstructive apneas/hypopneas and central apneas/hypopneas, and by classifying an event as a central apneas, the device would be classifying it as a valid event, furthermore, Armitstead discloses in paragraph 0115 that flow signals are computer from differential pressure signal, therefore, to distinguish the monitoring unit has to rely on flow signal which is taken from pressure signal).
Regarding claim 19, the modified Armitstead discloses that a beginning of an apnea is recognized on a basis of a flow variation and an end of the apnea is recognized on the basic of a flow variation (see 210 (apnea) in fig. 2 and paragraph 0052 discloses that the apnea is detected relative to flow variations, paragraph 0011 of Armitstead, Armitstead discloses that the apnea is detected by duration of each event, Armitstead further discloses in paragraph 0019 that assessing the data to detect apnea may include calculating the duration of at least one apneic period and further discloses in paragraph 0011 that the respiratory data is respiratory flow, therefore by looking at the duration of an apnea event by utilizing data such as a flow variation, one can detect an apnea, Armitstead further discloses in paragraph 0046 that the method of detecting apnea is described in US PAT 6,138,675, which involves looking at flow variation (see abstract)).
Regarding claim 20, the modified Armitstead discloses that obstructive apnea is detected by an occurrence of a short, additional pressure increases at the end of the apnea (see fig. 5A and paragraphs 0066 ad 0071 of Armitstead, Armitstead discloses that the signal morphology after an obstructive apnea is shown in fig. 5A, and as shown, there is an increase in flow which increase to an increase in pressure at the end of the apnea, wherein the duration is relatively short).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Meier (2006/0249149) as applied to claim 1 above, and further in view of Kane (2006/0070624).
Regarding claim 12, the modified Armitstead discloses recognizing a CS respiration (see rejection to claims 1 and 8), but fails to disclose that recognized CS respiration is confirmed by analysis of pulse oximeter signals.
However, Shelly teaches that recognizing CS respiration can be confirmed by analysis of pulse oximeter signals (paragraph 0162).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device by having recognizing a CS respiration as taught by the modified Armitstead be confirmed by analysis of pulse oximeter signals as taught by Kane for the purpose of improving accuracy by double checking a CS respiration episode with analysis of pulse oximeter signals.
Regarding claim 14, the modified Armitstead discloses that the signals from pulse oximeter is being used in combination with the respiration device, therefore, after the modification, the pulse oximeter would have to be connected to the respiration device via an interface, and would have to be able to record data in time correlated matter in order to confirm a CSR event (see paragraphs 0162-0164 of Kane).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Meier (2006/0249149) as applied to claim 1 above, and further in view of Lau (2012/0016218).
Regarding claim 13, the modified Armitstead discloses utilizing signals from pulse oximeter, but fails to specifically disclose that the pulse frequency are used as pulse oximeter signals.
However, Lau teaches detecting CSR by using pulse oximetry signal, wherein the pulse frequency are used as pulse oximeter signals (see abstract, claims 1-4, and paragraph 0062, Lau discloses frequency analysis of the signals).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and pulse oximeter signals of the modified Armitstead to have a pulse frequency be used as a pulse oximeter signals as taught by Lau for the purpose of providing an alternative method of detecting CSR using pulse oximetry signals.
Claims 1-9, 11 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Rao (2013/0317765).
Regarding claim 1, Armitstead discloses a respiration device (device shown in fig. 9 and figs. 1-3), wherein the device comprises at least one respiration unit for generating an airflow for respiration (the at least one respiration unit is the flow generator, see paragraph 0036) and at least one monitoring unit (the flow sensor shown in fig. 9 and paragraph 0043, and the controller 904/CSR detector 100, see paragraphs 0045 and 0114) for 5detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal from at least one associated sensor unit (the flow sensor shown in fig. 9 and paragraph 0043) to detect at least one flow property of an airflow (paragraph 0043, Armitstead discloses flow sensor for capturing air flow) for 10the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event and sort events into classes comprising at least one first class comprising events which are relevant for CS (see paragraphs 0050, 0052-0056, 0062, and 0103-0104, Armitstead discloses that the Cheyne-Stokes detection module 108 classifies a period of Cheyne-Stokes respiration by analyzing clusters of apneas and hypopneas, furthermore, Armitstead discloses there are three useful raw features, first is the cycle length, second useful raw feature is the shape feature, and third useful feature is the duty cycle, and for each raw features are classified, the raw features being classified are used to determined CS therefore they are relevant to CS, Armitstead further discloses in paragraph 0041 that cycle length of apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, therefore, by indicating what is an apnea or hypopnea, the device would have to classify the captured flow pattern as such, paragraph 0051, Armitstead discloses that the Cheyne-Stokes detection module would calculate three raw features including a cycle length histogram for cluster of apneas and hypopneas, alternatively, Armitstead discloses in paragraph 0071 that the jump feature can be used to distinguish between obstructive apneas/hypopneas class and central apneas/hypopneas, therefore, the first class is the central apneas/hypopneas and the obstructive apneas/hypopneas class), but fails to disclose sorting into two classes comprising at least one second class comprising events which are irrelevant for CS 15respiration.
However, Rao teaches a respiration device (entire device in fig. 1) comprising a monitoring unit (104 and 106, fig. 1, paragraphs 0064-0065) for classifying an event that is irrelevant for CS respiration (see paragraphs 0066-0069, the device detects different form of leaks and further discloses in paragraphs 0021, 0030, 0074 that the processor is configured to classify the leak even from a plurality of different types of leak).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respiration device of Armitstead to classify and sort an event which is irrelevant for CS respiration as taught by Rao for the purpose of providing an adaptive ventilator that would adjust the flow to the patient based on the amount of leak, thereby providing comfort to the patient (paragraphs 0035-0036 and 0235 of Rao) and to provide a ventilator that provides a warning concerning the leak severity (see paragraph 0073 of Rao).
Regarding claim 2, the modified Armitstead discloses that the events of the second class comprises a leak (see paragraphs 0066-0069 of Rao, the device detects different form of leaks and further discloses in paragraphs 0021, 0030, 0074 that the processor is configured to classify the leak even from a plurality of different types of leak).
Regarding claim 3, the modified Armitstead discloses that the monitoring unit is configured to sort the events of the first class into at least two validity classes for the event analysis, comprising a first validity class comprising events which typically occur in a case of CS respiration and a second validity class comprising events which typically do not occur in a case of CS respiration (Armitstead discloses in paragraph 0041 that cycle length of apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, therefore, by indicating what is an apnea or hypopnea, the device would have to classify the captured flow pattern as such, wherein the first validity class is apnea and the second validity class is hypopnea, paragraph 0051, Armitstead discloses that the Cheyne-Stokes detection module would calculate three raw features including a cycle length histogram for cluster of apneas and hypopneas, wherein the classification of apneas would be first validity class and the hypopnea would be a second validity class, alternatively, Armitstead discloses in paragraph 0071 that the jump feature can be used to distinguish between obstructive apneas/hypopneas and central apneas/hypopneas, therefore, the first validity is the central apneas/hypopneas and the second validity is the obstructive apneas/hypopneas).
Regarding claim 4, the modified Armitstead discloses that the events of the first validity comprises central apnea (see alternative interpretation in claim 3, Armitstead discloses a first validity comprises central apneas).
Regarding claim 5, the modified Armitstead discloses that the events of the second validity comprises obstructive apneas (see alternative interpretation in claim 3, Armitstead discloses a second validity class including obstructive apnea).
Regarding claim 6, the modified Armitstead discloses that the monitoring unit is configured to register the presence of CS respiration when at least three events occur in chronological succession and in this case at least two of the at least three events correspond to the first validity and at most one event of the at least three events corresponds to the second validity class. See paragraphs 0010, Armitstead discloses that cycle length histogram may be generated based on events and CS respiration may be detected based on the generated cycle length histogram. Further stated in paragraph 0059 that the cycle length histogram gathers the cycle length data for a cluster of apneas and hypopneas during the CSR period, based on its length, associates each cycle with one of a plurality of bins, and each bins can be spaced 10 seconds apart up to 105, therefore, there are more than 3 or 4 events being monitored, wherein each event is considered as a bin. Armitstead further discloses in paragraph 0083 that during CSR period, it would be expected that the average cycle length would be between 40 to 90 seconds, thus, in one example the region of interest may be defined as the bins, which cover cycle lengths between 40 and 90 seconds. When the patient experience two apneas and one hypopneas within time frame of 40-90 seconds, the apnea would be considered as the first validity class and the hypopnea would be considered as the second validity class.
Regarding claim 7, the modified Armitstead discloses that at least four events are analyzed (see paragraphs 0059 and 0083 of Armitstead, Armitstead discloses that each apnea or hypopnea event is classified as a bin, and each bin can be arranged as 10 seconds apart up to 110 seconds, however, 40 seconds to 90 seconds to determine a CSR period, therefore, at least 4 events would be analyzed).
Regarding claim 8, the modified Armitstead discloses that the device is configured to output a corresponding notification to a user in the event of a register CS respiration (see paragraph 0113 of Armitstead, Armitstead discloses a display interface 810 to output CSR detection reports, paragraphs 0010 and 0012 of Armitstead discloses that the apparatus is for indicating a presence of Cheyne-Stokes respiration, paragraph 0107 of Armitstead discloses panel 760 displays notification that a CSR has been positively detected).
Regarding claim 9, the modified Armitstead discloses that the device is configured, in the event of a registered CS respiration, to set the respiration unit to at least one respiration mode for respiration in a case of CS respiration (see paragraph 0116 of Armitstead, Armitstead discloses that the therapeutic pressure levels may be automatically adjusted in response to the detection of CSR conditions).
Regarding claim 11, the modified Armitstead discloses that ascertainment, storage, and display of an amplitude strength of the CS respiration, consisting of hypopneas versus apneas, are performed (see fig. 7, 710 and 720 of Armitstead, paragraph 0107 of Armitstead, Armitstead discloses that the display panel 750 is displaying hypopnea in panel 710 and apnea in panel 720, the panels are signal representing a patient’s respiratory flow, which would include an amplitude for the vertical access, furthermore, since panel 710 and panel 720 are side by side, relatively, it is 710 versus 720, furthermore, in order to communicate the flow pattern in a time frame the signal must be ascertained and stored).
Regarding claim 15, the modified Armitstead discloses that the monitoring unit uses a value of a period length between respiration events as a further indication of a presence of CS respiration (see paragraph 0041 of Armitstead, Armitstead discloses checking a cycle length of the apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, and by comparing the cycle lengths of the breathing patterns with a typical cycle length associated with CSR, a conclusion may be made whether the patient suffers from CSR, further see paragraph 0083 with reference to paragraph 0059).
Regarding claim 16, the modified Armitstead discloses that the presence of CS respiration is presumed when period lengths are each at least 40 seconds and at most 90 seconds (see paragraphs 0041 and 0083 of Armitstead).
Regarding claim 17, the modified Armitstead discloses that the monitoring unit considers a number of respiration events sorted into the first validity and the second validity classes together with a total number of all events considered in an event analysis in the sense of a conclusiveness test (see the rejection to claim 3, the first validity is apnea and second validity is hypopnea, Armitstead further discloses in paragraphs 0059 and 0083 that each cycle length of a cluster of apneas and hypopneas can be presented as bins, and each cycle length data are spaced 10 seconds apart, and that the average cycle length of various bins are viewed, therefore, the bins are the events considered in an event analysis in the sense of a conclusiveness test).
Regarding claim 18, the modified Armitstead discloses that the differentiation between a central apnea, classified as a valid even, and an invalid obstructive apnea is carried out by the monitoring unit on a basis of an analysis of the at least one flow signal and the at least one pressure signal (see paragraph 0071 of Armitstead, Armitstead discloses that the jump feature 235 is used to distinguish between obstructive apneas/hypopneas and central apneas/hypopneas, and by classifying an event as a central apneas, the device would be classifying it as a valid event, furthermore, Armitstead discloses in paragraph 0115 that flow signals are computer from differential pressure signal, therefore, to distinguish the monitoring unit has to rely on flow signal which is taken from pressure signal).
Regarding claim 19, the modified Armitstead discloses that a beginning of an apnea is recognized on a basis of a flow variation and an end of the apnea is recognized on the basic of a flow variation (see 210 (apnea) in fig. 2 and paragraph 0052 discloses that the apnea is detected relative to flow variations, paragraph 0011 of Armitstead, Armitstead discloses that the apnea is detected by duration of each event, Armitstead further discloses in paragraph 0019 that assessing the data to detect apnea may include calculating the duration of at least one apneic period and further discloses in paragraph 0011 that the respiratory data is respiratory flow, therefore by looking at the duration of an apnea event by utilizing data such as a flow variation, one can detect an apnea, Armitstead further discloses in paragraph 0046 that the method of detecting apnea is described in US PAT 6,138,675, which involves looking at flow variation (see abstract)).
Regarding claim 20, the modified Armitstead discloses that obstructive apnea is detected by an occurrence of a short, additional pressure increases at the end of the apnea (see fig. 5A and paragraphs 0066 ad 0071 of Armitstead, Armitstead discloses that the signal morphology after an obstructive apnea is shown in fig. 5A, and as shown, there is an increase in flow which increase to an increase in pressure at the end of the apnea, wherein the duration is relatively short).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Rao (2013/0317765) as applied to claim 1 above, and further in view of Kane (2006/0070624).
Regarding claim 12, the modified Armitstead discloses recognizing a CS respiration (see rejection to claims 1 and 8), but fails to disclose that recognized CS respiration is confirmed by analysis of pulse oximeter signals.
However, Shelly teaches that recognizing CS respiration can be confirmed by analysis of pulse oximeter signals (paragraph 0162).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device by having recognizing a CS respiration as taught by the modified Armitstead be confirmed by analysis of pulse oximeter signals as taught by Kane for the purpose of improving accuracy by double checking a CS respiration episode with analysis of pulse oximeter signals.
Regarding claim 14, the modified Armitstead discloses that the signals from pulse oximeter is being used in combination with the respiration device, therefore, after the modification, the pulse oximeter would have to be connected to the respiration device via an interface, and would have to be able to record data in time correlated matter in order to confirm a CSR event (see paragraphs 0162-0164 of Kane).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Armitstead (2015/0038867) in view of Rao (2013/0317765) as applied to claim 1 above, and further in view of Lau (2012/0016218).
Regarding claim 13, the modified Armitstead discloses utilizing signals from pulse oximeter, but fails to specifically disclose that the pulse frequency are used as pulse oximeter signals.
However, Lau teaches detecting CSR by using pulse oximetry signal, wherein the pulse frequency are used as pulse oximeter signals (see abstract, claims 1-4, and paragraph 0062, Lau discloses frequency analysis of the signals).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and pulse oximeter signals of the modified Armitstead to have a pulse frequency be used as a pulse oximeter signals as taught by Lau for the purpose of providing an alternative method of detecting CSR using pulse oximetry signals.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. 11,602,604.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claims are minor and obvious from each other. For example, the instant claims 1-20 are a broader version of the patented claims 1-20 (i.e., the instant claims 1-20 do not include that the monitoring unit is configured to only consider the classified events of the at least one first class in an even analysis when determining a presence of CS respiration, wherein once the classified events of the first class have been sorted and considered, the even analysis is configured to analyze period lengths between chronologically successive events of the at least one first class to determine the presence of CS respiration as in the patented claims 1-20). In the instant claims 1-20, the device is included in the patented claims 1-20. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claims 1-20 do not differ in scope from the patented claims 1-20. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claim 1, the following comparison between the patented claim 1 and the instant application claim 1, underlined features in the patented claim show what elements have been excluded in the presentation of the instant application claim.
Application claim 1
Patented claim 1
1. A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal and/or at least one pressure signal from at least one associated sensor unit to detect at least one flow property and/or at least one pressure property of an airflow for the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS respiration.
1. A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal and/or at least one pressure signal from at least one associated sensor unit to detect at least one flow property and/or at least one pressure property of an airflow for the respiration and to analyze the at least one flow signal and/or at least one pressure signal in order to classify a plurality of respiration events, and further being configured to sort the classified events into at least two classes, the at least two classes comprising at least one first class comprising the classified events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising the classified events which are irrelevant for CS respiration, wherein after the classified events have been sorted into the at least one first class and the at least one second class, the monitoring unit is configured to only consider the classified events of the at least one first class in an event analysis when determining a presence of CS respiration, wherein once the classified events of the first class have been sorted and considered, the event analysis is configured to analyze period lengths between chronologically successive events of the at least one first class to determine the presence of CS respiration.
The instant claim 1 is being rejected by the patented claims 1-20.
The instant claim 2 is being rejected by the patented claim 2.
The instant claim 3 is being rejected by the patented claims 3-11.
The instant claim 4 is being rejected by the patented claim 4.
The instant claim 5 is being rejected by the patented claim 5.
The instant claim 6 is being rejected by the patented claims 6-7.
The instant claim 7 is being rejected by the patented claim 7.
The instant claim 8 is being rejected by the patented claim 12.
The instant claim 9 is being rejected by the patented claim 13.
The instant claim 10 is being rejected by the patented claim 14.
The instant claim 11 is being rejected by the patented claim 15.
The instant claim 12 is being rejected by the patented claims 16-18.
The instant claim 13 is being rejected by the patented claim 17.
The instant claim 14 is being rejected by the patented claim 18.
The instant claim 15 is being rejected by the patented claims 19-20.
The instant claim 16 is being rejected by the patented claim 20.
The instant claim 17 is being rejected by the patented claim 8.
The instant claim 18 is being rejected by the patented claims 9-11.
The instant claim 19 is being rejected by the patented claims 10-11.
The instant claim 20 is being rejected by the patented claim 11.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 of US Patent No. 10,159,810.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the patented claims are minor and obvious from each other. For example, the instant claim 1 is a broader version of the patented claims 7-11 (i.e., the instant claim 1 does not include that the monitoring unit being configured to carry out at least one event analysis to recognize an occurrence of chronologically successive events which is characteristic for Cheyne-Stokes respiration and for this purpose to ascertain period lengths between the chronologically successive events and to compare ascertained period lengths at least partially to one another and to register a presence of Cheyne-Stokes respiration when the compared period lengths deviate by less than 40% from one another as in the patented claims 7-11). In the instant claim 1, the device is included in the patented claims 7-11. Any infringement over the patented claims would also infringe over the instant claim. Therefore, the instant claim 1 does not differ in scope from the patented claims 7-11. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claim 1, the following comparison between the patented claim 7 and the instant application claim 1, underlined features in the patented claim show what elements have been excluded in the presentation of the instant application claim.
Application claim 1
Patented claim 7
1. A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal and/or at least one pressure signal from at least one associated sensor unit to detect at least one flow property and/or at least one pressure property of an airflow for the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS respiration.
1. (for reference) A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on the basis of monitoring of the at least one respiration parameter, the monitoring unit being configured to carry out at least one event analysis to recognize an occurrence of chronologically successive events which is characteristic for Cheyne-Stokes respiration and for this purpose to ascertain period lengths between the chronologically successive events and to compare ascertained period lengths at least partially to one another and to register a presence of Cheyne-Stokes respiration when the compared period lengths deviate by less than 40% from one another.
7. The respiration device of claim 1, wherein the monitoring unit is configured to sort events into at least two relevance classes, comprising at least one first relevance class comprising events which are relevant for Cheyne-Stokes respiration and at least one second relevance class comprising events which are irrelevant for Cheyne-Stokes respiration.
The instant claim 1 is being rejected by the patented claims 7-11.
The instant claim 2 is being rejected by the patented claim 8.
The instant claim 3 is being rejected by the patented claims 9-11.
The instant claim 4 is being rejected by the patented claim 10.
The instant claim 5 is being rejected by the patented claim 10.
The instant claim 6 is being rejected by the patented claim 11.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 12,053,581.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claims are minor and obvious from each other. For example, the instant claims 1-20 are a broader version of the patented claims 1-19 (i.e., the instant claims 1-20 do not include that the monitoring unit is configured to recognize an occurrence of chronologically successive events which is characteristic of CS respiration, to ascertain respiration amplitudes for at least three chronologically successive inspiration and expiration events, and to compare the ascertained respiration amplitudes to one another and to register a presence of CS respiration when the compared respiration amplitudes deviate by at least 25% from one another as in the patented claims 1-19). In the instant claims 1-20, the device is included in the patented claims 1-19. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claims 1-20 do not differ in scope from the patented claims 1-19. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding the instant application claim 1, the following comparison between the patented claim 1 and the instant application claim 1, underlined features in the patented claim show what elements have been excluded in the presentation of the instant application claim.
Application claim 1
Patented claim 1
1. A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal and/or at least one pressure signal from at least one associated sensor unit to detect at least one flow property and/or at least one pressure property of an airflow for the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS respiration.
1. A respiration device, wherein the device comprises at least one respiration unit for generating an airflow for respiration and at least one monitoring unit for detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal and/or at least one pressure signal from at least one associated sensor unit to detect at least one flow property and/or at least one pressure property of an airflow for the respiration and to analyze the at least one flow signal and/or at least one pressure signal in order to classify a plurality of respiration events, and further being configured to sort the classified events into at least two classes comprising at least one first class comprising the classified events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising the classified events which are irrelevant for CS respiration, wherein the monitoring unit is configured to recognize an occurrence of chronologically successive events which is characteristic of CS respiration, to ascertain respiration amplitudes for at least three chronologically successive inspiration and expiration events, and to compare the ascertained respiration amplitudes to one another and to register a presence of CS respiration when the compared respiration amplitudes deviate by at least 25% from one another.
The instant claim 1 is being rejected by the patented claims 1-19.
The instant claim 2 is being rejected by the patented claim 2.
The instant claim 3 is being rejected by the patented claims 3-11.
The instant claim 4 is being rejected by the patented claim 4.
The instant claim 5 is being rejected by the patented claim 5.
The instant claim 6 is being rejected by the patented claims 6-7.
The instant claim 7 is being rejected by the patented claim 7.
The instant claim 8 is being rejected by the patented claim 12.
The instant claim 9 is being rejected by the patented claim 13.
The instant claim 10 is being rejected by the patented claims 1-19.
The instant claim 11 is being rejected by the patented claim 14.
The instant claim 12 is being rejected by the patented claims 15-19.
The instant claim 13 is being rejected by the patented claim 16.
The instant claim 14 is being rejected by the patented claim 17.
The instant claim 15 is being rejected by the patented claims 18-19.
The instant claim 16 is being rejected by the patented claim 19.
The instant claim 17 is being rejected by the patented claim 8.
The instant claim 18 is being rejected by the patented claims 9-11.
The instant claim 19 is being rejected by the patented claims 10-11.
The instant claim 20 is being rejected by the patented claim 11.
Allowable Subject Matter
Claim 10 is allowed over the prior art.
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and the double patenting rejection (alternatively, the double patenting rejection can be overcome by filing a Terminal Disclaimer) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for indicating allowable subject matter: The closest prior art of record Armitstead (2015/0038867) and Meier (2006/0249149) do not specifically disclose the claimed apparatus as presented in the claim 10.
Regarding claim 1, Armitstead discloses a respiration device (device shown in fig. 9 and figs. 1-3), wherein the device comprises at least one respiration unit for generating an airflow for respiration (the at least one respiration unit is the flow generator, see paragraph 0036) and at least one monitoring unit (the flow sensor shown in fig. 9 and paragraph 0043, and the controller 904/CSR detector 100, see paragraphs 0045 and 0114) for 5detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor at least one flow signal from at least one associated sensor unit (the flow sensor shown in fig. 9 and paragraph 0043) to detect at least one flow property of an airflow (paragraph 0043, Armitstead discloses flow sensor for capturing air flow) for 10the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event and sort events into classes comprising at least one first class comprising events which are relevant for CS (see paragraphs 0050, 0052-0056, 0062, and 0103-0104, Armitstead discloses that the Cheyne-Stokes detection module 108 classifies a period of Cheyne-Stokes respiration by analyzing clusters of apneas and hypopneas, furthermore, Armitstead discloses there are three useful raw features, first is the cycle length, second useful raw feature is the shape feature, and third useful feature is the duty cycle, and for each raw features are classified, the raw features being classified are used to determined CS therefore they are relevant to CS, Armitstead further discloses in paragraph 0041 that cycle length of apnea and hypopnea for patients with CSR will vary between 40 and 90 seconds, therefore, by indicating what is an apnea or hypopnea, the device would have to classify the captured flow pattern as such, paragraph 0051, Armitstead discloses that the Cheyne-Stokes detection module would calculate three raw features including a cycle length histogram for cluster of apneas and hypopneas, alternatively, Armitstead discloses in paragraph 0071 that the jump feature can be used to distinguish between obstructive apneas/hypopneas class and central apneas/hypopneas, therefore, the first class is the central apneas/hypopneas and the obstructive apneas/hypopneas class).
However, Meier discloses a respiration device (see device in fig. 3, paragraph 0117), wherein the device comprises at least one respiration unit (34, fig. 3, paragraph 0167) for generating an airflow for respiration and at least one monitoring unit (associated controller 40 and pressure module 37 and pressure sensor, see fig. 3, paragraphs 0169 and 0199, alternatively, Meier discloses that the CPAP device would have flow and pressure measuring device for measuring flow and pressures) for 5detecting at least one respiration parameter and for classifying events in the respiration on a basis of monitoring the at least one respiration parameter, the monitoring unit being configured to monitor pressure signal from at least one associated sensor unit (pressure module 37, paragraphs 0023 and 0169) to detect the one pressure property of an airflow for 10the respiration and to analyze the at least one flow signal and/or at least one pressure signal on a basis of at least one algorithm in order to classify an event, and further being configured to sort events into at least two classes, comprising at least one first class comprising events which are relevant for CS (Cheyne-Stokes) respiration and at least one second class comprising events which are irrelevant for CS 15respiration (paragraph 0036, Meier discloses that apnea phase is to be classified as central or obstructive, which is considered as first class comprising events which are relevant for CS (Cheyne-Stokes), Meier discloses in paragraph 0037 that the invention evaluation features are generated for phase with Cheyne-stokes respiration and snoring phase, therefore, the classification of central apnea and obstructive apnea would be relevant for CS respiration, Meier further discloses in paragraph 0080 that snoring is classified, wherein snoring can be considered as not being relevant for Cheyne-stokes per claim 2 of the instant application).
However, Armitstead and Meier fail to disclose that the monitoring unit is configured to carry out at least one event analysis to recognize an occurrence of chronologically successive events which is characteristic of CS respiration, to ascertain respiration amplitudes for at least three chronologically successive inspiration and expiration events, and to compare the ascertained respiration amplitudes to one another and to register a presence of CS respiration when the compared respiration amplitudes deviate by at least 25% from one another. It is noted the at least one event analysis is being interpreted as including to recognize an occurrence of chronologically successive events which is characteristic of CS respiration, to ascertain respiration amplitudes for at least three chronologically successive inspiration and expiration events, and to compare the ascertained respiration amplitudes to one another and to register a presence of CS respiration when the compared respiration amplitudes deviate by at least 25% from one another. Therefore, to modify Armitstead and Meier to arrive at the claimed invention would not have been obvious and would be based upon improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Armitstead (2012/0088992) is cited to show a Cheyne-stokes diagnosis system comprising classifying apneas and snore.
Armitstead (2011/0203588) is cited to show a respiratory device for classifying a snoring event.
Alshaer (2016/0045161) is cited to show a respiratory device for classifying a snoring event.
Rapoport (5,803,066) is cited to show a method and apparatus configured to classify central or obstructive apneas.
Moussavi (2008/0243017) is cited to show detecting breathing utilizing oximetric sensor.
Shelly (2013/0125892) is cited to show a device utilizing pulse oximeter to detect CSR.
Armitstead (2012/0190998) is cited to show a device configured to classify apnea or hypopnea as obstructive or central.
Wright (6,832,609) is cited to show a device configured to have an apnea hypopnea index and classification of each event.
Berthon-Jones (6,138,675) is cited to show determination of the occurrence of an apnea.
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/TU A VO/Primary Examiner, Art Unit 3785
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