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
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 9 is objected to because of the following informalities:
It appears that “cheat” in line 3 of claim 9 is a misspelling, and should instead be “chest”. For examination purposes, “cheat” in line 3 of claim 9 will be interpreted and read the same as “chest”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1-4 are directed to a device, which is within one of the four statutory categories (i.e., a machine or apparatus). See MPEP § 2106.03. Claims 5-9 are directed to a method, which is also within one of the four statutory categories (i.e., a process). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 Revised PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-9 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1 and 5 include limitations that recite an abstract idea. Note that independent claim 1 cover a device, while independent claim 5 covers the matching method. Specifically, independent claim 1 recites (and independent claim 5 substantially recites) the following limitations:
A device comprising:
a local acceleration sensor mountable on a chest or upper abdomen of a patient for sensing local accelerations or changes in a position, including orientation or displacement, of the local acceleration sensor;
a data acquisition system and data storage for data analysis and comparison
with past data; and
a processor and a non-transitory, computer-readable storage medium in communication with the processor, wherein a computer-readable program code is embodied in the storage medium, and wherein the computer-readable program code is configured to classify phases of a respiratory cycle, including inspiration and expiration phases, and polyphasic motions within said phases, to calculate energy of said polyphasic motions based on sensed information of said local acceleration sensor and to classify severity of cardiac decompensation by calculating an excessive energy index (EEi) that compares excessive energy that appears in said polyphasic motions to energy required for inspiration at a basic respiratory rate.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., a method for data analysis and comparing data with past data; classifying phases of a respiratory cycle; calculating energy of motions from a sensor; comparing excessive energy from the motions to energy required for inspiration at a basic respiratory rate; and classifying the severity of cardiac decompensation by calculating an excessive energy index from the comparison). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claim 1 which are not underlined), the context of claims 1 and 5 encompasses a concept that is capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., a method for data analysis and comparing data with past data; classifying phases of a respiratory cycle; calculating energy of motions from a sensor; comparing excessive energy from the motions to energy required for inspiration at a basic respiratory rate; and classifying the severity of cardiac decompensation by calculating an excessive energy index from the comparison).
The aforementioned claim limitations described in claims 1 and 5 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) comparing data with past data (i.e., a type of observation, evaluation, judgment, and/or opinion where a person can mentally compare current data with past data); (2) calculating energy of motions from a sensor (i.e., a type of observation, evaluation, and/or judgment where a person can manually calculate energy of motions using a mathematical equation); (3) comparing excessive energy from the motions to energy required for inspiration at a basic respiratory rate (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally compare energy from the motions to energy required for inspiration at a basic respiratory rate); and (4) classifying the severity of cardiac decompensation by calculating an excessive energy index from the comparison (i.e., a type of observation, evaluation, judgment, and/or opinion mentally classify the severity of cardiac event based on data from an excessive energy index). If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(III). Further, Examiner notes that many of the aforementioned claim limitations described in claims 1 and 5 may also be classified as analogous to claim limitations directed to mathematical relationships, mathematical formulas or equations, and mathematical calculations (i.e., the Mathematical Concepts Category of abstract ideas, which covers mathematical relationships, mathematical formulas or equations, and mathematical calculations), because the limitations directed to “calculating energy of said polyphasic motions based on sensed information of said local acceleration sensor” and “calculating an excessive energy index (EEi) that compares excessive energy that appears in said polyphasic motions to energy required for inspiration at a basic respiratory rate”, merely recite limitations which represent mathematical relationships, formulas, equations, and calculations (e.g., see Applicant’s specification as filed on November 14, 2024, at p. 18-19 where Applicant provides several formulas for calculating the Excessive Effort Index, Breathing Energy, the Excessive Energy Index (EEi), and other energy calculations). See MPEP § 2106.04(a)(2)(I). Accordingly, claims 1 and 5 recite an abstract idea that falls within the Mental Processes and Mathematical Concepts groupings of abstract ideas.
Furthermore, Examiner notes that dependent claims 2-4 and 6-9 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claim 9 provides limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A; and (2) dependent claims 2-4 and 6-8 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 2-4 and 6-8 merely recite additional ratios and calculations contained in the Excessive Energy Index (EEi) (i.e., these steps are deemed to be further mental steps involving a human performing the steps mentally with the aid of pen and paper and/or mathematical relationships, formulas, equations and calculations).
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h).
Following Prong Two of Step 2A of the 2019 Revised PEG, this judicial exception is not integrated into a practical application because they do not impose any meaningful limits on practicing the abstract idea. In the present case, for representative independent claim 1 (similar to claim 5), the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A device comprising (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
a local acceleration sensor mountable on a chest or upper abdomen of a patient (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for sensing local accelerations or changes in a position, including orientation or displacement, of the local acceleration sensor (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
a data acquisition system and data storage (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for data analysis and comparison with past data; and
a processor (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) and a non-transitory, computer-readable storage medium in communication with the processor, wherein a computer-readable program code is embodied in the storage medium, and wherein the computer-readable program code is configured (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) to classify phases of a respiratory cycle, including inspiration and expiration phases, and polyphasic motions within said phases, to calculate energy of said polyphasic motions based on sensed information of said local acceleration sensor and to classify severity of cardiac decompensation by calculating an excessive energy index (EEi) that compares excessive energy that appears in said polyphasic motions to energy required for inspiration at a basic respiratory rate.
However, the recitation of these limitations is made with a high-level of generality (i.e., using generic computer devices to perform the abstract mental process of: data analysis and comparing data with past data; classifying phases of a respiratory cycle; calculating energy of motions from a sensor; comparing excessive energy from the motions to energy required for inspiration at a basic respiratory rate; and classifying the severity of cardiac decompensation by calculating an excessive energy index from the comparison), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; and (2) adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.05(f), (g).
- The following is an example of a court decisions that demonstrates merely applying instructions by reciting a computer structure as a tool to implement the claimed invention (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. V. CLS Bank Int’l – similarly, the additional elements recited in claims 1 and 5 described in the Prong One analysis of Step 2A above, invokes general-purpose computer (i.e., the device; local acceleration sensor; data acquisition system and data storage; data acquisition system and data storage; processor; and non-transitory, computer-readable storage medium, wherein a computer-readable program code is embodied in the storage medium) to perform the commonplace business method for sensing and classifying a person’s respiratory activity; and
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g., see Intellectual Ventures I LLC v. Capital One Bank (USA) – similarly, the non-transitory, computer-readable storage medium, wherein a computer-readable program code is embodied in the storage medium are examples of generic software that are used to tailor information (i.e., software used to make the comparisons between the energy phases and classify the respiratory activity of the patient).
- The following are examples of insignificant extra-solution activities (e.g., see MPEP § 2106.05(g)):
- Examples of Mere Data Gathering/Mere Data Outputting:
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the step of “sensing local accelerations or changes in a position of a local acceleration sensor”, described in claims 1 and 5, is the equivalent of obtaining and transmitting data from the device with the local acceleration sensor.
Thus, the additional elements in independent claims 1 and 5 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 2-4 and 6-8 do not recite any additional elements outside of those identified as being directed to the abstract idea described above. Examiner notes that dependent claims 9 recites the following additional elements (in bold font below):
comprising using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the cheat at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)), and determining different polyphasic activities at these different sites.
As such, the additional elements in claims 1, 5, and 9 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-9: 1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use 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 whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-9 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-9 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claims 1, 5, and 9 amount to no more than: adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; and adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.05(f), (g). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1, 5, and 9, as recited, the device; local acceleration sensor; data acquisition system and data storage; data acquisition system and data storage; processor; and non-transitory, computer-readable storage medium, wherein a computer-readable program code is embodied in the storage medium; and the steps of: “sensing local accelerations or changes in a position of a local acceleration sensor” and “using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the cheat at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the device; local acceleration sensor; data acquisition system and data storage; processor; and non-transitory, computer-readable storage medium described in claims 1 and 5, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant generally describes these computer components as being part of a device for continuous acquisition and analysis of respiratory dynamics. See Applicant’s specification as filed on November 14, 2024, at p. 14, lines 27-30—p. 15, lines 1-23. For example, the acceleration sensor may be “embodied in a patch and sensor unit.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 3-4. The data acquisition system and data storage and the non-transitory, computer-readable storage medium are disclosed as being part of the “hardware for data complication and filtration and continuous data analysis and comparison with past data.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 5-16. The processor is described as a “central processing unit, which may include additional channels for ECG acquisition with appropriate gain and filtering.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 9-11.
This disclosure demonstrates that the device; local acceleration sensor; data acquisition system and data storage; processor; and non-transitory, computer-readable storage medium described in claim 1 may be embodied by generic computers which are well-known in the art. As such, Applicant’s disclosure demonstrates that these devices are a well-understood, routine, and conventional computers and computer components that are previously known in the industry. See MPEP § 2106.05(d). Therefore, the local acceleration sensor, data acquisition system and data storage, a processor, and a non-transitory, computer-readable storage medium are also deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features directed to: “sensing local accelerations or changes in a position of a local acceleration sensor” and “using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the cheat at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient” - The following represents examples that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – the limitations directed to: “sensing local accelerations or changes in a position of a local acceleration sensor” and “using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the cheat at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient”, are similarly deemed to be well-understood, routine, and conventional activity in the field of monitoring and sensing respiratory data, because they also represent mere collection and transmission of data over a network (i.e., collecting and transmitting the motion data from the patient over a network).
Thus, taken alone, the additional elements of claims 1, 5, and 9 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 5, and 9 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 2-4 and 6-8 (which depend on claims 1 and 5 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 2-4 and 6-8 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1 and 5. Dependent claims 2-4 and 6-8 merely add limitations that further narrow the abstract idea described in independent claims 1 and 5. Therefore, claims 1-9 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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.
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over:
- An et al. (Pub. No. US 2013/0116578), in view of:
- Ni et al. (Pub. No. US 2007/0282215); and
- Halperin et al. (Pub. No. US 2006/0241510).
Regarding claims 1 and 5,
- An et al. (Pub. No. US 2013/0116578) teaches:
- a device comprising (as described in claim 1); and method comprising (as described in claim 5) (An, paragraph [0006]; Paragraph [0006] teaches that the invention relates to systems, devices, and methods that provide one or both of diagnostic monitoring and electrical device-based therapy to the heart of a patient or subject. In particular it relates to, systems, devices, and methods that predict the likelihood that a subject will experience a physiological event, such as a heart failure (HF) related event.):
- a local acceleration sensor mountable on a chest or abdomen of a patient for sensing a quantity of local accelerations or changes in a position, including orientation or displacement, of the local acceleration sensor (as described in both of claims 1 and 5) (An, paragraphs, [0048] and [0180]-[0184], Fig. 1, element 102; In paragraph [0048], the implantable medical device (IMD), which can be an accelerometer is located on or about the chest of the patient (i.e., a local acceleration sensor mountable on a chest or abdomen of a patient). In paragraph [0184], the accelerometer detects motion from respiration. In paragraphs [0180]-[0183], An teaches that the accelerometer is capable of measuring amplitude or energy of the heart, represented by peak amplitude, mean amplitude, median amplitude, root-mean squared amplitude, quantile measure amplitude, or other similar measurement of S3 energy. Therefore, a quantile measure of amplitude is a detection of motion from respiration that is a quantified measurement (i.e., the local acceleration sensor senses a quantity of local accelerations).);
- a data acquisition system and data storage for data analysis and comparison with past data (as described in claim 1) (An, paragraphs [0043], [0081], [0098]; Paragraphs [0043], [0081], and [0098] generally teach a remote server system and database server allows for remote data analysis and storage of data for analysis and comparison to baseline values and reference patients (i.e., a data acquisition system and data storage for data analysis and comparison with past data).); and
- a processor and non-transitory, computer readable storage medium in communication with the processor, wherein a computer-readable program code is embodied in the storage medium (as described in claim 1) (An, paragraphs [0177] and [0178]; Paragraphs [0177] and [0178] generally teach a risk analysis module (i.e. a non-transitory, computer readable storage medium and computer-readable program code), may include a microprocessor.) […] to classify severity of cardiac decompensation (as described in both of claims 1 and 5) (An, paragraph [0178]; Paragraph [0178] generally teaches that the risk analysis module can be programmed to measure one or more physiological parameters to predict patients who are more susceptible to experiencing a heart failure event by obtaining a heart failure risk score, which is indicative of a subject’s susceptibility of suffering from a heart failure event within the following six-to-twelve months (i.e., classifying the severity of cardiac decompensation).).
…
- An does not explicitly teach, however, in analogous art of devices and methods used for detecting disordered breathing, Ni et al. (Pub. No. US 2007/0282215) teaches:
- a computer-readable program code configured to classify phases of a respiratory cycle (as described in both of claims 1 and 5) (Ni, paragraphs [0046], and [0047]; Paragraphs [0046] and [0047] generally teach that the disordered breathing detector detects respiration patterns of one or more respiration cycles and classifies the patterns based on their characteristics (e.g., respiration rate, respiration tidal volume, and duration of respiration cycle intervals) (i.e., classifying phases of a respiratory cycle).) including inspiration and expiration phases, and polyphasic motions within said phases within said phases (as described in both of claims 1 and 5) (Ni, paragraphs [0039] and [0047]; Paragraph [0047] teaches that the respiration patterns may be classified by determining inspiration, expiration, and non-breathing intervals (i.e., the classified phases include inspiration and expiration phases and polyphasic motions within the classified phases). Paragraph [0039] teaches that these features are beneficial for assisting healthcare professionals in accurately detecting disordered breathing patterns in patients during different periods, for example, during sleep, which has been known to contribute to cardiovascular diseases, memory problems, headaches and degradation of social and work related activities.).
Therefore, it would have been obvious to one of ordinary skill in the art of devices and methods used for detecting disordered breathing at the time of the effective filing date of the claimed invention to modify the heart failure risk stratification and detection system and method taught by An, to incorporate the steps and features directed to a computer-readable program code configured to classify phases of a respiratory cycle including inspiration and expiration phases, and polyphasic motions within said phases taught in Ni, order to further assist healthcare professionals in accurately detecting disordered breathing patterns in patients during different periods, for example, during sleep, which has been known to contribute to cardiovascular diseases, memory problems, headaches and degradation of social and work related activities. See Ni, paragraph [0039]; see also MPEP § 2143 G.
- Further, the combination of: An, as modified in view of Ni, does not explicitly teach, however, in analogous art of systems and methods for prediction and early detection of clinical episodes related to heart diseases, Halperin et al. (Pub. No. US 2006/0241510) teaches:
- a computer-readable program code configured to calculate energy of said polyphasic motions based on sensed information of said local acceleration sensor (as described in both of claims 1 and 5) (Halperin, paragraphs [0004], [0106], [0110], and [0678]-[0680], FIG. 20; Paragraph [0678] teaches that the breathing pattern analysis module calculates the ratios of the energy levels of the harmonics and the phase difference between the harmonics (i.e., calculating the energy of polyphasic motions based on sensed information from a local acceleration sensor). Paragraph [0679] further teaches that the breathing pattern analysis module analyzes energy levels of the harmonics and the phase difference between the harmonics versus baseline measurements (where the baseline measurements are normal breathing during sleep – see paragraph [0679]), and interprets deviations from the baseline measurements as an indication that a patient may suffer a heart failure event. The description of deviations from the measurements described in Halperin is the equivalent of “excessive energy”, as described in the claimed invention. For example, in paragraph [0680], Halperin teaches that the accelerometer measures the deviations and determines them to be breathing patterns indicative of substantially elevated energy levels (i.e., excessive energy) during a clinical episode when compared to a pre-episodic, normal state (see Figure 20). See Halperin, paragraph [0680] and FIG. 20 (where line 330 represents energy levels of harmonics during a clinical episode and line 332 represents energy levels of harmonics during normal, non-pre-episodic breathing). Therefore, Halperin teaches comparing excessive energy levels of harmonics and phase differences between harmonics (i.e., energy required for polyphasic motions of inspiration and expiration for clinical episodic breathing patterns and basic respiratory breathing patterns) in order to predict an approaching clinical episode which may be used in early preventative treatment of heart diseases, such as congestive heart failure (i.e., cardiac decompensation). See Halperin, paragraphs [0004], [0106], and [0110].); and
- a computer-readable program code configured to classify severity of cardiac decompensation by calculating an excessive energy index (EEi) that compares excessive energy that appears in said polyphasic motions to energy required for inspiration at a basic respiratory rate (as described in both of claims 1 and 5) (Halperin, paragraphs [0106], [0678], and [0680], Fig. 20; In paragraph [0678], Halperin teaches that the breathing pattern analysis module analyzes energy levels of the harmonics and the phase difference between the harmonics versus baseline measurements, and interprets deviations from the baseline measurements as an indication that a patient may suffer a heart failure event. Deviations from the measurements are interpreted as the equivalent of “excessive energy”, as described in the claimed invention. For example, in paragraph [0680], Halperin teaches that the accelerometer measures the deviations and determines them to be breathing patterns indicative of substantially elevated energy levels (i.e., excessive energy) during a clinical episode when compared to a pre-episodic, normal state (see Figure 20). Paragraph [0106] teaches that these features are beneficial for assisting healthcare professionals in predicting and diagnosing clinical episodes, particularly related to a patient with a history of heart failure occurrences.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for prediction and early detection of clinical episodes related to heart diseases at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of Ni, to incorporate steps and features directed to: (i) calculating ratios of the energy levels of the harmonics and the phase difference between the harmonics; and (ii) measuring the deviations and determining them to be breathing patterns indicative of substantially elevated energy levels during a clinical episode when compared to a pre-episodic, normal state, as taught by Halperin, in order to assist healthcare professionals in predicting and diagnosing clinical episodes, particularly related to a patient with a history of heart failure occurrences. See Halperin, paragraph [0106]; see also MPEP § 2143 G.
Regarding claims 2 and 6,
- The combination of: An, as modified in view of Ni, and Halperin, teaches the limitations of: claim 1 (which claim 2 depends on) and claim 5 (which claim 6 depends on), as described above.
- Halperin further teaches:
- a system which compares:
- a ratio between a sum of energies of said polyphasic motions at high order harmonics of basic respiratory frequencies and energy at all frequencies higher than a basic respiratory frequency, to energy at the basic breathing frequency, at a measurement site of said local acceleration sensor (as described in claims 2 and 6) (Halperin, paragraphs [0119]; Paragraph [0119] generally teaches that one or more of the energy levels of one or more harmonics and of the frequency of the peak are calculated and compared with one or more of the respective baseline ratios. The system uses this comparison to predict the onset of a clinical episode. The at least one energy level of the at least one harmonic and frequency of the peak that is calculated is interpreted as being equivalent to “a sum of energies of said polyphasic motions at high order harmonics of basic respiratory frequencies and energy at all frequencies higher than a basic respiratory frequency” since the sum of these energies is the total energies observed at frequencies higher than what baseline ratios (i.e., the “basic breathing frequency” described in the claimed invention).).
The motivations and rationales for modifying the heart failure risk stratification and detection system and method taught by An, in view of: Ni and Halperin, described in the obviousness rejection of claims 1 and 5 above similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claims 3 and 7,
- The combination of: An, as modified in view of Ni, and Halperin, teaches the limitations of: claim 1 (which claim 3 depends on) and claim 5 (which claim 7 depends on), as described above.
- Halperin further teaches a system and method, wherein:
- said excessive energy index (EEi) is calculated based on an excessive respiratory peak that is pathognomonic to decompensated heart failure (Halperin, paragraph [0244]; breathing rate is determined by identifying a peak in a breathing related frequency range.); and
- the EEi comprises a ratio between an amplitude or energy of said excessive respiratory peak (Halperin, paragraphs [0241]-[0247]; Paragraphs [0241]-[0247] generally teach that the method for predicting an onset of a clinical episode includes determining the breathing rate by identifying a peak in the breathing-related frequency range and determining one or more harmonics of the peak frequency and determining a relationship between the energy level associated with the peak in the breathing-related frequency (i.e., a ration between an amplitude or energy of an excessive respiratory peak).); and an amplitude or energy at an inspiratory wave, at a measurement site of said local acceleration chest sensor (Halperin, paragraphs [0248]-[0250]; Paragraphs [0248]-[0250] generally teach that the second harmonic energy level is compared with the baseline level. The comparison of the energies at the peak frequency at the higher harmonics with the energy at the baseline level can be broadly interpreted as a ratio between the amplitude or energy of an excessive respiratory peak and an amplitude or energy at an inspiratory wave at a measurement site of the local accelerometer sensor.).
The motivations and rationales for modifying the heart failure risk stratification and detection system and method taught by An, in view of: Ni and Halperin, described in the obviousness rejection of claims 1 and 5 above similarly apply to this obviousness rejection, and are incorporated herein by reference.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: An et al. (Pub. No. US 2013/0116578), as modified in view of: Ni et al. (Pub. No. US 2007/0282215) and Halperin et al. (Pub. No. US 2006/0241510), as applied to claims 1 and 5 above, and further in view of:
- Lange et al. (Pub. No. US 2005/0192508).
Regarding claims 4 and 8,
- The combination of: An, as modified in view of: Ni and Halperin, teaches the limitations of: claim 1 (which claim 4 depends on) and claim 5 (which claim 8 depends on), as described above.
- The combination of: An, as modified in view of: Ni and Halperin, does not explicitly teach, however, in analogous art of systems and methods used for prediction and early detection of respiratory-related clinical episodes, Lange et al. (Pub. No. US 2005/0192508) teaches a system and method, wherein:
- said EEi comprises an Activity Duty Cycle (Adc), which comprises a ratio of duration of a vigorous breath activity to an entire duration of breath cycle, the vigorous breath activity being defined as a breath activity during a portion of the breath cycle which is more vigorous than other breath activity in other portions of the breath cycle (as described in claims 4 and 8) (Lange, paragraphs [0004] and [0149]; Paragraph [0149] generally teaches that the breathing duty-cycle includes durations of time when there is a substantial increase in breathing activity divided by the total breath cycle time. Paragraph [0149] further teaches that module 22 interprets a substantial increase in the breathing duty-cycle as indicative of an approaching or progressing attack (i.e., a substantial increase in the breathing duty-cycle is interpreted to be the equivalent of “comparing a ration of a duration of vigorous breathing activity to an entire duration of breath cycle”, because a substantial increase in breathing activity divided by the total breath cycle time (which indicates an approaching or progressing attack) naturally includes more vigorous or labored breathing activity). Paragraph [0004] teaches that this feature is beneficial for increasing the accuracy of monitoring pre-episodic indicators which increases the effectiveness of preventive treatment of chronic diseases.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods used for prediction and early detection of respiratory-related clinical episodes at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of: Ni and Halperin, to incorporate a step and feature directed to classifying substantial increases in the breathing duty-cycle as indicative of an approaching or progressive breathing attack or heart failure event, as taught by Lange, in order to increase the accuracy of monitoring pre-episodic indicators which increases the effectiveness of preventive treatment of chronic diseases. See Lange, paragraph [0004]; see also MPEP § 2143 G.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: An et al. (Pub. No. US 2013/0116578), as modified in view of: Ni et al. (Pub. No. US 2007/0282215) and Halperin et al. (Pub. No. US 2006/0241510), as applied to claim 5 above, and further in view of:
- Derchak (Pub. No. US 2011/0054270);
- Parastoo Kh. Dehkordi et al., Validation of Respiratory Signal Derived from Suprasternal Notch Acceleration for Sleep Apnea Detection, 2011 Annual Conference for the IEEE Engineering in Medicine and Biology Society 3824-3827 (2011), hereinafter referred to as Dehkordi;
- Krzysztof Z. Siejko et al., Feasibility of Heart Sounds Measurements from an Accelerometer within an ICD Pulse Generator, 36 Pacing & Clinical Electrophysiology 334-346 (2013), hereinafter referred to as Siejko; and
- Lee et al. (Pub. No. US 2005/0074741).
Regarding claim 9,
- The combination of: An, as modified in view of: Ni and Halperin, teaches the limitations of: claim 5 (which claim 9 depends on), as described above.
- The combination of: An, as modified in view of: Ni and Halperin, does not explicitly teach, however, in analogous art of systems and methods for monitoring respiratory characteristics of subjects, Derchak (Pub. No. US 2011/0054270) teaches a method, comprising:
- using [additional] local acceleration sensors (Derchak, paragraphs [0006], [0007], [0090], and [0112]; Paragraph [0112] teaches multiple accelerometers may be placed at different parts on a subject’s body (i.e., using additional local acceleration sensors) for acquiring motion-related data at different portions of the body. Paragraphs [0006], [0007], and [0090] teach that this feature is beneficial for increasing the accuracy of quantifying changes in respiratory indicators which increases the effectiveness of preventive treatment of chronic respiratory disorders.) […]
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for monitoring respiratory characteristics of subjects at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of: Ni and Halperin, to incorporate a step and feature directed to using of local acceleration sensors, as taught by Derchak, in order to increase the accuracy of quantifying changes in respiratory indicators which increases the effectiveness of preventive treatment of chronic respiratory disorders. See Derchak, paragraphs [0006], [0007], and [0090]; see also MPEP § 2143 G.
- Further, the combination of: An, as modified in view of: Ni; Halperin; and Derchak, does not explicitly teach, however, in analogous art of monitoring respiratory components for detection of respiratory disorders, Parastoo Kh. Dehkordi et al., Validation of Respiratory Signal Derived from Suprasternal Notch Acceleration for Sleep Apnea Detection, 2011 Annual Conference for the IEEE Engineering in Medicine and Biology Society 3824-3827 (2011), hereinafter referred to as Dehkordi, teaches:
- a local accelerometer placed on an upper sternum, close to a supra-sternal notch (Dehkordi, p. 3824, Col. 2, lines 8-18; On page 3824, column 2, line 14, Dehkordi teaches that an accelerometer is placed on the suprasternal notch of the subject to monitor the respiratory rate. On page 3824, column 2, lines 8-18, Dehkordi teaches that this feature is beneficial for more precisely monitoring respiratory components of breathing disorders by reducing the amount of background noise that is typically included in motion-related respiratory readings that are derived from other portions of the body.) […]
Therefore, it would have been obvious to one of ordinary skill in the art of monitoring respiratory components for detection of respiratory disorders at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of: Ni; Halperin; and Derchak, to incorporate the step and feature directed to placing an accelerometer on the suprasternal notch of a subject to monitor the respiratory rate, as taught by Dehkordi, in order to more precisely monitor respiratory components of breathing disorders by reducing the amount of background noise that is typically included in motion-related respiratory readings that are derived from other portions of the body. See Dehkordi, p. 3824, Col. 2, lines 8-18; see also MPEP § 2143 G.
- Still further, the combination of: An, as modified in view of: Ni; Halperin; Derchak; and Dehkordi, does not explicitly teach, however, in analogous art of devices and methods for monitoring patients with a history of cardiac diseases, Krzysztof Z. Siejko et al., Feasibility of Heart Sounds Measurements from an Accelerometer within an ICD Pulse Generator, 36 Pacing & Clinical Electrophysiology 334-346 (2013), hereinafter referred to as Siejko, teaches:
- a local accelerometer placed on a left side of the chest at a region of cardiac point of maximal impact (PMI) (Siejko, p. 335, Col. 2, lines 17-20, p.336, Col. 2, lines 7-15; On page 335, column 2, lines 17-20, Siejko teaches that a lightweight accelerometer serving as a reference phonocardiogram was placed over the cardiac apex near the point of maximal impact (PMI) (i.e., a local accelerometer is placed on the patient’s chest at a region of cardiac point of maximal impact (PMI)). On page 336, column 2, lines 7-15, Siejko teaches that this feature is beneficial for obtaining information that is known to help in diagnosing a patient’s heart failure status (wherein heart sounds are stated as a potential sources of information relating to a person's heart failure status).) […]
Therefore, it would have been obvious for one of ordinary skill in the art of devices and methods for monitoring patients with a history of cardiac diseases at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of: Ni; Halperin; Derchak; and Dehkordi, to incorporate a step and feature directed to placing a local acceleration sensor on a left side of the chest at a region of cardiac point of maximal impact (PMI), as taught by Siejko, in order to obtain information that is known to help in diagnosing a patient’s heart failure status. See Siejko, p.336, Col. 2, lines 7-15 (wherein heart sounds are stated as a potential sources of information relating to a person's heart failure status); see also MPEP § 2143 G.
- Yet still further, the combination of: An, as modified in view of: Ni; Halperin; Derchak; Dehkordi; and Siejko, does not explicitly teach, however, in analogous art of systems and methods for monitoring and predicting progression of diseases in patients, Lee et al. (Pub. No. US 2005/0074741) teaches:
- a local accelerometer placed on a upper abdomen (epigastrium) near a diaphragm of the patient (Lee, paragraphs [0003]-[0008], [0043], and [0066]; Paragraph [0043] teaches that the EMG sensor may be positioned internally or externally to detect electrical activity of a patient's intercostal, pectoral and/or diaphragmatic muscles (i.e., a local accelerometer is placed on or near the diaphragm of the patient) indicative of motion, and paragraph [0066] teaches that the accelerometer 440 senses patient motion associated with respiratory effort, e.g. motion of the chest wall, abdomen diaphragm (i.e., a local accelerometer is placed on the upper abdomen/near the diaphragm of the patient), and/or thorax. Paragraphs [0003]-[0008] in Lee et al. (Pub. No. US 2005/0074741) teaches that this feature is beneficial for helping in diagnosing the different types of disordered breathing diseases, and subsequently helping to provide opportunities for more effective therapy (where classification of disordered breathing by their origin, e.g., “central, obstructive, or mixed” is known to enhance diagnoses of disordered breathing diseases such as Cheyne-Stokes respiration (CSR), or more commonly, central sleep apnea.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for monitoring and predicting progression of diseases in patients at the time of the effective filing date of the claimed invention to further modify the heart failure risk stratification and detection system and method taught by An, as modified in view of: Ni; Halperin; Derchak; Dehkordi; and Siejko, to incorporate a step and feature directed to placing a local acceleration sensor on a upper abdomen (epigastrium) near a diaphragm of the patient, as taught by Lee, in order to help in diagnosing the different types of disordered breathing diseases, and subsequently helps to provide opportunities for more effective therapy. For example, this motivation is described in Lee et al. (Pub. No. US 2005/0074741), where classification of disordered breathing by their origin, e.g., “central, obstructive, or mixed” is known to enhance diagnoses of disordered breathing diseases such as Cheyne-Stokes respiration (CSR), or more commonly, central sleep apnea. See Lee, paragraphs [0003]-[0008]; see also MPEP § 2143 G.
Conclusion
This is a continuation of applicant's earlier Application Nos. 15/121,77. All claims are drawn to the same invention claimed in the earlier applications and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier applications. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686