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 .
Response to Amendment
This Office Action is responsive to the Amendment and Supplemental Amendment filed on 24 December 2025. As directed by the amendment: Claims 1, 6, 12, 13, 14, 16, and 19 have been amended, Claims 5 and 17 have been cancelled, and Claim 21 has been added. Thus, Claims 1-4, 6-16, and 18-21 are presently pending in this application.
Claim Objections
Claim 21 is objected to because of the following informalities: the claim does not end in a period (.). Appropriate correction is required.
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 1-4, 6-16, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is a summary of the subject matter eligibility analysis:
Step 1:
Claims 1-4, 6-16, and 18-20 are directed to a method for determining vital signs of a subject (process). Thus, they are directed to one of the four statutory categories of invention.
Step 2A, prong 1:
Claim 1 recites the following limitations:
sensing movements of the skin of one or more regions of the subject and generating sensing data for each region
analyzing the sensing data and generating a variation profile for sensing data of each region
identifying, in each of the variation profiles, one or more predetermined electrical signal signatures indicative of at least one physiological event of the subject
extracting time stamps of the one or more identified predetermined electrical signal signatures
generating vital sign data indicative of at least one vital sign of the subject based on the extracted time stamps
Claim 16 recites a nearly identical method with some additional analysis details.
These limitations, under their broadest reasonable interpretations, recite performing mathematical calculations (processing and mathematically analyzing the data) and forming mathematical relationships (a relationship/correlation between measured signals and vital sign data), and as such, the claims recite limitations which may also fall within the 'mathematical concepts' grouping of abstract ideas. See MPEP 2106.4(a)(2). ‘‘[A] scientific truth, or the mathematical expression of it, is not patentable invention[.]’’ See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at 674; Flook, 437 U.S. at 589, 198 USPQ2d at 197; Mackay Radio & Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86, 94, 40 USPQ 199, 202 (1939).
Furthermore, the performed steps as drafted in Claims 1 and 16, under the broadest reasonable interpretation, is merely a mental process than can be performed by a person mentally and/or using a pen and paper, because these are steps are akin to having a doctor or other human actor performing a diagnosis based on data and mathematically evaluating sensed/input data, and then providing output (e.g. calculating, diagnosing, determining vital signs, etc.) based on the data. Therefore, these steps may be performed mentally by a human actor and implemented by selecting output or performing calculations based on the evaluation mentally or by hand using a pen and paper, such as a doctor performing a diagnosis based on analyzing signal data. Accordingly, the “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (such as ‘vital sign data’ of the signal as claimed). Therefore, if claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Dependent Claims 2-4, 6-15, and 18-20 recite providing output such as vital sign data. However, these are steps are akin to having a doctor or other human actor performing a diagnosis based on data and mathematically evaluating sensed/input data, and then providing output (e.g. providing/outputting analyzed data, etc.) based on the data. Therefore under their broadest reasonable interpretation, these claims cover the performance of the limitations within the human mind or by a human using a pen and paper.
Dependent Claims 2-4, 6-15, and 18-20 merely recite additional processing and analyzing steps or pre-solution data gathering with generic and well-known components, and therefore are also considered to cover concepts that are performing mathematical calculations and forming mathematical relationships, and may be considered mental processes as defined in MPEP 2106.04(a) and MPEP 2106.04(b).
Step 2A, prong 2:
Claims 15-28 recite the following additional limitations:
sensing movements of the skin
pressure sensors comprising a piezoelectric component and a capacitor component
placing sensors below the head of the subject
The judicial exception is not integrated into a practical application.
These elements merely use generic computer and sensing components to evaluate a sensed signal and provide generic data “output”. It is noted that no direct therapy or treatment initiation is explicitly claimed. Recording a biological signal with sensors (including pressure sensors proximal to the skin/head) of a mammal is a well-known and conventional technique that uses some type of generic pressure sensors to record data from a mammal. This analysis includes merely acquiring a signal/data from a user using a generic pressure sensors and is considered an insignificant pre-solution activity of gathering data for use in a claimed process (see MPEP 2106.05(g)). This pre-solution activity of data gathering and then performing calculations/analyses is well-known and typical in the field of medical sensing and computing technology.
Additionally, “analyzing”, “identifying”, and “extracting” steps as claims are considered a well-known techniques in the field, with known computing elements being programmed to process information and identify/classify metrics being a concept used to process physiological signals. Further, these limitations comprise processing the signals data to estimate an analysis. These limitations amount to mere instructions to apply an exception (MPEP 2106.05(f)), wherein the exception is a natural phenomena where a correlation between pressure sensing/biological data exists and computer components merely implement a set of instructions to “apply”/find the exception. As found in MPEP 2106.05(f), “the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”.”
Outputting analyzed information based on sensed signal data is a well-known and typical limitation. In the medical field, the ability to output/generate analyzed signal data to a clinician is a well-established activity. For example, see Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000, previously cited) which describes known biological signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis. Furthermore, the previously cited Mack et al. (US Publication No. 2008/0275314) and Ozaki et al. (US Publication No. 2005/0107722) references described in detail below discloses known sensing systems that analyze sensed biological signals and present data.
Therefore, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The limitations of acquiring a signal/data from a user using generic pressure sensors is considered an insignificant pre-solution activity of gathering data for use in a claimed process. The limitations of “generating vital sign data” as recited in independent Claims 1 and 16 amount to no more than extra-solution activity and thus does not provide significantly more.
Dependent Claims 2-4, 6-15, and 18-20 merely recite additional processing and analyzing steps or pre-solution data gathering with generic and well-known components, and merely recite additional processing and analyzing steps, and therefore are also considered to not be integrated into a practical application for the same reasons as Claims 1 and 16.
By the above reasoning, none of the above amount to integrating the mathematical concepts or mental processes into practical application.
Step 2B :
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed with respect to Step 2A - Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using generic computer/senor components. The same analysis applies here in 2B and does not provide an eligible inventive concept.
The data gathering (for example, receiving sensed signals) Claims 1 and 16 amounts to no more than mere pre-solution activity of data processing, and this pre-solution activity of processing data using known sensors is well-understood, routine, and conventional in the field of computing and medical technology. Furthermore, the only structural elements provided in the claims are “pressure sensors”. These are well-understood, routine, and conventional systems in the field of computing and medical technology, as evidenced by the previously cited Mack et al. (US Publication No. 2008/0275314), Ozaki et al. (US Publication No. 2005/0107722), and Ortiz et al. (US Publication No. 2009/0192534) references described in detail below. Additionally, see Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000, previously cited) which describes well-known and conventional signal sensing elements and computer processing elements (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis.
Further, dependent Claims 2-4, 6-15, and 18-20 are rejected on the same grounds as Claims 1 and 16. These dependent claims do not add significantly more to the judicial exceptions and merely recite additional analysis/mathematical steps and generic output. Therefore, the evaluations steps of Claims 1-4, 6-16, and 18-20 do not recite any additional structural elements or limitations on practical applications (e.g. specific treatment). The limitations in Claims 1 and 16 of “generating vital sign data” fails to provide any specific treatment or action to a patient, and is merely outputting a result which is considered generic output. Thus, the claims are not patent eligible.
Therefore, Claims 1-4, 6-16, and 18-20 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more. It is recommended by the Examiner that explicit tangible output or treatment/therapy steps based on the analysis, or explicit non-generic structure, be added to independent Claims 1 and 16 in order to overcome the rejections under 35 U.S.C. 101. It is noted that any amendment must be fully supported by the Specification/Drawings as originally filed.
It is further noted that new Claim 21 recites additional claimed limitations including “a plurality of pressure sensors are arranged to sense micron-sized scale skin movements associated with a common internal physiological event” and “a control unit is configured to fuse pressure measurements from the sensors into an n-dimensional signal curve, generate a pressure variation profile defined by a Euclidean or affine curvature invariant of the signal curve, identify a predetermined curvature- based signature corresponding to the physiological event, extract a time stamp of the signature, and determine the vital sign based on a temporal relation between extracted time stamps”, which include steps that are not merely a mental process, and these steps may not be practically performed in the human mind, and additional include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, Claim 21 is patent-eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 21, the claim recites the limitation "the variation composite profile" in Line 6. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear as to what is intended by a “composite profile” since this limitation is not explicitly defined within the claims nor the Specification. Therefore this limitation is indefinite. For purposes of examination, this term will be interpreted simply as “the variation profile” as recited in Claims 1 and 16. Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-11, 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mack et al. (US Publication No. 2008/0275314, previously cited) in view of Ozaki et al. (US Publication No. 2005/0107722, previously cited).
Regarding Claims 1, 6, 14, and 16, Mack et al. discloses a method for determining vital signs of a subject (Abstract), the method comprising the steps of:
sensing movements of the skin of one or more regions of the subject and generating sensing data for each region (sensors detecting micromovements and skin parameters, Paragraph 0012-0013, 0033, 0037, 0045, 0054; see configurations of Figs. 3, 5, 6);
the sensing data comprising a plurality of measured signals each indicative of a common physiological event differentiated in time and intensity from one another (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0079, 0081; pressure variation graphical representations, Figs. 12B-12D, 13A-B);
analyzing the sensing data (Paragraph 0033, 0045, 0092) and generating a pressure variation profile for sensing data of each region (pressure variation graphical representations, Figs. 12B-12D, 13A-B; Paragraph 0047-0048, 0091-0096);
identifying, in each of the pressure variation profiles, one or more predetermined electrical signal signatures indicative of at least one physiological event of the subject (determining peaks/levels of sensed pressure and other physiological data, which indicate different conditions of the patient based on the pressure profiles, Figs. 12B-12D, 13A-B; Paragraph 0045, 0051, 0091-0096; Abstract);
extracting time stamps of the one or more identified predetermined electrical signal signatures (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0079, 0081);
and generating vital sign data indicative of at least one vital sign of the subject (Paragraph 0042, 0045, 0076, 0079-0080; various physiological parameters/vital sign data, Fig. 14) from the predetermined electrical signal signatures based on the extracted time stamps (Paragraph 0038, 0042, 0076, 0079, 0081).
Mack et al. further discloses that the sensors are arranged in arrays and generates multidimensional pressure data of a region (sensors 210 and 220 arranged in arrays for sensing different areas of the body, Fig. 2; Paragraph 0033, 0047-0048, 0051, 0053, 0074, 0087-0088), wherein sensing comprises sensing from two or more sub-regions in each region (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053). However, Mack et al. does not explicitly disclose wherein the variation profile is a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, wherein the one or more predetermined electrical signal signatures is characterized by a threshold of at least one projection of the curve.
Ozaki et al. teaches a system and method for determining at least one vital sign of a subject (Abstract; Paragraph 0005-0007) comprising a plurality of pressure sensors configured to be placed in a vicinity of the subject's body in an array (Paragraph 0008, 0010, 0011) and generating sensing data comprising a plurality of measured signals being indicative of a common physiological event differentiated in time and intensity from one another (Abstract, Paragraph 0008, 0040; Claim 1), and wherein a pressure variation profile is a single curvature of an n-dimensional curve (generating curve/profile data of the plurality of pressure sensors, Paragraph 0008, 0010, 0011, 0031-0032), wherein "n" is the number of sensors associated with the same region corresponding to the number of sub-regions in each region (plurality of pressure sensors corresponding to data curve profiles, Paragraph 0008, 0010, 0011, 0031-0032, 0063-0064, 0069; see Figs. 9-10), and wherein the predetermined electrical signal signature is characterized by a threshold of at least one projection of the curve (threshold values, Paragraph 0054, 0062-0064).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the variation profile to be a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, and to configure the predetermined electrical signal signature to be characterized by a threshold of at least one projection of the curve, as taught by Ozaki et al., in the method for determining at least one vital sign of a subject as disclosed by Mack et al., in order to obtain multidimensional data based on the pressure sensors to accurately determine abnormalities or variances in body position/movement, and thereby to more accurately diagnose medical conditions for prompt treatment, as also taught by Ozaki et al. (Paragraph 0006, 0040, 0086-0088).
Regarding Claims 2 and 3, Mack et al. discloses the method further wherein generating vital sign data comprises determining time relation between different time stamps (determining data over time, including timed logs with at least first and second timestamps, Paragraph 0038, 0042, 0076, 0079, 0081), and wherein the relation between different time stamps comprises a time difference between time stamps (physiological conditions over progression of time, Paragraph 0038, 0042, 0045, 0076, 0079-0081).
Regarding Claim 4, Mack et al. discloses the method further wherein sensing comprises sensing from two or more sub-regions in each region (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053).
Regarding Claim 7, Mack et al. discloses the method further wherein the sensing data comprises intensities of pressure samples sensed in each region over time (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053).
Regarding Claims 8 and 9, Mack et al. discloses the method further wherein at least one region comprises the head of the subject (head over sensors, Fig. 3; sensors within pillow, Paragraph 0033, 0055, 0059), or wherein at least one region comprises the chest of the subject and at least one region comprises the abdomen of the subject (chest, back, or abdomen regions for sensors, see Fig. 3, 6; Paragraph 0048, 0050, 0051, 0063, 0090-0091).
Regarding Claims 10, 11, and 18, Mack et al. discloses the method further comprising receiving electrical signal data of the subject such as an ECG of the subject (EKG, Paragraph 0029, 0092, Fig. 12A), wherein an ECG measurement device to provide said electrical signal data (EKG, Paragraph 0029, 0092, Fig. 12A); extracting time stamps of physiological events from the electrical signal data (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0092); and generating vital sign data indicative of at least one vital sign of the subject (Paragraph 0042, 0045, 0076, 0079-0080; various physiological parameters/vital sign data, Fig. 14) based on a relation between time stamps extracted from the electrical signal data and time stamps extracted from the one or more identified predetermined electrical signal signatures of the pressure variation profile (determining data over time, including timed logs with timestamps for determination of conditions, Paragraph 0038, 0042, 0076, 0092).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mack et al. (US Publication No. 2008/0275314, previously cited) in view of Ozaki et al. (US Publication No. 2005/0107722, previously cited), further in view of Ortiz et al. (US Publication No. 2009/0192534, previously cited).
Regarding Claim 12, Mack et al. further discloses wherein sensing movements is performed by pressure sensors which comprise a piezoelectric component (piezoelectric sensors, Paragraph 0033, 0037, 0051, 0063, 0071, 0087, 0091, 0095) configured to sense at relatively fast sampling rates (adequate sampling rates, which would include “relatively fast” signals, Paragraph 0038, 0040, 0062, 0069), and that the sensors may comprise a resistance/capacitance timing circuit (Paragraph 0037). However, Mack et al. does not explicitly disclose wherein the sensors include a capacitor component which is configured to sense at relatively slow sampling rates.
Ortiz et al. teaches a system and method for determining at least one vital sign of a subject (Abstract) comprising pressure sensors, wherein the sensors include a capacitor component (Paragraph 0047, 0052) which is configured to sense at relatively slow sampling rates (capacitor/sensor components use low sampling frequencies, Paragraph 0052, 0057). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensors in the method disclosed by Mack et al. and Ozaki et al. in combination to include a capacitor component which is configured to sense at relatively slow sampling rates as taught by Ortiz et al., in order to conserve power based on the operational needs of the system, as also taught by Ortiz et al. (Paragraph 0052).
Claims 13, 15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mack et al. (US Publication No. 2008/0275314, previously cited) in view of Ozaki et al. (US Publication No. 2005/0107722, previously cited), further in view of Mourad et al. (US Publication No. 2005/0015009, previously cited).
Regarding Claims 13 and 19, Mack et al. further discloses wherein placing sensors placed below the head of the subject (head over sensors, Fig. 3; sensors within pillow, Paragraph 0033, 0055, 0059) to identify curvature peaks related to heart cycle (Paragraph 0029, 0092). However, Mack et al. does not explicitly disclose wherein the sensors also identify pulse reflection inside the skull, and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively.
Mourad et al. teaches a method for determining vital signs of a subject (Abstract, Paragraph 0037-0039) comprising pressure sensors (Paragraph 0004-0005, 0027; Claims, 1, 2, 10), wherein the sensors identify pulse reflection inside the skull (skull of Figs. 6A-6B; Paragraph 0027, 0029, 0190, 0192, 0254), and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively (Abstract, Paragraph 0037-0041, 0057, 0255; Claims 1-2, 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensors in the method disclosed by Mack et al. and Ozaki et al. in combination to also identify pulse reflection inside the skull, and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively, as taught by Mourad et al., in order to monitor intracranial pressure of a patient, since this is an important diagnostic in determining brain health and physical trauma, as also taught by Mourad et al. (Paragraph 0010-0011).
Regarding Claims 15 and 20, Mack et al. further discloses extracting time stamps of physiological events from the electrical signal data (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0092); and generating vital sign data indicative of at least one vital sign of the subject (Paragraph 0042, 0045, 0076, 0079-0080; various physiological parameters/vital sign data, Fig. 14) based on a relation between time stamps extracted from the electrical signal data and time stamps extracted from the one or more predetermined signatures of the variation profile (determining data over time, including timed logs with timestamps for determination of conditions, Paragraph 0038, 0042, 0076, 0092), and particularly wherein electrical signal signatures may be stored in memory (Paragraph 0042-0045, 0052, 0061).
However, Mack et al. does not disclose wherein the one or more predetermined electrical signal signatures are preselected signatures stored in a learning database. Mourad et al. teaches a method for determining vital signs of a subject (Abstract, Paragraph 0037-0039) comprising pressure sensors (Paragraph 0004-0005), wherein one or more predetermined electrical signal signatures are preselected signatures stored in a learning database for determination of the physiological parameters (machine learning based on adaptive models of signal signatures, Paragraph 0117, 0124-0128, 0131-0137, 0144-0145, 0155-0157). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to store the preselected signatures in a learning database as taught by Mourad et al. in the method disclosed by Mack et al. and Ozaki et al. in combination, in order to efficiently and adaptively predict particular physiological profiles of the sensed signals in order to better provide more accurate and faster diagnoses/results, as also taught by Mourad et al. (Paragraph 0112-0115, 0150, 0170).
Allowable Subject Matter
Claim 21 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) and Claim Objection set forth above in this Office action.
None of previously cited Mack et al., Ozaki et al., Ortiz et al., nor Mourad et al. discloses or teaches all of the claimed limitations of new Claim 21, particularly including the steps of sensing movements of the skin of one or more regions of the subject and generating sensing data for each region; analyzing the sensing data and generating a variation profile for sensing data of each region, wherein the variation composite profile is a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, including wherein a plurality of pressure sensors are arranged to sense micron-sized scale skin movements associated with a common internal physiological event and a control unit is configured to fuse pressure measurements from the sensors into an n- dimensional signal curve, generate a pressure variation profile defined by a Euclidean or affine curvature invariant of the signal curve, identify a predetermined curvature- based signature corresponding to the physiological event, extract a time stamp of the signature, and determine the vital sign based on a temporal relation between extracted time stamps. Therefore, Claim 21 would be allowable over the prior art if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) and Claim Objection set forth above in this Office action.
Response to Arguments
The previous 35 U.S.C. 112(b)/pre-AIA second paragraph rejections have been withdrawn due to the Applicant’s amendments to Claims 1, 6, 12, 13, 14, 16, and 19 as filed in the Amendment/Response filed 24 December 2025. However, new 35 U.S.C. 112(b) rejections and Claim Objections have also been made above due to new Claim 21.
35 U.S.C. 101
As described in detail above, Claims 1-4, 6-16, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. It is recommended by the Examiner that explicit tangible output or treatment/therapy steps based on the analysis, or explicit non-generic structure, be added to independent Claims 1 and 16 in order to overcome the rejections under 35 USC 101. It is noted that any amendment must be fully supported by the Specification/Drawings as originally filed.
It is further noted that new Claim 21 recites additional claimed limitations including “a plurality of pressure sensors are arranged to sense micron-sized scale skin movements associated with a common internal physiological event” and “a control unit is configured to fuse pressure measurements from the sensors into an n-dimensional signal curve, generate a pressure variation profile defined by a Euclidean or affine curvature invariant of the signal curve, identify a predetermined curvature- based signature corresponding to the physiological event, extract a time stamp of the signature, and determine the vital sign based on a temporal relation between extracted time stamps”, which include steps that are not merely a mental process, and these steps may not be practically performed in the human mind, and additional include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, Claim 21 is patent-eligible under 35 U.S.C. 101.
With respect to the 35 U.S.C. 101 rejections of Claims 1-4, 6-16, and 18-20, the Applicant initially argues (Page 8 of Amendment/Response):
A. The Claims Are Rooted in Physical Signal Acquisition and Processing
Independent Claims 1 and 16 recite physically sensing movements of the skin of a subject using pressure sensors, generating sensing data for multiple regions, and processing that data through a defined signal-processing pipeline to generate vital sign data. These steps require physical interaction with a subject, generation of time-resolved sensing data, and extraction of signal-domain features therefrom.
However, the Examiner disagrees with these arguments. The steps recited in the claims merely use generic computer and sensing components to evaluate a sensed signal and provide generic data “output”. It is noted that no direct therapy or treatment initiation is explicitly claimed. Recording a biological signal with sensors (including pressure sensors proximal to the skin/head) of a mammal is a well-known and conventional technique that uses some type of generic pressure sensors to record data from a mammal. This analysis includes merely acquiring a signal/data from a user using a generic pressure sensors and is considered an insignificant pre-solution activity of gathering data for use in a claimed process (see MPEP 2106.05(g)). This pre-solution activity of data gathering and then performing calculations/analyses is well-known and typical in the field of medical sensing and computing technology.
The Applicant further argues (Pages 8-9 of Amendment/Response):
B. The Claims Recite a Technical Signal-Processing Pipeline, Not a Result
The Examiner characterizes the claims as merely "analyzing" and "identifying" data. However, the claims do not merely recite a desired outcome…
These steps define a specific transformation of raw sensor data into a different form suitable for physiological measurement. This is analogous to the claims held eligible in McRO,Inc. v. Bandai Namco Games America Inc., where specific rules applied to data processing rendered the claims patent eligible.
However, the Examiner disagrees with these arguments. The “analyzing”, “identifying”, and “extracting” steps as claims are considered a well-known techniques in the field, with known computing elements being programmed to process information and identify/classify metrics being a concept used to process physiological signals. Further, these limitations comprise processing the signals data to estimate an analysis. These limitations amount to mere instructions to apply an exception (MPEP 2106.05(f)), wherein the exception is a natural phenomena where a correlation between pressure sensing/biological data exists and computer components merely implement a set of instructions to “apply”/find the exception. As found in MPEP 2106.05(f), “the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”.”
Outputting analyzed information based on sensed signal data is a well-known and typical limitation. In the medical field, the ability to output/generate analyzed signal data to a clinician is a well-established activity. For example, see Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000, previously cited) which describes known biological signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis. Furthermore, the previously cited Mack et al. (US Publication No. 2008/0275314) and Ozaki et al. (US Publication No. 2005/0107722) references described in detail above discloses known sensing systems that analyze sensed biological signals and present data.
The Applicant further argues (Page 9 of Amendment/Response):
C. The Sensing Limitations Are Not Insignificant Pre-Solution Activity
The Examiner asserts that sensing movements of the skin using pressure sensors constitutes insignificant pre-solution data gathering. Applicant respectfully disagrees. The manner in which the physiological signal is physically acquired- including sensing skin movement from defined regions using pressure sensors- directly impacts the generated variation profiles and extracted time stamps.
These sensing limitations are integral to the claimed invention and are not merely appended data-gathering steps.
Under MPEP §2106.05(g), data gathering is not insignificant where, as here, it is part of the claimed technical solution and is necessary for the subsequent processing steps to function as claimed.
However, the Examiner disagrees with these arguments. As stated above, the steps recited in the claims merely use generic computer and sensing components to evaluate a sensed signal and provide generic data “output”. It is noted that no direct therapy or treatment initiation is explicitly claimed. Recording a biological signal with sensors (including pressure sensors proximal to the skin/head) of a mammal is a well-known and conventional technique that uses some type of generic pressure sensors to record data from a mammal. This analysis includes merely acquiring a signal/data from a user using a generic pressure sensors and is considered an insignificant pre-solution activity of gathering data for use in a claimed process (see MPEP 2106.05(g)). This pre-solution activity of data gathering and then performing calculations/analyses is well-known and typical in the field of medical sensing and computing technology.
The Applicant further argues (Page 9 of Amendment/Response):
D. Generating Vital Sign Data Is Not a Diagnosis or Mental Judgment
The Examiner equates generating vital sign data with diagnosis or mental evaluation. However, generating vital sign data is a measurement output, not a medical judgment or treatment decision. The claims do not recite diagnosing a condition, prescribing treatment, or making a clinical judgment. Rather, the claims produce physiological measurements from sensed signals, which is a technical operation analogous to heart rate or respiration rate measurement systems found eligible by the Federal Circuit (see, e.g., CardioNet, LLC v. InfoBionic, Inc.).
However, the Examiner disagrees with these arguments. The limitations of Claims 1 and 16, under their broadest reasonable interpretations, recite performing mathematical calculations (processing and mathematically analyzing the data) and forming mathematical relationships (a relationship/correlation between measured signals and vital sign data), and as such, the claims recite limitations which may also fall within the 'mathematical concepts' grouping of abstract ideas. See MPEP 2106.4(a)(2). ‘‘[A] scientific truth, or the mathematical expression of it, is not patentable invention[.]’’ See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at 674; Flook, 437 U.S. at 589, 198 USPQ2d at 197; Mackay Radio & Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86, 94, 40 USPQ 199, 202 (1939). Furthermore, the performed steps as drafted in Claims 1 and 16, under the broadest reasonable interpretation, is merely a mental process than can be performed by a person mentally and/or using a pen and paper, because these are steps are akin to having a doctor or other human actor performing a diagnosis based on data and mathematically evaluating sensed/input data, and then providing output (e.g. calculating, diagnosing, determining vital signs, etc.) based on the data. Therefore, these steps may be performed mentally by a human actor and implemented by selecting output or performing calculations based on the evaluation mentally or by hand using a pen and paper, such as a doctor performing a diagnosis based on analyzing signal data. Accordingly, the “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (such as ‘vital sign data’ of the signal as claimed). Therefore, if claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
The Applicant further argues (Page 10 of Amendment/Response):
Step 2B - Inventive Concept (Not Reached)
Notwithstanding the foregoing, and without conceding that Step 2B is properly reached, the claims recite additional elements-including physical pressure sensors, region-specific sensing, and defined signal processing-that, in combination, are not well-understood, routine, or conventional when considered as an ordered combination. Accordingly, the claims also recite significantly more than any alleged judicial exception.
However, the Examiner disagrees with these arguments. As discussed with respect to Step 2A - Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using generic computer/senor components. The same analysis applies here in 2B and does not provide an eligible inventive concept. The data gathering (for example, receiving sensed signals) Claims 1 and 16 amounts to no more than mere pre-solution activity of data processing, and this pre-solution activity of processing data using known sensors is well-understood, routine, and conventional in the field of computing and medical technology. Furthermore, the only structural elements provided in the claims are “pressure sensors”. These are well-understood, routine, and conventional systems in the field of computing and medical technology, as evidenced by the previously cited Mack et al. (US Publication No. 2008/0275314), Ozaki et al. (US Publication No. 2005/0107722), and Ortiz et al. (US Publication No. 2009/0192534) references described in detail below. Additionally, see Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000, previously cited) which describes well-known and conventional signal sensing elements and computer processing elements (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis.
35 U.S.C. 103 – Independent Claims 1 and 16
The Applicant's arguments filed in the Amendment/Response filed 24 December 2026 with respect to the previous 35 U.S.C. 103 rejections of Claims 1-4, 6-16, and 18-20 have been fully considered.
Firstly, in response to the Applicant's arguments against the references individually with respect to independent Claims 1 and 16 (Pages 12-13 of Amendment/Response, “Mack and Ozaki Solve Different Technical Problems”), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, in response to the Applicant’s arguments (Pages 13-14 of Amendment/Response) that there is no teaching, suggestion, or motivation to combine the Mack et al. and Ozaki et al. references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner maintains that Mack et al. further discloses that the sensors are arranged in arrays and generates multidimensional pressure data of a region (sensors 210 and 220 arranged in arrays for sensing different areas of the body, Fig. 2; Paragraph 0033, 0047-0048, 0051, 0053, 0074, 0087-0088), wherein sensing comprises sensing from two or more sub-regions in each region (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053).
Furthermore, the Examiner maintains that Mack et al. does disclose analyzing the sensing data (Paragraph 0033, 0045, 0092) and generating a pressure variation profile for sensing data of each region (pressure variation graphical representations, Figs. 12B-12D, 13A-B; Paragraph 0047-0048, 0091-0096); and identifying, in each of the pressure variation profiles, one or more predetermined electrical signal signatures indicative of at least one physiological event of the subject (determining peaks/levels of sensed pressure and other physiological data, which indicate different conditions of the patient, Figs. 12B-12D, 13A-B; Paragraph 0045, 0051, 0091-0096; Abstract), and extracting time stamps of the one or more identified predetermined signatures (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0079, 0081).
In particular, Mack et al. discloses (Paragraph 0045):
In the analysis module 150 information derived from each of the sensors may be interpreted to provide indications of the state of various physiological characteristics. These include, but are not limited to heart rate, HRV, blood pressure, respiratory rate and regularity, apneas and hypopneas, body surface temperature at multiple points, restlessness or activity levels, body position, as well as detailed movement information and pressure points. By way of example, skin temperature and/or pulse magnitude may be measured at the extremities, such as the lower leg or foot, and compared to the measurements of the upper body or torso to calculate a peripheral vascular resistance (PVR). PVR is a characteristic linked to the detection of cardiovascular disease. These results can be displayed through visual feedback, such as a monitor located remotely or at the apparatus itself, and/or as a summary report or graph on a personal computer.
Mack et al. also discloses (Paragraph 0051):
…one or more sensor pads 220 may extend transversely across the width of and are placed on the mattress 200. As described above, the sensor pads 220 may include ultra-sensitive vibration sensors, such as piezoelectric, fiber optic, or load cell based sensors that provide data, which may be input into the system at 120, and sensitive enough to provide through signal processing techniques, waveforms of heart rate, HRV, breathing rate, snoring and other physiological characteristics as described above. The vibration sensor pad 220 may be a foam pad with sensors embedded therein. Alternatively, the sensor pad 220 may be filled with air. The vibration sensor pads 220 may be placed at chest level (e.g., the rib cage) and abdomen level (e.g., below the rib cage), to provide readings of signals for heart rate and breathing. In addition, it may be desirable to have a vibration sensor pad 220 at leg level (e.g., calves) to read signals for heart rate.
Mack et al. also shows the identifying, in each of the pressure variation profiles, one or more predetermined electrical signal signatures indicative of at least one physiological event of the subject, and extracting time stamps of the one or more identified predetermined electrical signal signatures, as show in Figs. 12A-D reproduced below, and in particular Mack et al. discloses (Paragraph 0091-0092, emphasis added):
FIGS. 12B, 12C and 12D are sample waveforms obtained from a system for non-invasive analysis of physiological signals constructed according to the principles of the invention. A vibration pad sensor, such as vibration pad sensors 220 in FIG. 2, was placed at chest level on a subject and another vibration pad sensor was placed at abdomen level of the subject. The vibration pad sensors were foam pads with tubing at one end and a piezoelectric sensor at the other end of the tubing. The data from the vibration pad sensor was processed through a circuit similar to circuit 800 in FIG. 8.
FIG. 12A is an EKG waveform taken of the subject during the same time of the measurements that resulted in the sample waveforms of FIGS. 12B, 12C and 12D of the invention. FIG. 12B is a sample upper chest pulse waveform. FIG. 12C is a sample abdomen pulse waveform. The chest and abdomen pulse waveforms are compared to each other in an algorithm, such as that described in FIG. 14, so that if for some reason there is noise in one set, the other can be used. If both waveforms are good, they are compared to provide a more accurate assessment of heart rate. Ultimately, the best waveform is selected out of numerous processing techniques, so it provides added redundancy and reliability to enhance the accuracy and precision of the sensor. The "3rd of 10 pictured" systolic peak in FIGS. 12A, 1213, 12C refers to the fact that all three heart rate waveforms are displaying the same data set, meaning that the labeled peak is the same heartbeat in each of the figures, i.e., the waveforms represent the same data. Thus, the heart rate waveforms of the invention have comparable accuracy to that of conventional EKG readings.
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Thus Mack et al. discloses generating vital sign data comprises determining time relation between different time stamps (determining data over time, including timed logs with at least first and second timestamps, Paragraph 0038, 0042, 0076, 0079, 0081), and wherein the relation between different time stamps comprises a time difference between time stamps (physiological conditions over progression of time, Paragraph 0038, 0042, 0045, 0076, 0079-0081). As can be seen in the graphs above, Mack et al. discloses generating vital sign data comprises determining time relation between different time stamps, since the time differential is explicitly shown in the charts of Figs. 12B-12D.
However, the Examiner agrees that Mack et al. does not explicitly disclose wherein the variation profile is a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, wherein the one or more predetermined electrical signal signatures is characterized by a threshold of at least one projection of the curve. Therefore, Ozaki et al. was used to teach this limitation. As described above, Ozaki et al. teaches a system and method for determining at least one vital sign of a subject (Abstract; Paragraph 0005-0007) comprising a plurality of pressure sensors configured to be placed in a vicinity of the subject's body in an array (Paragraph 0008, 0010, 0011) and generating sensing data comprising a plurality of measured signals being indicative of a common physiological event differentiated in time and intensity from one another (Abstract, Paragraph 0008, 0040; Claim 1), and wherein a pressure variation profile is a single curvature of an n-dimensional curve (generating curve/profile data of the plurality of pressure sensors, Paragraph 0008, 0010, 0011, 0031-0032), wherein "n" is the number of sensors associated with the same region corresponding to the number of sub-regions in each region (plurality of pressure sensors corresponding to data curve profiles, Paragraph 0008, 0010, 0011, 0031-0032, 0063-0064, 0069; see Figs. 9-10), and wherein the predetermined electrical signal signature is characterized by a threshold of at least one projection of the curve (threshold values, Paragraph 0054, 0062-0064).
Therefore, the Examiner maintains that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the variation profile to be a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, and to configure the predetermined electrical signal signature to be characterized by a threshold of at least one projection of the curve, as taught by Ozaki et al., in the method for determining at least one vital sign of a subject as disclosed by Mack et al., in order to obtain multidimensional data based on the pressure sensors to accurately determine abnormalities or variances in body position/movement, and thereby to more accurately diagnose medical conditions for prompt treatment, as also taught by Ozaki et al. (Paragraph 0006, 0040, 0086-0088).
Thus, in response to the Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (see Page 13 of Amendment/Response), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
35 U.S.C. 103 – Dependent Claims
Claims 2 and 3
Regarding Claims 2 and 3, the Applicant argues that (Page 15 of Amendment/Response):
In the present claims, the timestamps are not generic logging times, but are event-specific timestamps extracted from identified electrical signal signatures obtained from curvature-based variation profiles. The claimed "time relation" and "time difference" therefore represent a derived physiological metric (e.g., propagation delay, pulse wave velocity, or reflection timing), not merely elapsed time between logged samples. Mack's disclosure of timed logs does not teach or suggest this functional use of time differences, nor does it link such time differences to signature-based physiological event extraction.
However, the Examiner disagrees with these arguments. Firstly, Mack et al. and Ozaki et al. in combination teach all of the claims elements of independent Claim 1 as described above. In response to the Applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which the Applicant relies (i.e., specific interpretations of "time relation" and "time difference") are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Mack et al. discloses the method further wherein generating vital sign data comprises determining time relation between different time stamps (determining data over time, including timed logs with at least first and second timestamps, Paragraph 0038, 0042, 0076, 0079, 0081), and wherein the relation between different time stamps comprises a time difference between time stamps (physiological conditions over progression of time, Paragraph 0038, 0042, 0045, 0076, 0079-0081). Therefore, the Examiner maintains that Mack et al. discloses these limitations of Claims 2 and 3.
Claim 4
Regarding Claim 4, the Applicant argues that (Page 16 of Amendment/Response):
While Mack discloses spatially separated sensors, Mack does not disclose or suggest defining sub-regions within a region for the purpose of generating an n-dimensional variation profile represented as a single curvature, as required by independent Claim 1 and incorporated into Claim 4.
In the present claims, sensing from multiple sub-regions is not merely spatial placement; it is a structural and analytical requirement that enables construction of a multidimensional curve whose curvature encodes a common physiological event across sub-regions. Mack's arrays collect independent pressure values but do not fuse sub- region data into a single curvature-based representation.
However, the Examiner disagrees with these arguments. Firstly, Mack et al. and Ozaki et al. in combination teach all of the claims elements of independent Claim 1 as described above. In response to the Applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which the Applicant relies (i.e., specific interpretations of “sensing from multiple sub-regions” and “enables construction of a multidimensional curve whose curvature encodes a common physiological event across sub-regions” ) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Mack et al. discloses the method further wherein sensing comprises sensing from two or more sub-regions in each region (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053). Therefore, the Examiner maintains that Mack et al. discloses these limitations of Claim 4.
Claim 7
Regarding Claim 7, the Applicant argues that (Page 16 of Amendment/Response):
Mack's disclosure of pressure intensities does not teach or suggest using such intensities as inputs to an n-dimensional curve whose curvature is analyzed to extract predetermined electrical signal signatures. The cited portions of Mack describe raw pressure measurements, not the claimed transformation of intensity data into a curvature-based analytical framework.
However, the Examiner disagrees with these arguments. Claim 7 only recites “wherein the sensing data comprises intensities of pressure samples sensed in each region over time”. Mack et al. discloses the method further wherein the sensing data comprises intensities of pressure samples sensed in each region over time (sensors 210 and 220 arranged in spaced-apart arrays for sensing different areas of the body, Fig. 2; Paragraph 0047-0048, 0051, 0053). As stated above, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 8 and 9
Regarding Claims 8 and 9, the Applicant argues that (Page 17 of Amendment/Response):
Although Mack discloses sensor placement near the head, chest, or abdomen, Mack does not disclose or suggest analyzing curvature-based variation profiles derived from multiple sub-regions within these anatomical regions or extracting predetermined electrical signal signatures therefrom.
Claims 8 and 9 are not directed merely to sensor placement, but to anatomically distinct regions used within the claimed curvature-based signal processing framework to derive vital signs. Mack's disclosure of placing sensors near body regions does not teach or suggest the claimed analytical use of region-specific curvature profiles.
However, the Examiner disagrees with these arguments. Firstly, Mack et al. and Ozaki et al. in combination teach all of the claims elements of independent Claim 1 as described above. Mack et al. further discloses the method further wherein at least one region comprises the head of the subject (head over sensors, Fig. 3; sensors within pillow, Paragraph 0033, 0055, 0059), or wherein at least one region comprises the chest of the subject and at least one region comprises the abdomen of the subject (chest, back, or abdomen regions for sensors, see Fig. 3, 6; Paragraph 0048, 0050, 0051, 0063, 0090-0091). As stated above, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 10, 11, and 18
Regarding Claims 10, 11, and 18, the Applicant argues that (Pages 17-18 of Amendment/Response):
Mack discloses acquiring ECG signals and associating them with time. However, Mack does not disclose or suggest generating vital sign data based on a relationship between (i) timestamps extracted from ECG-derived physiological events and (ii) timestamps extracted from predetermined electrical signal signatures identified from curvature-based pressure variation profiles, as expressly required by Claims 10 and 18.
The claimed invention requires cross-modal temporal correlation between two independently extracted event streams-one electrical and one mechanical-curvature- based. Mack's disclosure lacks extraction of electrical signal signatures from curvature profiles and lacks relational analysis between those signatures and ECG-derived events.
Claim 11 further specifies the ECG as the electrical signal source, which Mack discloses only in isolation, not in the claimed integrated analytical relationship.
However, the Examiner disagrees with these arguments. Firstly, Mack et al. and Ozaki et al. in combination teach all of the claims elements of independent Claims 1 and 16 as described above. Mack et al. further discloses the method further comprising receiving electrical signal data of the subject such as an ECG of the subject (EKG, Paragraph 0029, 0092, Fig. 12A), wherein an ECG measurement device to provide said electrical signal data (EKG, Paragraph 0029, 0092, Fig. 12A); extracting time stamps of physiological events from the electrical signal data (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0092); and generating vital sign data indicative of at least one vital sign of the subject (Paragraph 0042, 0045, 0076, 0079-0080; various physiological parameters/vital sign data, Fig. 14) based on a relation between time stamps extracted from the electrical signal data and time stamps extracted from the one or more identified predetermined electrical signal signatures of the pressure variation profile (determining data over time, including timed logs with timestamps for determination of conditions, Paragraph 0038, 0042, 0076, 0092). In response to the Applicant's arguments that the references fail to show certain features of the invention, it is noted that the features upon which the Applicant relies (i.e., specific interpretations of “cross-modal temporal correlation between two independently extracted event streams-one electrical and one mechanical-curvature- based” and “analysis between those signatures and ECG-derived events” in view of “the integrated analytical relationship”) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 12
Regarding Claim 12, the Applicant argues that the “Office action relies on impermissible hindsight to combine these teachings” (Page 18 of Amendment/Response). However, in response to the Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As described above, Ortiz et al. teaches a system and method for determining at least one vital sign of a subject (Abstract) comprising pressure sensors, wherein the sensors include a capacitor component (Paragraph 0047, 0052) which is configured to sense at relatively slow sampling rates (capacitor/sensor components use low sampling frequencies, Paragraph 0052, 0057). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensors in the method disclosed by Mack et al. and Ozaki et al. in combination to include a capacitor component which is configured to sense at relatively slow sampling rates as taught by Ortiz et al., in order to conserve power based on the operational needs of the system, as also taught by Ortiz et al. (Paragraph 0052).
Claims 13 and 19
In response to the Applicant's arguments with respect to Claims 13 and 19 that, “The combination proposed by the Examiner lacks a teaching or suggestion to integrate Mourad's intracranial concepts with Mack's beneath-head sensing in the claimed analytical manner” (Pages 18-19 of Amendment/Response), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). With respect to Claims 13 and 19, Mack et al. further discloses wherein placing sensors placed below the head of the subject (head over sensors, Fig. 3; sensors within pillow, Paragraph 0033, 0055, 0059) to identify curvature peaks related to heart cycle (Paragraph 0029, 0092). However, Mack et al. does not explicitly disclose wherein the sensors also identify pulse reflection inside the skull, and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively. Mourad et al. was used to teach a method for determining vital signs of a subject (Abstract, Paragraph 0037-0039) comprising pressure sensors (Paragraph 0004-0005, 0027; Claims, 1, 2, 10), wherein the sensors identify pulse reflection inside the skull (skull of Figs. 6A-6B; Paragraph 0027, 0029, 0190, 0192, 0254), and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively (Abstract, Paragraph 0037-0041, 0057, 0255; Claims 1-2, 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the sensors in the method disclosed by Mack et al. and Ozaki et al. in combination to also identify pulse reflection inside the skull, and extracting reflection time which depends on pressure conditions inside the skull to monitor intracranial pressure changes non-invasively, as taught by Mourad et al., in order to monitor intracranial pressure of a patient, since this is an important diagnostic in determining brain health and physical trauma, as also taught by Mourad et al. (Paragraph 0010-0011). Therefore, the Examiner maintains that Claims 13 and 19 are unpatentable as obvious over Mack et al., Ozaki et al., and Mourad et al.
Claims 15 and 20
In response to the Applicant's arguments (Page 19 of Amendment/Response) with respect to Claims 15 and 20 that Mourad et al. fails to teach all of the claimed elements including “wherein the one or more predetermined electrical signal signatures are preselected signatures stored in a learning database”, the Examiner disagrees with these arguments. Firstly, Mack et al. and Ozaki et al. in combination teach all of the claims elements of independent Claims 1 and 16 as described above. Mack et al. further discloses extracting time stamps of physiological events from the electrical signal data (determining data over time, including timed logs with timestamps, Paragraph 0038, 0042, 0076, 0092); and generating vital sign data indicative of at least one vital sign of the subject (Paragraph 0042, 0045, 0076, 0079-0080; various physiological parameters/vital sign data, Fig. 14) based on a relation between time stamps extracted from the electrical signal data and time stamps extracted from the one or more predetermined signatures of the variation profile (determining data over time, including timed logs with timestamps for determination of conditions, Paragraph 0038, 0042, 0076, 0092), and particularly wherein electrical signal signatures may be stored in memory (Paragraph 0042-0045, 0052, 0061).
However, the Examiner agrees that Mack et al. does not disclose wherein the one or more predetermined electrical signal signatures are preselected signatures stored in a learning database. Mourad et al. teaches a method for determining vital signs of a subject (Abstract, Paragraph 0037-0039) comprising pressure sensors (Paragraph 0004-0005), wherein one or more predetermined electrical signal signatures are preselected signatures stored in a learning database for determination of the physiological parameters (machine learning based on adaptive models of signal signatures, Paragraph 0117, 0124-0128, 0131-0137, 0144-0145, 0155-0157). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to store the preselected signatures in a learning database as taught by Mourad et al. in the method disclosed by Mack et al. and Ozaki et al. in combination, in order to efficiently and adaptively predict particular physiological profiles of the sensed signals in order to better provide more accurate and faster diagnoses/results, as also taught by Mourad et al. (Paragraph 0112-0115, 0150, 0170).
Therefore, Claims 1-4, 6-16, and 19-20 are rejected as described in detail above.
Arguments with respect to New Claim 21
The Examiner agrees with the Applicant’s arguments (Pages 20-23 of Amendment/Response) with respect to new Claim 21. None of previously cited Mack et al., Ozaki et al., Ortiz et al., nor Mourad et al. discloses or teaches all of the claimed limitations of new Claim 21, particularly including the steps of sensing movements of the skin of one or more regions of the subject and generating sensing data for each region; analyzing the sensing data and generating a variation profile for sensing data of each region, wherein the variation composite profile is a single curvature of an n-dimensional curve, wherein 'n' is the number of sub-regions in each region, including wherein a plurality of pressure sensors are arranged to sense micron-sized scale skin movements associated with a common internal physiological event and a control unit is configured to fuse pressure measurements from the sensors into an n- dimensional signal curve, generate a pressure variation profile defined by a Euclidean or affine curvature invariant of the signal curve, identify a predetermined curvature- based signature corresponding to the physiological event, extract a time stamp of the signature, and determine the vital sign based on a temporal relation between extracted time stamps. Therefore, Claim 21 would be allowable over the prior art if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) and Claim Objection set forth above in this Office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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