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 .
Amendment Entered
In response to the amendment filed on December 12th, 2025, amended claims 1, 4, 7, and 9 are entered. Claims 2-3 and 5-6 are canceled.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim interpretations under 35 U.S.C. 112(f) have been fully considered but they are not persuasive. The claim interpretations are maintained in view of the amendment.
Although the claims do not recite “means” or “step”, the claim limitations still use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
With respect to the first prong of this analysis, the claim limitations use generic placeholders (a term that is simply a substitute for the term “means”) that do not limit the scope of the claim to any specific manner or structure for performing the claimed function. The term “unit” is a non-structural term, having no specific structural meaning for performing the claimed function. The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for.” See MPEP 2181.
With respect to the second prong of this analysis, the claims merely state the underlying function without recitation of structure for performing that function. It is clear that “unit” is set forth by the function it performs as opposed to the specific structure, material, or acts that perform the function.
With respect to the third prong of this analysis, the claim limitations are not modified by sufficient structure, material, or acts for achieving the specified function. In order to determine whether a word, term, or phrase coupled with a function denotes structure, (1) the specification must provide a description sufficient to inform one of ordinary skill in the art that the term denotes structure; (2) general and subject matter specific dictionaries provide evidence that the term has achieved recognition as a noun denoting structure; and (3) the prior art provides evidence that the term has an art-recognized structure to perform the claimed function. Ex parte Rodriguez, 92 USPQ2d 1395, 1404 (Bd. Pat. App. & Int. 2009) (precedential). There is no indication that “unit” denotes structure.
Applicant's remarks and amendments with respect to the rejection under 35 U.S.C. 112(a) have been fully considered. The rejection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on December 12th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pgs. 5-6 of the Reply, Applicant argues that under Step 2A, Prong 2 of the 2019 Patent Eligibility Guidance (PEG), claim 1 has been amended to more clearly recite that any abstract claim elements are integrated into a practical application. Applicant cites [0053-0056] of the Specification in order to provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing such improvements. Examiner respectfully disagrees.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). There is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
The processor, units, and medium perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements.
At Pg. 7 of the Reply, Applicant further argues that unlike Affinity Labs of Tex. v. DirecTV, LLC, the Applicant’s specification describes “multiple ways that the claimed invention provides technical improvements over the state of the art”. Examiner respectfully disagrees.
The disclosed “improvements” do not improve the functioning of the data acquisition or the signal exchange. “It is important to note, the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a). The data acquisition and signal exchange appear to perform the same with or without the abstract idea. Therefore, any improvement resides solely within the abstract idea.
Examiner further notes that even newly discovered abstract ideas are considered abstract. The Court recognized that “a novel and useful structure created with the aid of knowledge of scientific truth” might be patentable. Id., at 67 (quoting Mackay Radio, 306 U. S., at 94). But it held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle. For the mathematical formula had “no substantial practical application except in connection with a digital computer.” Benson, supra, at 71. Hence the claim (like the claims before us) was overly broad; it did not differ significantly from a claim that just said “apply the algorithm.” See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
At Pgs. 7-8 of the Reply, Applicant argues that under Step 2B of the 2019 Patent Eligibility Guidance (PEG), amended claim 1 amounts to significantly more than the abstract idea. Applicant cites [0047-0048] of the Specification in order to describe the algorithms / programming of the calculation unit and evaluation unit, which the Applicant argues would make the claims patent eligible under Step 2B. Examiner respectfully disagrees.
The claimed additional elements are: sheet sensor, bed, acquisition unit, calculation unit, and evaluation unit in independent Claim 1; sheet sensor and bed in independent Claim 7, and a non-transitory computer-readable medium, computer, sheet sensor, and bed in independent Claim 9. Given their broadest, reasonable interpretations, the additional elements are either generic computer components for performing generic computer functions or categorized as extra-solution activity, in the form of data-gathering. Regardless of the programming / algorithms used, all generic computers have a processor, with an input and output. There is nothing special about these elements, as there are no limitations regarding specialized hardware for these structures.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered. The rejections are withdrawn in view of the amendment.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“acquisition unit” in Claim 1: [0020] of the Applicant’s Specification recites “Each unit of the acquisition unit 42, the calculation unit 43, and the evaluation unit 44 may be realized in a hardware manner using a logic circuit or the like, or may be realized in a software manner using a CPU or the like”
“calculation unit” in Claim 1: [0020] of the Applicant’s Specification recites “Each unit of the acquisition unit 42, the calculation unit 43, and the evaluation unit 44 may be realized in a hardware manner using a logic circuit or the like, or may be realized in a software manner using a CPU or the like”
“evaluation unit” in Claim 1: [0020] of the Applicant’s Specification recites “Each unit of the acquisition unit 42, the calculation unit 43, and the evaluation unit 44 may be realized in a hardware manner using a logic circuit or the like, or may be realized in a software manner using a CPU or the like”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objection
Claim 9 is objected to because of the following informality:
Claim 9 recites “acquiring the respiratory waveform of a target patient” in line 6, but should read “acquiring the respiratory waveform of the target patient”
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, 7, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1, 4, 7, and 9 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1, 4, 7, and 9 recite an evaluation system for evaluating a severity of pneumonia, a series of steps or acts for evaluating a severity of pneumonia, and a non-transitory computer-readable recording medium that, when executed by a computer, performs a method for evaluating a severity of pneumonia. Thus, the claims are directed to either a machine and a process, which both fall under the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1, 4, 7, and 9 recites at least one step or instruction for evaluating a severity of pneumonia, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1, 4, 7, and 9 recites an abstract idea.
Specifically, Claim 1 recites:
a sheet sensor for generating a signal comprising a respiratory waveform of the target patient having pneumonia, wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure;
an acquisition unit for acquiring the respiratory waveform of the target patient from the sheet sensor;
a calculation unit for calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform, wherein the calculation unit calculates a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and
an evaluation unit for evaluating the severity of pneumonia based on the calculated value of the index, wherein the evaluation unit evaluates the severity as high when the calculated RST is below a threshold value, the threshold value being 26 seconds.
Specifically, Claim 7 recites:
generating a signal with a sheet sensor, wherein the signal comprises a respiratory waveform of the target patient having pneumonia, wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure;
acquiring the respiratory waveform of the target patient from the sheet sensor;
calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform, including calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and
evaluating the severity of pneumonia based on the calculated value of the index, including evaluating the severity as high when the calculated RST is below a threshold value, the threshold value being 26 seconds.
Specifically, Claim 9 recites:
generating a signal with a sheet sensor, wherein the signal comprises a respiratory waveform of a target patient having pneumonia, wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure;
acquiring the respiratory waveform of a target patient from the sheet sensor;
calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform, including calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and
evaluating a severity of pneumonia based on the calculated value of the index, including evaluating the severity as high when the calculated RST is below a threshold value, the threshold value being 26 seconds.
Further, dependent claim 4 merely includes limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea (underlines above) in each of independent Claims 1, 7, and 9 (and dependent claim 4) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in bold in independent Claims 1, 7, and 9), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: sheet sensor, bed, acquisition unit, calculation unit, and evaluation unit in independent Claim 1; sheet sensor and bed in independent Claim 7, and a non-transitory computer-readable medium, computer, sheet sensor, and bed in independent Claim 9 are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 7, and 9 (and dependent claim 4) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., acquisition unit, calculation unit, and evaluation unit as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 7, and 9 (and dependent claim 4) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 7, and 9 (and dependent claim 4) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1, 4, 7, and 9 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: sheet sensor, bed, acquisition unit, calculation unit, and evaluation unit in independent Claim 1; sheet sensor and bed in independent Claim 7, and a non-transitory computer-readable medium, computer, sheet sensor, and bed in independent Claim 9.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by the Applicant’s specification (e.g. paragraphs [0013]-[0024]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. acquiring, calculating, and evaluating) that are well-understood, routine, and conventional activities previously known to the pertinent industry; Applicant’s Background in the specification; and the non-patent literature of record in the application.
Furthermore, Doherty et al (U.S. Patent No. 8,617,068) discloses a method and apparatus for assessing sleep quality that recognizes the combination of a sheet sensor and bed to be well-understood, routine, and conventional. Doherty cites multiple ways to obtain objective measurements of the patient’s sleep quality, and cites Van der Loos et al (U.S. Patent No. 6,468,234), which describes a method and apparatus for measuring sleep quality that utilizes sensors incorporated in a sheet which is laid on top of a conventional mattress on which the subject sleeps, interface software for collecting user lifestyle data, and lifestyle correlation software for correlating the lifestyle data with the data acquired by said array of sensors.
Accordingly, in light of Applicant’s specification, the claimed terms acquisition unit, calculation unit, and evaluation unit are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the acquisition unit, calculation unit, and evaluation unit. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1, 4, 7, and 9 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system, method, and medium of Claims 1, 4, 7, and 9 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1, 4, 7, and 9 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 7, and 9 (and dependent claim 4) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 4, 7, and 9 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 4, 7, and 9 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 4, 7, and 9 are not patent eligible and rejected under 35 U.S.C. 101.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Maslik et al (U.S. Publication No. 2021/0398666; previously cited) in view of Teijin Pharma Ltd (JP 2014210034; cited by Applicant; machine translation is referred to below).
Regarding Claim 1, Maslik discloses an evaluation system for evaluating a severity of pneumonia in a target patient (Systems, apparatus and methods for acquisition, storage, and analysis of health and environmental data; Abstract), the system comprising:
a sheet sensor (‘semi-contact’ sensor 455) for generating a signal comprising a respiratory waveform of the target patient having pneumonia (Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]; FIG. 10 shows an example graph 1000 of respiration rate over time and an example graph 1010 of temperature over time, in accordance with at least one embodiment of the present disclosure. A patient with mild COVID-19 pneumonia showed an upward trend 1020 in respiratory rate (RR) for several hours before fever 1040 was first noted by routine spot measurements. A measurement of high respiratory rate 1030 approximately coincided with the onset of fever 1040. This demonstrates the sensitivity of the disclosed system to changes to physiological state that accompany COVID-19 infections; [0273]), wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure (a ‘semi-contact’ sensor 455 such as an accelerometer or pressure sensor may be used when the apparatus 120 is connected to the bed or mattress of the patient. In this case, presence, motion (and derived respiration and heart activity) can be obtained; [0071]);
an acquisition unit for acquiring the respiratory waveform of the target patient from the sheet sensor (The apparatus or device 120 captures raw data 130 (e.g., ambient sensor data, audio data, button press data, etc.) from the plurality of sensors, and may perform waveform analysis to yield processed data 140, which may for example include respiration…the system 100 employs four different raw data types whose importance may be ranked as follows: 1. health (physiological, such as respiration rate; [0043]);
a calculation unit for calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform (Respiratory rate (RR) is monitored continuously and compared to user-defined Lower and Upper RR threshold values, which together describe a ‘healthy’ RR range…the metrics Average, Minimum, and Maximum RR, as well as distribution metrics Median, 1st quartile, 3rd quartile RR, may for example computed for all RR values obtained in the past 60 minutes, as well as in the past 24 hours of a patient…Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days; [0222-0228]); and
an evaluation unit for evaluating the severity of pneumonia based on the calculated value of the index, wherein the evaluation unit evaluates the severity based on a threshold value (The raw data 130 and/or the processed data 140 may then be transferred to a remote processing and storage unit 150 (e.g., over a network 155 such as a local area network (LAN), wide area network (WAN), wireless network, cellular network, etc.). The remote processing and storage unit 150 may then analyze the raw data 130 and/or processed data 140 to yield a sleep analysis 160 (e.g., a hypnogram, bed and rise times, sleep quality metrics), a combined health, sleep, and behavior analysis 170 (e.g., statistics, summaries, trends, alerts, insights, and diagnostics), and/or other analyses of health, behavior, environment, sleep, physiology, or combinations thereof…software on the computer 180 or mobile device 190 may also provide alerts and notifications providing user advice, such as recommended actions to improve health or sleep. Software on the computer 180 or mobile device 190 may also provide data visualization and analysis, device configuration, user-defined thresholds, and reporting; [0044]; Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]).
Maslik fails to disclose wherein the calculation unit calculates a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and wherein the evaluation unit evaluates the severity as high when the calculated RST is below a threshold value.
In a similar technical field, Teijin Pharma Ltd teaches an evaluation system for evaluating a severity of a condition in a target patient (Diagnostic method and diagnostic system; Abstract), wherein the calculation unit calculates a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index (the respiratory stability index (RSI), as a tool for assessing the severity of patients with heart failure and use it to assess the prognosis in this fatal disease…the RSI index is a quantitative evaluation indicating the instability of breathing motion, and the fact that the RSI index is less than 20 (1 / Hz), for example, less than 20 (1 / Hz) is a serious pathological condition. It becomes an index for predicting that It has been found that the stability of breathing motion taught by the RSI index can detect heart failure patients (particularly chronic heart failure) having unstable breathing patterns and can be utilized as a new treatment option; Page 4 Paragraphs 3-4; RSI extracts a respiratory cycle band from a respiratory waveform, calculates a standard deviation of a frequency of 5% or more of the maximum value of the respiratory frequency component, and calculates it as the reciprocal of the standard deviation. RSI = 1 / A (A = standard deviation of the frequency of 5% or more of the maximum value of the respiratory frequency component); Page 5 Paragraphs 4-5); and wherein the evaluation unit evaluates the severity as high when the calculated RST is below a threshold value (When the RSI value is 20 (1 / Hz) or less, the state of heart failure has deteriorated (sympathetic nerve activity has increased, pulmonary congestion has worsened, symptoms have become stronger, etc.) It was found that when it was 90 (1 / Hz) or more, it was in a stable state close to a deep sleep state. Therefore, in the present invention, it is possible to provide a diagnostic apparatus or diagnostic method that uses the numerical value to predict the prognosis of heart failure or quantitatively evaluate the severity of heart failure; Page 5 Paragraph 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the RSI teachings of Teijin Pharma Ltd into the invention of Maslik in order to provide a measure of respiratory stability that can quantitatively display the variation in the respiratory cycle to provide the most accurate diagnosis (Teijin Pharma Ltd Page 5 Paragraphs 4-7).
Although Teijin Pharma Ltd discloses wherein the threshold value is 20 or less (Page 5 Paragraph 7), Teijin Pharma Ltd does not explicitly disclose the threshold value being 26 seconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the threshold of Teijin Pharma Ltd from 20 to 26, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range (see [0023] of the Applicant’s Specification, which indicates that “the threshold value is preferably 20 to 30 seconds”).
Regarding Claim 4, Maslik discloses wherein the target patient is positive for COVID-19 (FIG. 10 shows an example graph 1000 of respiration rate over time and an example graph 1010 of temperature over time, in accordance with at least one embodiment of the present disclosure. A patient with mild COVID-19 pneumonia showed an upward trend 1020 in respiratory rate (RR) for several hours before fever 1040 was first noted by routine spot measurements. A measurement of high respiratory rate 1030 approximately coincided with the onset of fever 1040. This demonstrates the sensitivity of the disclosed system to changes to physiological state that accompany COVID-19 infections; [0273]).
Regarding Claim 7, Maslik discloses evaluation method for evaluating a severity of pneumonia in a target patient (Systems, apparatus and methods for acquisition, storage, and analysis of health and environmental data; Abstract), the method comprising:
generating a signal with a sheet sensor (‘semi-contact’ sensor 455), wherein the signal comprises a respiratory waveform of the target patient having pneumonia (Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]; FIG. 10 shows an example graph 1000 of respiration rate over time and an example graph 1010 of temperature over time, in accordance with at least one embodiment of the present disclosure. A patient with mild COVID-19 pneumonia showed an upward trend 1020 in respiratory rate (RR) for several hours before fever 1040 was first noted by routine spot measurements. A measurement of high respiratory rate 1030 approximately coincided with the onset of fever 1040. This demonstrates the sensitivity of the disclosed system to changes to physiological state that accompany COVID-19 infections; [0273]), wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure (a ‘semi-contact’ sensor 455 such as an accelerometer or pressure sensor may be used when the apparatus 120 is connected to the bed or mattress of the patient. In this case, presence, motion (and derived respiration and heart activity) can be obtained; [0071]);
acquiring the respiratory waveform of the target patient from the sheet sensor (The apparatus or device 120 captures raw data 130 (e.g., ambient sensor data, audio data, button press data, etc.) from the plurality of sensors, and may perform waveform analysis to yield processed data 140, which may for example include respiration…the system 100 employs four different raw data types whose importance may be ranked as follows: 1. health (physiological, such as respiration rate; [0043]);
calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform (Respiratory rate (RR) is monitored continuously and compared to user-defined Lower and Upper RR threshold values, which together describe a ‘healthy’ RR range…the metrics Average, Minimum, and Maximum RR, as well as distribution metrics Median, 1st quartile, 3rd quartile RR, may for example computed for all RR values obtained in the past 60 minutes, as well as in the past 24 hours of a patient…Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days; [0222-0228]); and
evaluating the severity of pneumonia based on the calculated value of the index, including evaluating the severity based on a threshold value (The raw data 130 and/or the processed data 140 may then be transferred to a remote processing and storage unit 150 (e.g., over a network 155 such as a local area network (LAN), wide area network (WAN), wireless network, cellular network, etc.). The remote processing and storage unit 150 may then analyze the raw data 130 and/or processed data 140 to yield a sleep analysis 160 (e.g., a hypnogram, bed and rise times, sleep quality metrics), a combined health, sleep, and behavior analysis 170 (e.g., statistics, summaries, trends, alerts, insights, and diagnostics), and/or other analyses of health, behavior, environment, sleep, physiology, or combinations thereof…software on the computer 180 or mobile device 190 may also provide alerts and notifications providing user advice, such as recommended actions to improve health or sleep. Software on the computer 180 or mobile device 190 may also provide data visualization and analysis, device configuration, user-defined thresholds, and reporting; [0044]; Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]).
Maslik fails to disclose calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and evaluating the severity as high when the calculated RST is below a threshold value.
In a similar technical field, Teijin Pharma Ltd teaches an evaluation system for evaluating a severity of a condition in a target patient (Diagnostic method and diagnostic system; Abstract), comprising calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index (the respiratory stability index (RSI), as a tool for assessing the severity of patients with heart failure and use it to assess the prognosis in this fatal disease…the RSI index is a quantitative evaluation indicating the instability of breathing motion, and the fact that the RSI index is less than 20 (1 / Hz), for example, less than 20 (1 / Hz) is a serious pathological condition. It becomes an index for predicting that It has been found that the stability of breathing motion taught by the RSI index can detect heart failure patients (particularly chronic heart failure) having unstable breathing patterns and can be utilized as a new treatment option; Page 4 Paragraphs 3-4; RSI extracts a respiratory cycle band from a respiratory waveform, calculates a standard deviation of a frequency of 5% or more of the maximum value of the respiratory frequency component, and calculates it as the reciprocal of the standard deviation. RSI = 1 / A (A = standard deviation of the frequency of 5% or more of the maximum value of the respiratory frequency component); Page 5 Paragraphs 4-5); and evaluating the severity as high when the calculated RST is below a threshold value (When the RSI value is 20 (1 / Hz) or less, the state of heart failure has deteriorated (sympathetic nerve activity has increased, pulmonary congestion has worsened, symptoms have become stronger, etc.) It was found that when it was 90 (1 / Hz) or more, it was in a stable state close to a deep sleep state. Therefore, in the present invention, it is possible to provide a diagnostic apparatus or diagnostic method that uses the numerical value to predict the prognosis of heart failure or quantitatively evaluate the severity of heart failure; Page 5 Paragraph 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the RSI teachings of Teijin Pharma Ltd into the invention of Maslik in order to provide a measure of respiratory stability that can quantitatively display the variation in the respiratory cycle to provide the most accurate diagnosis (Teijin Pharma Ltd Page 5 Paragraphs 4-7).
Although Teijin Pharma Ltd discloses wherein the threshold value is 20 or less (Page 5 Paragraph 7), Teijin Pharma Ltd does not explicitly disclose the threshold value being 26 seconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the threshold of Teijin Pharma Ltd from 20 to 26, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range (see [0023] of the Applicant’s Specification, which indicates that “the threshold value is preferably 20 to 30 seconds”).
Regarding Claim 9, Maslik discloses a non-transitory computer-readable recording medium that, when executed by a computer (results can be provided by computer system 800 in response to processor 804 executing one or more sequences of one or more instructions contained in memory 806. Such instructions can be read into memory 806 from another computer-readable medium or computer-readable storage medium, such as storage device 810. Execution of the sequences of instructions contained in memory 806 can cause processor 804 to perform the processes described herein; [0261]), performs a method comprising:
generating a signal with a sheet sensor (‘semi-contact’ sensor 455), wherein the signal comprises a respiratory waveform of a target patient having pneumonia (Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]; FIG. 10 shows an example graph 1000 of respiration rate over time and an example graph 1010 of temperature over time, in accordance with at least one embodiment of the present disclosure. A patient with mild COVID-19 pneumonia showed an upward trend 1020 in respiratory rate (RR) for several hours before fever 1040 was first noted by routine spot measurements. A measurement of high respiratory rate 1030 approximately coincided with the onset of fever 1040. This demonstrates the sensitivity of the disclosed system to changes to physiological state that accompany COVID-19 infections; [0273]), wherein the sheet sensor is positioned below the target patient on a bed, and the sheet sensor detects body pressure (a ‘semi-contact’ sensor 455 such as an accelerometer or pressure sensor may be used when the apparatus 120 is connected to the bed or mattress of the patient. In this case, presence, motion (and derived respiration and heart activity) can be obtained; [0071]);
acquiring the respiratory waveform of a target patient from the sheet sensor (The apparatus or device 120 captures raw data 130 (e.g., ambient sensor data, audio data, button press data, etc.) from the plurality of sensors, and may perform waveform analysis to yield processed data 140, which may for example include respiration…the system 100 employs four different raw data types whose importance may be ranked as follows: 1. health (physiological, such as respiration rate; [0043]);
calculating a value of an index indicating instability of a respiratory frequency from the respiratory waveform (Respiratory rate (RR) is monitored continuously and compared to user-defined Lower and Upper RR threshold values, which together describe a ‘healthy’ RR range…the metrics Average, Minimum, and Maximum RR, as well as distribution metrics Median, 1st quartile, 3rd quartile RR, may for example computed for all RR values obtained in the past 60 minutes, as well as in the past 24 hours of a patient…Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days; [0222-0228]); and
evaluating a severity of pneumonia based on the calculated value of the index, including evaluating the severity based on a threshold value (The raw data 130 and/or the processed data 140 may then be transferred to a remote processing and storage unit 150 (e.g., over a network 155 such as a local area network (LAN), wide area network (WAN), wireless network, cellular network, etc.). The remote processing and storage unit 150 may then analyze the raw data 130 and/or processed data 140 to yield a sleep analysis 160 (e.g., a hypnogram, bed and rise times, sleep quality metrics), a combined health, sleep, and behavior analysis 170 (e.g., statistics, summaries, trends, alerts, insights, and diagnostics), and/or other analyses of health, behavior, environment, sleep, physiology, or combinations thereof…software on the computer 180 or mobile device 190 may also provide alerts and notifications providing user advice, such as recommended actions to improve health or sleep. Software on the computer 180 or mobile device 190 may also provide data visualization and analysis, device configuration, user-defined thresholds, and reporting; [0044]; Respiratory Trend data: A notification is issued if median hourly or daily RR shows a trend (increasing or decreasing) over the course of multiple hours or days. By default, an analysis window length of 2-10 days is set, with a trend being detected through regression analysis. Respiratory waveform feature data are used to identify various respiratory patterns associated with illness, such as…shortness of breath, detected from reduction in breath amplitude and increased RR, is associated with conditions such as pneumonia, sepsis, acute respiratory distress, and COVID-19…for all respiratory patterns indicating potential adverse events or risk of deterioration, notifications and alerts may be issued to healthcare professionals; [0228-0234]).
Maslik fails to disclose calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index; and evaluating the severity as high when the calculated RST is below a threshold value.
In a similar technical field, Teijin Pharma Ltd teaches an evaluation system for evaluating a severity of a condition in a target patient (Diagnostic method and diagnostic system; Abstract), comprising calculating a respiratory stability time (RST), which is a reciprocal of a standard deviation of the respiratory frequency, as the value of the index (the respiratory stability index (RSI), as a tool for assessing the severity of patients with heart failure and use it to assess the prognosis in this fatal disease…the RSI index is a quantitative evaluation indicating the instability of breathing motion, and the fact that the RSI index is less than 20 (1 / Hz), for example, less than 20 (1 / Hz) is a serious pathological condition. It becomes an index for predicting that It has been found that the stability of breathing motion taught by the RSI index can detect heart failure patients (particularly chronic heart failure) having unstable breathing patterns and can be utilized as a new treatment option; Page 4 Paragraphs 3-4; RSI extracts a respiratory cycle band from a respiratory waveform, calculates a standard deviation of a frequency of 5% or more of the maximum value of the respiratory frequency component, and calculates it as the reciprocal of the standard deviation. RSI = 1 / A (A = standard deviation of the frequency of 5% or more of the maximum value of the respiratory frequency component); Page 5 Paragraphs 4-5); and evaluating the severity as high when the calculated RST is below a threshold value (When the RSI value is 20 (1 / Hz) or less, the state of heart failure has deteriorated (sympathetic nerve activity has increased, pulmonary congestion has worsened, symptoms have become stronger, etc.) It was found that when it was 90 (1 / Hz) or more, it was in a stable state close to a deep sleep state. Therefore, in the present invention, it is possible to provide a diagnostic apparatus or diagnostic method that uses the numerical value to predict the prognosis of heart failure or quantitatively evaluate the severity of heart failure; Page 5 Paragraph 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the RSI teachings of Teijin Pharma Ltd into the invention of Maslik in order to provide a measure of respiratory stability that can quantitatively display the variation in the respiratory cycle to provide the most accurate diagnosis (Teijin Pharma Ltd Page 5 Paragraphs 4-7).
Although Teijin Pharma Ltd discloses wherein the threshold value is 20 or less (Page 5 Paragraph 7), Teijin Pharma Ltd does not explicitly disclose the threshold value being 26 seconds. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the threshold of Teijin Pharma Ltd from 20 to 26, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range (see [0023] of the Applicant’s Specification, which indicates that “the threshold value is preferably 20 to 30 seconds”).
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 CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J JHIN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791