DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is a system (Step 1) directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1-3 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of claims 1-3 recites at least one step or instruction for , which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a mathematical concept in MPEP 2106.04(a)(2)(I).
Accordingly, each of claims 1-3 recites an abstract idea.
Specifically, Claim 1 recites
A blood pressure measuring device (BPMD) adapted to non-invasively measure blood pressure (BP) of a person via a finger comprising:
a) a housing; (additional element)
b) an inflatable bladder for measuring BP integral with the housing and adapted to apply pressure to a finger pad portion of the finger when inflated (additional element)
c) a pump and a relief valve for inflating and deflating the bladder, respectively, a pressure sensor for providing data indicative of air pressure and air pressure oscillations in the bladder, each of the pump, relief valve and pressure sensor disposed in the housing (additional element)
d) there being no light emitter or detector systems employed to provide an indication of BP; (additional element)
e) a control system, comprising a microprocessor and a memory, disposed in the housing and coupled to the bladder, the pump, the relief valve and the pressure sensor, the memory having program instructions for execution by the microprocessor stored therein for controlling the operation of the pump and the relief valve and for processing data received from the pressure sensor by: (additional element)
i) monitoring pressure data from the pressure sensor including a pressure waveform detected in the pressure data; (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
ii) inflating the bladder to a predetermined pressure sufficient to substantially occlude blood flow in portions of arteries of the finger inside the bladder; (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
iii) stopping bladder inflation when the predetermined pressure has been reached (inflation pressure) and thereafter controllably deflating the bladder; (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
iv) detecting resumption of blood flow in the arteries by monitoring the oscillometric pressure waveform; (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
v) detecting when normal flow has resumed by monitoring the oscillometric pressure waveform; (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
vi) calculating an indication of BP based on the oscillometric pressure waveform by generating a heart rate power spectrum from the waveform, convolving the power spectrum, and applying a fixed ratio method to provide an indication of systolic and diastolic BP; (mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP 2106.04(a)(2)(I))) and/or a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
vii) wherein none of steps g(i)-g(v) employ data from a light emitter or a light detector (a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
f) the housing, bladder, pump, relief valve and control system being a single integral, self-contained, stand-alone unit. (additional element)
Further, dependent claims 2-3 merely include 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 claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 (and their respective dependent Claims 2-3) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: pressure sensor, control system, comprising a microprocessor and a memory are generically recited computer elements in independent Claims 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) 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., processor 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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 Claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1-3 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: pressure sensor, control system, comprising a microprocessor and a memory
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, MPEP 2106.05(d)(II) along with 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.
Per Applicant’s specification, [0051] details obtaining a digital pressure reading from an analog pressure sensor which is widely known and is a generically and commercially available product. Additionally, per applicant’s specification [0037] and [0060] the microprocessor can utilize a program code (i.e. in the memory) to process the data or send the data to a separate system such as a smart phone for processing which is described with such generality as a commercially available product.
Accordingly, in light of Applicant’s specification, the claimed terms control system and microprocessor is 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 technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the digital processors or microcontrollers. 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1-3 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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 of Claims 1-3 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 providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 18 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-3 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-3 are not patent eligible and rejected 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.
Claim 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the limitation “vii) wherein none of steps g(i)-g(vi) employ data from a light emitter or a light detector.” However, there isn’t a step g(i)-g(vi) and makes the claim unclear. The examiner has understood this to be in error and should read “vii) wherein none of steps e(i)-e(vi) employ data from a light emitter or a light detector.” The claims will be examined based on this interpretation and understanding.
Claim 2 is currently written to be dependent upon claim 2, which makes the claim unclear. The examiner has understood this to be in error and should read “The BPMD according to claim 1,…” and the claims will be examined based on this interpretation and understanding.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Shin (US 2006/0253041 A1) in view of Itonaga (US 5,807,266 A) and Hersh (US 2011/0237962 A1)
Regarding claim 1, Shin discloses A blood pressure measuring device (BPMD) adapted to non-invasively measure blood pressure (BP) of a person via a finger (e.g. abstract) comprising: a) a housing (e.g. [0076] Fig 4a/b:401/402 Fig 10); b) an inflatable bladder for measuring BP integral with the housing and adapted to apply pressure to a finger pad portion of the finger when inflated (e.g. Fig 4b:200a [0028]; [0045]-[0046]); c) a pressure sensor for providing data indicative of air pressure and air pressure oscillations in the bladder (e.g. [0076]; [0080]-[0081] Fig 10:600), there being no light emitter or detector systems employed to provide an indication of BP (e.g. the system does not contain any light emitter or detector systems); e) a control system, disposed in the housing and coupled to the bladder, the pump, the relief valve and the pressure sensor (e.g. Fig 10 [0077] the control unit may be provided in the blood pressure measuring unit), controlling the operation of the blood pressure sensor and for processing data received from the pressure sensor (e.g. [0080]-[0081]) by: i) monitoring pressure data from the pressure sensor including an pressure waveform detected in the pressure data (e.g. [0039]); ii) inflating the bladder to a predetermined pressure sufficient to substantially occlude blood flow in portions of arteries of the finger inside the bladder; iii) stopping bladder inflation when the predetermined pressure has been reached (inflation pressure) and thereafter controllably deflating the bladder; iv) detecting resumption of blood flow in the arteries by monitoring the oscillometric pressure waveform; v) detecting when normal flow has resumed by monitoring the oscillometric pressure waveform (e.g. ([0040]-[0046]; [0049])) vi) calculating an indication of BP based on the oscillometric pressure waveform by applying a fixed ratio method to provide an indication of systolic and diastolic BP (e.g. [0040] Fig 2) vii) wherein none of steps g(i)-g(v) employ data from a light emitter or a light detector (e.g. the system does not contain any light emitter or detector systems) f) the housing, bladder, and control system being a single integral, self-contained, stand-alone unit (e.g. [0076] Fig 4a/b:401/402 Fig 9 [0077] the control unit may be provided in the blood pressure measuring unit).
Shin is silent regarding a pump and a relief valve for inflating and deflating the bladder, each of the pump, relief valve and pressure sensor disposed in the housing respectively and being a single integral, self-contained, stand-alone unit, a control system comprising a microprocessor and a memory, the memory having program instructions for execution by the microprocessor stored therein for controlling the operation of the pump and the relief valve and for processing data received from the pressure sensor vi) calculating an indication of BP based on the oscillometric pressure waveform by generating a heart rate power spectrum from the waveform, convolving the power spectrum, and applying a fixed ratio method to provide an indication of systolic and diastolic BP.
Shin doesn’t explicitly detail a control system comprising a microprocessor and a memory, the memory having program instructions for execution by the microprocessor stored therein for controlling the operation of system and for processing data received from the pressure sensor. However, it details being able to utilize a mobile phone or a portable computer externally to process the data and separately mentions that the data can be processed on-board the blood pressure monitoring device (e.g. [0076] Fig 4a/b:401/402 Fig 9 [0077] the control unit may be provided in the blood pressure measuring unit). Therefore, it would have been obvious to one of ordinary skill to have the control unit comprising a microprocessor and a memory that is integrated into blood pressure monitoring device.
However, Itonaga discloses a finger-type blood pressure monitor with a flexible foldable finger cuff further comprises a pump and a relief valve for inflating and deflating the bladder, each of the pump, relief valve disposed in the housing respectively and being a single integral, self-contained, stand-alone unit (e.g. col 3 lines 63-65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Shin to incorporate the teachings of Itonaga to substitute the current pumping means for a pump and a relief valve for inflating and deflating the bladder, each of the pump, relief valve and pressure sensor disposed in the housing respectively and being a single integral, self-contained, stand-alone unit for the purpose of utilizing another known configuration.
Furthermore, Hersh discloses the use of the frequency spectrum of artifact in oscillometry calculating an indication of BP based on the oscillometric pressure waveform by utilizing a heart rate fundamental frequency from the waveform, and applying a fixed ratio method to provide an indication of systolic and diastolic BP (e.g. Fig 2 [0042]-[0044] claim 1).
While the claims don’t explicitly state by generating a heart rate power spectrum from the waveform, convolving the power spectrum the calculation yields very similar results as it focuses on a dominant/fundamental frequency to center and calculate the energy of the oscillometric signal based on the heart rate in order to calculate the blood pressure and would be obvious variants
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Shin to incorporate the teachings of Hersh to utilize calculating an indication of BP based on the oscillometric pressure waveform by utilizing a heart rate fundamental frequency from the waveform, and applying a fixed ratio method to provide an indication of systolic and diastolic BP and to utilize a convolved power spectrum to obtain it for the purpose of exploiting a known relationship to obtain blood pressure.
Regarding claim 2, modified Shin discloses further comprising a communications system in the housing and adapted to wirelessly transmit the indications calculated by the control system to a system remote from the BPMD (e.g. Shin [0077] Fig 10:998 a wireless communication means).
Regarding claim 3, modified Shin is silent further comprising a display integral with the housing for providing visual indications of BP. Shin does have an external display unit for displaying the measured blood pressure (e.g. [0076] Fig 10:980).
However, Itonaga discloses a finger-type blood pressure monitor with a flexible foldable finger cuff further comprising a display integral with the housing for providing visual indications of BP (e.g. Fig 4:7 col 3 lines 59-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Shin to incorporate the teachings of Itonaga to have a display integral with the housing for providing visual indications of BP for the purpose of having a compact system that is easy to use for the user (e.g. Itonaga Col 4 lines 48-51)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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Jessandra Hough September 29, 2025
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796