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 Objections
Claims 11 and 20 are objected to because of the following informalities:
Claim 11: “thethe” should read as “the.”
Claim 20: “chronotrop” should read as “chronotropic” or “chronotrope.”
Appropriate correction is required.
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 use the word “means,” and are therefore 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 the term “means” coupled with functional language without reciting sufficient structure to perform the recited function and the term “means” is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 9:
“means for receiving an electrocardiogram (ECG) signal and a photoplethysmography signal from the patient,”
“means for determining the R-peak of the ECG signal”
“means for determining the foot of the pulse wave signal”
“means for calculating an estimated Pulse Wave Velocity (PWV)”
“(f) means for storing the estimated PWV in a database”
In Claim 10:
“means for storing the estimated MAPest”
In Claim 11:
“means for calculating the height of the dicrotic wave”
In Claim 12:
“means for displaying or exporting the estimated PWV”
In Claim 13:
“means for calculating an average PWV”
In Claim 14:
“means for displaying or exporting the average PWV, and/or the lowest estimated PWV and/or the highest estimated PWV.”
As best understood, since Applicant’s Specification at Page 14 describes the invention as pertaining to a computer product/program for carrying out the steps of the method, including each function of the means delineated above, each means recited in the device claim of independent claim 9 is interpretable as a function carried out by a generic computer processor. Each remaining means recited in the dependent claims are treated analogously.
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 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 1, 9, 10, and dependent claims thereof 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.
Re. Claims 1 and 9: Examiner notes that the function utilized to evaluate pulse wave velocity is not expressed clearly as an equation. It is unclear how pulse wave velocity is extracted from “an end result” of a function. It is unclear whether “an end result” intends to signify evaluation of the claimed function or if further calculation steps are required to identify pulse wave evaluation from, e.g., rearrangement of the function or derivation from the claimed function. Each other instance of “PWV” in dependent claims is thus unclear since the process of obtaining PWV as it relates to the claimed function is unclear.
Additionally, if the function is intended to equal pulse wave velocity in seconds, multiplying units of meters per second (m/s) with age in years does not yield that a pulse wave velocity in seconds without further unit conversion.
Claim 9 additionally recites the following terms which do not possess adequate antecedent basis:
“the R-peak”
“the foot”
“the pulse wave signal”
“the Pulse Arrival Time (PAT)”
“the PPG signal;” Examiner notes that such an acronym is not defined after the first instance of reciting “a plethysmography signal.”
Re. Claim 10: The variable MAPest is not clearly defined as the acronym for estimated mean arterial pressure in claim 10 or prior claims. This makes it unclear whether “it” refers to an estimated Mean Arterial Pressure or the undefined variable MAPest.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
Independent claim 1 recites a method for evaluating pulse wave velocity by combining factors such as age, carotid-femoral distance, and pulse arrival time in a function, which in and of itself is merely an abstract process of evaluation capable of being carried out mentally or by pen-and-paper practice.
Independent claim 9 recites various “means for receiving” an electrocardiography (ECG) signal and a photoplethysmography (PPG) signal, which are directed to data-gathering elements. Claim 9 further recites “means for determining” features of the acquired signals, and further means for calculating including the calculation of claim 1; such means are interpreted as no more than carrying out the abstract idea of judgement, observation, and/or evaluation on gathered data. Claim 9 further recites means for storing an estimated PWV in a database, which amounts to no more than extra-solution activity of data output to a generic computer component for storing data.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of a mathematical formula) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea or limitations relating to the data gathered/post-solution activity and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use since they are incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, 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:
Independent claim 1 does not recite any additional elements. As best understood, it is purely abstract evaluation.
Independent claim 9 recites various “means” interpreted under 35 U.S.C. 112(f). A generic computer is capable of communicating with or possessing “means for receiving” signals generated from known sensors such as ECG and PPG sensors. A generic computer is further capable of carrying out each “determining” and “calculating” step claimed. Thus, independent claim 9 requires, at most, known sensors (e.g., ECG and PPG) and a generic computer processor for analyzing data therefrom.
Such additional elements are generic and do not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from implied sensors, having no operative connection to the implied processing components besides communication of obtained data, which amounts to insignificant, extra-solution activity in the form of mere data gathering, which does not constitute an integration into a practical application. Even if the sensors implied particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
Furthermore, the implicit processing components are recited at a high-level of generality (i.e., a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not 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 (i.e., pulse wave calculation), such that the claim as a whole is more than a drafting effort designed to monopolize the exception (i.e., as best understood, a mathematical formula). Furthermore, the above-identified generically recited 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 is not integrated into a practical application.
Dependent claims 2-8, 10-14, and 18 merely define further steps related to the mental process, conditions for the data gathered, and insignificant post-solution activity such as storage or exporting data (i.e., interpretable as generically-recited data output).
Dependent claims 15 and 16 recite generic computer components for carrying out the abstract idea at a high level of generality.
Dependent claims 17, 19, and 20 recite administering known drugs for treating hypertension and/or hypotension, which is not considered a particular treatment or prophylaxis, and amounts to no more than administering known drugs at undisclosed amounts based on identification of symptoms such drugs are typically intended to treat.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
As stated previously in the analysis under Step 2A, Prong Two, independent claim 1 does not recite any additional elements.
As stated previously in the analysis under Step 2A, Prong Two, independent claim 9 recites, essentially, known sensors (i.e., ECG and PPG) and a generic computer processor.
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed ECG or PPG sensors, and recites that such sensors for detecting biometric information may be considered “generalized” (Paragraph 0318). No special programming or algorithms is indicated for how such sensors operate. 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 medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is 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).
Analysis of Applicant’s identified implicit generic computer components are also considered generic/conventional. This is further understood by Applicant’s dependent claims requiring the method to be “computer-implemented” or embodied by a “computer program product” understood to be executed via a generic device (see dependent claims 15 and 16).
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 and merely utilize already available computers and sensors with their already available basic functions to use as tools in executing the claimed process.
See discussion of each dependent claim in the analysis under Step 2A, Prong Two; each dependent claim, even when viewed in combination with the judicial exception recited in the independent claims, does not recite significantly more than the judicial exception since they are directed to: 1) further steps of the mental process, 2) conditions for the data gathered, 3) insignificant post-solution activity, generic computer components for carrying out the abstract idea at a high level of generality, and 4) non-particular treatment or prophylaxis.
Examiner notes that dependent claims which recite limitations that are extra-solution or part of the abstract idea itself do not constitute significantly more and furthermore cannot constitute an improvement. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Additional claims which amount to 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 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.
For at least the above reasons, the claims are directed to applying an abstract idea 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. In other words, none of the claims provide 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 the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (evaluating PWV). 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. As such, the above-identified additional elements, when viewed as whole, 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, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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