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 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.
1. 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 limitation(s) is/are:
The “electrocardiogram measurement unit” of claim 1 is being interpreted as a wearable electrocardiogram patch, a smartwatch, or a 6-lead electrocardiogram bar (Page 8 of the Specification).
The “electrocardiogram generation unit” of claim 1 is being interpreted as anything that can generate multi-lead electrocardiogram data since no structure has been given.
The “output unit” of claim 1 is being interpreted as anything that can output and provide the actual electrocardiogram data measured by the electrocardiogram measurement unit and the plurality of pieces of lead electrocardiogram data generated by the electrocardiogram generation unit to medical staff since no structure has been given.
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.
2. Claims 1-8 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.
In regards to claim 1, the claim limitations “an electrocardiogram generation unit” and “an output unit” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-8 are rejected by virtue of their dependency.
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.
3. Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claim 1 recites a method for “generating a plurality of pieces of standard electrocardiogram data using 2-lead electrocardiogram data” by using “an electrocardiogram measurement unit configured to generate electrocardiogram data…generate[ing] multi-lead electrocardiogram data by identifying and computing characteristic information of the 2- or more-lead standard lead electrocardiogram data … and output[ing] the actual electrocardiogram data”. The limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, taking in ECG data and then characterizing it could simply be done by looking at the data on a printout or screen or could be accomplished mentally. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application.
The components are recited at a high-level of generality such that it amounts no more than any structure that can look a gather ECG data and perform analyses on it. Further, the use of vector analysis in the dependent claims, are merely insignificant extra-solution activity of data gathering/analyzing. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The additional elements, such as the measurement unit to gather ECG data and the algorithms used for vector analysis, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of measurement units to gather patient information are well known in the art as disclosed by the following references: US 20210259560 A1 and US 20210244339 A1. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Venkatraman (US 20210259560 A1).
In regards to claim 1, Venkatraman discloses the system for generating a plurality of pieces of standard electrocardiogram data using 2-lead electrocardiogram data (Abstract and Par. 0072 teach gathering ECG data from a single to 12 lead ECG system), the system comprising:
an electrocardiogram measurement unit configured to generate electrocardiogram data by measuring 2- or more-lead standard lead electrocardiograms (Par. 0040-0041 teach a monitoring device to gather the ECG data in the form of a patch);
an electrocardiogram generation unit configured to generate multi-lead electrocardiogram data by identifying and computing characteristic information of the 2- or more-lead standard lead electrocardiogram data and synthesizing a plurality of pieces of residual lead electrocardiogram data in a three-dimensional space through a pre-trained rule- based algorithm (Par. 0110-0111 teaches an algorithm that can take in data from the ECG and then characterize/classify the data); and
an output unit configured to output the actual electrocardiogram data measured by the electrocardiogram measurement unit and the multi-lead electrocardiogram data generated by the electrocardiogram generation unit (Par. 0112 teaches then outputting this data in the form of labels, numerical vales, etc. Par. 0165 teaches a display on a user interface to sow any output data).
In regards to claim 2, Venkatraman discloses the system of claim 1, wherein the rule-based algorithm determines two coordinate axes corresponding to potential vectors by analyzing 2-lead electrocardiogram data accumulated in medical institutions and direction information of the individual potential vectors of the 2-lead electrocardiogram data, generates an additional potential vector by computing the two potential vectors to generate the 3D space, and generates the multi-lead electrocardiogram data corresponding to potential vector directions of respective pieces of standard lead electrocardiogram data by projecting the electrocardiogram data in a potential vector direction of the residual lead electrocardiogram data in the 3D space (Par. 0057-0058 teach an algorithm is employed to take in different axes of the ECG and determining an ECG vector direction from this. Fig 10 also shows this being determined in a 3D space)
In regards to claims 3-4, Venkatraman discloses the system of claim 2, wherein the rule-based algorithm generates the additional electric potential vector by subtracting the two electric potential vectors from each other, and generates the 3D space composed of the three electric potential vectors and wherein the rule-based algorithm generates the 3D space by separating 3D components from the two potential vectors (Fig 10 and Par. 0058 teach this being done in 3D space as well as using ECG vectors in the x, y, and z directions).
In regards to claims 5 and 8, Venkatraman discloses the system of claim 3/4, wherein the rule-based algorithm generates four-dimensional electrocardiogram data by adding a time axis to the 3D space using time-series information included in the electrocardiogram data (Par. 0062-0065 teach adding in time information with the ECG data).
In regards to claim 6, Venkatraman discloses the system of claim 2, wherein the rule-based algorithm visualizes coordinate axes of the 3D space constructed by the potential vectors and the additional potential vector or outputs numerical information of the additional potential vector through a mathematical expression algorithm configured to extract the additional potential vector from the potential vectors, calculates a coordinate axis corresponding to a potential vector of the residual lead electrocardiogram data, and generates electrocardiogram data corresponding to the coordinate axis (Par. 0057 and Fig 10 teach creating a coordinate system corresponding to the ECG vector data using the algorithm).
In regards to claim 7, Venkatraman discloses the system of claim 1, wherein the multi-lead electrocardiogram data is synchronous lead electrocardiogram data, asynchronous lead electrocardiogram data, or lead electrocardiogram data generated without consideration of synchronization (Par. 0188 teaches using synchronized ECG data).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format.
For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792