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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “126” has been used to designate both the method step of calculating an electrical burden (EB) score using the ECG data (as seen in Fig. 1) and an AF burden score (as seen in Fig. 2). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4-5, and 15-16 are objected to because of the following informalities:
In claim 1, line 10, “a AF complexity metrics” should read “AF complexity metrics”
In claim 4, line 4, “the period” should read “a period”
In claim 5, line 6, “the absolute value” should read “an absolute value”
In claim 5, line 7, “the mean” should read “a mean”
In claim 15, line 4, “the period” should read “a period”
In claim 16, line 6, “the absolute value” should read “an absolute value”
In claim 16, line 7, “the mean” should read “a mean”
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 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 limitations 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. Such claim limitations are: “a controller configured to…” in claims 12, 17, and 19-20.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (See Paragraphs 0045-0046).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 abstract ideas of mental processes and mathematical concepts without significantly more.
Step 1:
Claims 1-11 recite a method and therefore is a process.
Claims 12-20 recite a system and therefore is a product.
Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1 and 12 recite the following limitations:
“receiving electrocardiogram (ECG) data…”
“calculating an AF burden (AFB) score…”
“calculating an electrical burden (EB) score…”
“calculating a complexity AF score…”
“identifying a type of AF complexity and/or a treatment…”
“outputting the complexity AF score, the type of AF complexity, and/or the treatment for the type of AF complexity on a display device”
The limitations, as drafted, describe a process that, under its broadest reasonable
interpretation, includes performance of the limitations in the mind and fall within the mental process grouping of abstract ideas, because they cover concepts performed in the human mind, including observation, evaluation, judgement, and opinion. The limitations, as drafted, also describe a process that, under its broadest reasonable interpretation, includes performing mathematical calculations and determining mathematical relationships. The above limitations disclose “a computer-implemented method” and “a controller” that are receiving the ECG data, calculating an AFB score, calculating an EB score, calculating a complexity AF score, identifying a type of AF complexity and/or treatment, and outputting the results on a display device. Therefore, the “the computer-implemented method” and “the controller” that are performing the receiving step, calculations steps, identification step, and output step are nothing more than a generic computer function of processing data. Nothing in the claims precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitations of “the computer-implemented method” and “the controller” language, the claims encompass receiving data, making calculations and identifications based on that data (mental process), and then generating an output of that identification on a display device (organizing human activity).
Step 2A, Prong 2:
The claims recite “a computer-implemented method” and “a controller” to perform the abstract steps. These components read on a computer-implemented system and method and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this limitation does not integrate the abstract ideas into a practical application because it does not impose any meaningful limits on practicing the abstract ideas.
Step 2B:
As discussed with respect to Step 2A, Prong 2, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in Step 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A, or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more
than what is well-understood, routine, conventional activity in the field. The specification in ¶[0045] and ¶[0046] does not provide any indication that the computer-implemented method and controller are anything other than generic, off-the-shelf computer components. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-11 and 13-20 further limit the abstract ideas already indicated in independent claims 1 and 12, and they are ineligible for the same reasons provided for claims 1 and 12 above.
For example, claims 4-5 and 15-16 further limit the abstract ideas already indicated in claims 1 and 12 with the recitations of equations for how to calculate an AFB value (Claims 4/15) and EB values (Claims 5/16). These limitations pertain to mathematical relationships, equations, and calculations, as they further specify how the calculations recited in claims 1 and 12 are performed.
For these reasons, there is no inventive concept in the claims, and thus they are ineligible.
Examiner’s Note
The Examiner notes that while no prior art has been applied, claims 1-20 are not indicated as allowable due to the pending 101 rejections of claims 1-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bouguerra et al. (WIPO Pub. No. 2020/061409) discloses systems and methods for processing and presenting arrhythmia information that involves detecting ECG data, detecting atrial fibrillation events, calculating AF burden, and outputting a graphical representation of patient event data (Abstract).
Paamand et al. (EP 4008254) discloses a method for classifying atrial fibrillation by analyzing ECG data and determining AF complexity (Paragraphs 0001-0008).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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.
/H.A.H./Patent Examiner , Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights