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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 27, 2025 has been entered. By this amendment, claims 1, 2, 8, 15, 16, and 19 are amended, claims 6, 7, 10, 11, and 20 are cancelled, claims 21-30 are added, and claims 1, 2, 4, 8, 12-16, 19, and 21-30 are now pending in the application.
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 2, 8, and 19 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 2 recites the limitation "the data" in line 6. It is unknown if this recitation is referring to the previously recited “ECG data” or the previously recited “package of data”. Clarification is requested.
Claim 8 recites the limitation "the Holter report" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the second report" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 2, 4, 8, 12-16, 19, and 21-30 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. More specifically, these claims are directed to the mental process (i.e., abstract idea) of collecting and processing health data and providing a notification based on results of that processing.
Concerning Revised Step 2A, Prong One (whether the claim recites a judicial exception), please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
using an algorithm for determining the optimal number of visits by a business representative to a client, In re Maucorps, 609 F.2d 481, 485, 203 USPQ 812, 816 (CCPA 1979);
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016);
organizing information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1349, 111 USPQ2d 1717, 1720 (Fed. Cir. 2014);
Diagnosing an abnormal condition by performing clinical tests and analyzing the results, In re Grams, 888 F.2d 835, 840, 12 USPQ2d 1824, 1828 (Fed. Cir. 1989); see CyberSource, 654 F.3d at 1372 n.2, 99 USPQ2d at 1695 n.2 (describing the abstract idea in Grams).
The steps of detecting cardiac events, determining a severity of the detected events, and determining rhythm classifications of events carried out in Applicant’s claims are akin to a mental process because they are the type of determinations that could theoretically be carried out mentally (e.g., by a doctor), but are merely implemented using generic processing technology (presumably for the benefits of increased processing speed, convenience, accuracy, etc.). The 2019 revised § 101 guidance makes clear that the “mental process” category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing technology (see Footnotes 14 and 15 of the 2019 Revised Patent Subject Matter Eligibility Guidance).
Concerning Revised Step 2A, Prong Two (if the claim recites a judicial exception, evaluate whether the judicial exception is integrated into a practical application) the claims here do not integrate the abstract idea into a practical application because the claims are directed to a general algorithm which performs comparison on collected data, the algorithm being implemented on generic, already well-known technology. The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Merely using a computer to perform an abstract idea, e.g., applying the functionality of a computer and bar code system in the context of processing returned mail, Return Mail, Inc. v. U.S. Postal Service, -- F.3d --, --, -- USPQ2d --, -- slip op. at 33 (Fed. Cir. August 28, 2017);
Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential); and
Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
Applicant’s invention is essentially a computer-implemented automation of the standard medical diagnostic or analytical process. There is no “improvement” to the technology being used because, in fact, Applicant’s claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant’s claimed invention uses the claimed technology for its standard, well-known purpose, e.g., known generic processing circuitry is used to perform data calculations/comparisons, known outputs are used to output data which they are known to be capable of outputting, etc. Applicant’s invention does not result in improved performance of the processing circuitry, outputs, etc.
Accordingly, the only limitations beyond the abstract idea itself amount to implementing the abstract idea using generic computing technology (which is not sufficient to amount to a practical integration) and collecting and outputting the data required to carry out the abstract idea, which amounts to insignificant extra-solution activity and is also insufficient to amount to a practical application.
Concerning Step 2B, in addition to the relevant discussion in Step 2A, prong two above, please note, as explained in MPEP § 2106.05(I)(A), limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 134 S. Ct. at 2359-60, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g));
Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h))
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are well-known, routinely-used generic devices. Those devices, as recited in the claims, are:
A server
Processor
Computer-readable storage medium
All of the items listed above are extremely well-known, routine, conventional devices commonly used in the medical diagnostic arts. The examiner further notes that it need not be shown that the claimed elements were well-known specifically for carrying out all of the applicant’s claimed processing steps. Even if a mental process is new, it still merits rejection under 35 USC 101 if it is merely carried out using otherwise generic and well-known technology, e.g., a generic processor operating with a generic server. That it is, it need not be shown that, “a server that carries out these particular features is well known,” rather, it must merely be shown that the “additional” elements beyond the associated mental process are well known. In this case, the elements such as “processing circuitry” and “a storage medium” are clearly well known.
Regarding dependent claims 2, 4, 8, 12-14, 16, 19, and 21-30, the limitations further define the limitations already indicated as being directed to the abstract idea.
Response to Arguments
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796