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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/4/2024 and 6/6/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation – 35 USC § 112(f)
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 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:
“evaluation unit adapted to” in claims 22 and 33, which has no corresponding structure described in the specification, and is only shown as a “black box” in the figures.
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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the claim term “evaluation unit adapted to” in claims 22 and 33 has been interpreted under 35 USC 112(f). The “evaluation unit” has no corresponding structure described in the specification, and is only shown as a “black box” in the figures. Therefore, the applicant has not provided written description for the corresponding structure of the evaluation unit as required by 35 USC 112(a) and 112(f).
Claims 23-32 are rejected based on their association with claim 22.
Claim Rejections - 35 USC § 112(b)
Claim limitation “evaluation unit adapted to” as recited in claims 22 and 33 invokes 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, as described above. Therefore, the claims are indefinite and are 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 23-32 are rejected based on their association with claim 22.
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 34-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 34 is directed to a process (Step 1 of MPEP 2106). The claim recites receiving data, identifying features within the data, mapping the data and outputting a signal indicative of a temporal distance. These limitations, as currently drafted, recite a process that covers performance of the limitations in the mind. Nothing in the claim precludes the steps from practically being performed in the mind. As a specific example, a user can receive data from an ECG readout and the user can identify features in the data, map the data and output/speak/think a signal indicative of a temporal distance. No tangible therapy or change in structure/operation is claimed. That is, the claim does not require actually doing anything tangible as a result of the extracting or providing or even specifically describing specialized circuitry or structures. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea (Step 2A in MPEP 2106).
This judicial exception is not integrated into a practical application. As described above, the claims do not attempt to apply the abstract idea to deliver treatment to a patient or to change operation of a device itself based on the determining or output. In particular, claim 34 recites no specific structural elements. Additionally, data gathering and its generic components have been deemed an “extra-solution activity” that does not amount to an inventive concept when the activity is well-understood and/or conventional (see MPEP 2106.05(g)). Accordingly, the lack of 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 (Step 2B of MPEP 2106).
Additionally, even if the claims invoked computers or other machinery merely as a tool to perform an existing process, this will generally not amount to significantly more than a judicial exception. See. e.g., Versata Development Group v, SAP America, 793 F.3d 1306, 1335, 115 USPG2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must “play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"). In this case, as described above, there are no additional computers, tools, structure, etc. recited in the claims. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, as no additional elements have been claimed. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B of MPEP 2106).
Furthermore, the applicant has not shown that the claimed apparatus is necessarily and inextricably rooted in any specific technologies. For example, in DDR Holdings it was found that the claimed subject matter was significantly more because the abstract method was not just applied on/using the internet but it changed how the internet itself worked. In this case, the applicant’s claims do not change the functioning of the recited device.
While it seems clear that there is not a particular machine required by the claims, it also appears that there is not a particular transformation, either. It has been held that manipulation or signal processing of data to produce new data is NOT a transformation CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360 (Fed. Cir. 1994)).
Finally claim 34 is analogous to the case Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) which contains the following analysis: Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea. Applicant should add some sort of active use to the claims, such as applying a SPECIFIC therapy or updating the functioning of the processor based on the determination/comparison.
Additional case law that is relevant to this analysis include Digitech (Organizing and manipulating information through mathematical correlations), and Grams (An algorithm for calculating parameters indicating an abnormal condition).
Therefore, the Examiner must conclude that claim 34 is directed to an abstract idea. Regarding dependent claims 35-43, the recited limitations fall under a mental process using the same rationale as above.
Regarding dependent claim 44, the claim recites that leads are used to collect the data. However, data gathering and its generic components have been deemed an “extra-solution activity” that does not amount to an inventive concept when the activity is well-understood and/or conventional (see MPEP 2106.05(g)). 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 (Step 2B of MPEP 2106).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using generic structures to perform certain functional language steps and/or to collect data amounts to no more than mere instructions to apply the exception using a generic computer component or to perform extra-solution activity in a conventional way. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, a generic “component” that has not been claimed with any specificity is considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception. The recited “components” have not been claimed with any specificity and are considered by the Examiner to be well-understood, routine and conventional in the art and thus cannot be considered significantly more than the judicial exception.
Furthermore, the Examiner takes Official Notice that the components broadly and generically disclosed and claimed in the current application are well-understood, routine and conventional in the art for receiving and processing cardiac signals.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 22-24, 26-28, 31-36, 38-40, 43 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunderson et al. (US 2006/0235476, hereinafter Gunderson).
Regarding claims 22, 23, 31-35, 40, 43 and 44, Gunderson disclose a device and method for monitoring R-waves, which the applicant’s specification defines as equivalent to “R-triggers.” ECG/cardiac signals are detected using the leads shown in figures 3 and 4. An evaluation unit 224 is adapted to temporally identify R-waves from a far field cardiac signal FF EGM with R-waves/triggers VS-FF (“first data set”) over a predetermined time period and to receive a near field cardiac signal NF EGM with R-waves/triggers VS-NF (“second data set”), and to map the second data set onto the first data set (see figures 10 and 11, par. 0083-0084). Based on temporal distances of the VS-NF events from the VS-FF events, an output is provided as a warning of no oversensing, lead failure oversensing, TWOS, RWDC or oversensing from another source (see figure 10, par. 0083-0084).
Regarding claims 24 and 36, as seen in figure 9, an ECG signal includes stimulated portions (i.e., QRS wave) and non-stimulated portions (i.e., flat portion of the ECG).
Regarding claims 26, 27, 38 and 39, R-R intervals of consecutive cardiac cycles must be determined before an output can be made (see figure 10, par. 0082).
Allowable Subject Matter
Claims 25, 29, 30, 37, 41 and 42 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), 35 U.S.C. 112(a) and/or 35 U.S.C 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892. US 20230420123 and its parent application PCT/EP2021/071695 appear highly relevant but are not prior art due to 102(b)(2) exceptions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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