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 .
Response to Arguments
1. Applicant's arguments filed 06/01/2026 have been fully considered but they are not persuasive. The Applicant argues that the claims could not be performed in the human mind, are not directed to an abstract idea, and that they provide a technical benefit to the art. The Examiner respectfully disagrees. The claims merely disclose gathering data and determining a PTT interval, then comparing this to posture, and determining a trend from this. Other than reciting the electrodes, EGM, accelerometer, and processor, nothing in the claimed elements precludes the step from practically being performed in the mind, given enough time. Applicant has provided no evidence (other than conjecture/opinion) that such a method cannot be performed in the human mind. The clam is also not integrated into practical application. They teach gathering data, classifying data, and then monitoring a trend. It is well established that the abstract idea alone cannot be considered the practical application/improvement.
MPEP 2106.05 states: An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016)… Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
MPEP 2106.05(a) states: it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.
The Applicant states that Par. 0041 of their specification discloses that PTT intervals can vary based on factors related to posture. This is not enough to prove that the combination of elements would provide a specific technical benefit by solving a known problem in continuous monitoring. In fact, US 20180235567 A1 teaches a correlation between PPT interval and posture (see Par. 0077), as does US 20170209053 A1 in Par. 0101. While these teachings do not disclose all the elements of the Applicant’s claims, they do suggest that it has been known in the art that PPT intervals and posture are related and should be accounted for when taking measurements.
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.
2. Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims 1, 15, and 20 recite a system/method for “determine[ing], based on the EGM signal and a photoplethysmography (PPG) signal, a plurality of pulse transit time (PTT) intervals occurring over the extended period of time; determine[ing], based on the accelerometer signal and for each PTT interval of the plurality of PTT intervals, a posture of a set of postures that the patient occupies during the respective PTT interval; classify[ing] each PTT interval of the plurality of PTT intervals to indicate the determined posture of the set of postures so that each posture of the set of postures is associated with one or more of PTT intervals of the plurality of PTT intervals; and monitor[ing] a trend of a patient condition over the extended period of time by monitoring the trend in the one or more PTT intervals associated with one or more postures of the set of postures.” This 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. That is, other than reciting the electrodes, EGM, accelerometer, and processor, nothing in the claimed elements precludes the step from practically being performed in the mind. For example, gathering data and determining a PTT interval and then comparing this to posture could be accomplished by the mind or by pen and paper. 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. Accordingly, the claim recites an abstract idea.
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 measure vital values of a subject or anything that can generate a model of data. Further, the use of electrodes/EMG and accelerometers as cited, are merely insignificant extra-solution activity of data gathering. 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 electrodes to sense EGM signals and the accelerometer to generate a signal, 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 electrodes to measure EGM values of a subject is well known in the art as disclosed by the following references: US 20080183083 A1 (Par 0012), US 20160256687 A1 (Par. 0079), and US 20190336077 A1 (Par. 0098) all disclose measuring EGM signals from electrodes to determine pulse transit times (PTT). Regarding the use of an accelerometer, this is also well known in the art as disclosed by the following references: US 20170340209 A1 (Par. 0115), US 20170281024 A1 (Abstract), and US 20170143216 A1 (Abstract) all disclose using an accelerometer to measure a signal and use that to determine a PTT. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11375905 B2 and of claims 1-20 of U.S. Patent No. 12121332 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the independent claims of US 11375905 B2 encompass the independent claims of the present application.
Prior Art Rejections
4. Claims 1-20 do not currently have any art rejections applied. The claims contain subject matter that is not found in the art. Such subject matter includes “determine[ing], based on the accelerometer signal and for each PTT interval of the plurality of PTT intervals, a posture of a set of postures that the patient occupies during the respective PTT interval; classify[ing] each PTT interval of the plurality of PTT intervals to indicate the determined posture of the set of postures so that each posture of the set of postures is associated with one or more of PTT intervals of the plurality of PTT intervals; and monitor[ing] a trend of a patient condition over the extended period of time by monitoring the trend in the one or more PTT intervals associated with one or more postures of the set of postures.” The U.S.C. 101 and Double Patenting rejections would need to be addressed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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