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 Objections
Claim 21 is objected to because of the following informalities: “ans” should be “and” as well as “kiniticardiography sensor subject” should delete “subject”. Appropriate correction is required.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 21-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13 and 14 of U.S. Patent No. 11,974,832. Although the claims at issue are not identical, they are not patentably distinct from each other because 832 recites more specific limitations in some cases. 832 also determines power for some cases and force or work in others however power is easily calculated from work.
Current claims
US 11,974,832
21
1, 12, 14
22
1, 12, 14
23
1, 12, 14
24
2
25
1, 12, 14
26
1, 12, 14
27
1, 12, 14
28
1, 12, 14
29
12, 13
30
1, 3
31
1, 12, 13
32
1, 12, 14
33
1, 3
34
1, 2, 3
35
1, 3
36
1, 12, 14
37
1, 2, 3
38
1, 12, 14
39
1, 3
42
1, 12, 14
43
9, 11
44
1, 12, 14
45
9, 11
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 24, 36, 43 and 45 and associated dependent claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 24 and 36 recite determining the total cardiac energy from a difference in maximum peaks in linear cardiac kinetic energy, in angular cardiac kinetic energy, or in total cardiac kinetic energy that are close to an end of an inspiration phase and maximum peaks in linear cardiac kinetic energy, in angular cardiac kinetic energy, or in total cardiac kinetic energy that are close to an end of an expiration phase, and/or - is extracted as a power of a continuous wavelet transform, CWT, at the respiration frequency, wherein the CWT is the transformation of a time series of beat-by beat values for linear cardiac kinetic energy, in angular cardiac kinetic energy, or in total cardiac kinetic energy and determining the respiratory variability in linear cardiac power, in angular cardiac power, or in total cardiac power is determined from a difference in: - maximum peaks in in linear cardiac power, in angular cardiac power, or in total cardiac power that are close to an end of an inspiration phase and maximum peaks in in linear cardiac power, in angular cardiac power, or in total cardiac power that are close to an end of an expiration phase, and/or - is extracted as a power of a continuous wavelet transform, CWT , at the respiration frequency, wherein the CWT is the transformation of a time series of beat-by beat values for linear cardiac power, in angular cardiac power, or in total cardiac power. Claims 43 and 45 recite providing instructions to the subject with breathing recommendations or stress management protocols.
The limitation of determining total cardiac energy and respiratory variability and providing instructions or recommendations, 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 “at least one processor” and outputting digital data (all of which include or involve generic computer components), the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, communications interface and output language, “determining” in the context of this claim encompasses the user manually calculating a difference and providing instructions or recommendations to the user. 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. Similarly, but for the processor, communications interface and output language, “providing” in the context of this claim encompasses the user and providing instructions or recommendations to the user. If a claim limitation, under its broadest reasonable interpretation, covers a limitation that manages interaction between people but for the recitation of generic computer components, then it falls within the “Certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a kineticardiography sensor. The sensor involves mere data gathering and amounts to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and implied output device are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. 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 claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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 26 and 31 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. It is unclear how respiratory is determined from a difference in the extracted as a power of a CWT. It seems the CWT is an alternative to determining a difference in the maximum peaks but the claim does not make this clear. It seems the preamble should not include “is determined from a difference in” as that is part of the maximum peaks step.
Claims 35 is 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. The claim recites “sum of linear energy values” and “sum of angular energy values” but there is no mention of these values being collected in the preceding claims so it is unclear what values are being referred to. Similarly, linear energy values and angular energy values could refer to any linear or angular energy and it seems this is only in reference to cardiac energy measured by the sensor not all energy of the body. The same issue is present for the linear power and angular power recitations.
Claim 36 is 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. It is unclear how respiratory is determined from a difference in the extracted as a power of a CWT. It seems the CWT is an alternative to determining a difference in the maximum peaks but the claim does not make this clear. It is also unclear which steps of the claim are alternatives as multiple and/or are used.
Claim 37 is 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. It is unclear if the claim is reciting that the systolic and diastolic blood pressure values are part of or determined from the angular kinetic energy or are just values that are part of the angular kinetic energy. The specification seems to state that the energy or other kineticardiography components are determined over the systolic and diastolic phases of the heart beat but the claim is not clear as is.
Claims 24, 29 34 and 39 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. It is not clear where the moments of inertia come from. When are they calculated?
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 21, 40-42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meriheina et al. WO 2015/036925 (cited IDS filed 4/3/24) in view of Heneghan et al. US 2010/0204550.
Regarding claim 21, Meriheina discloses a multi-dimensional kineticardiography kit for detecting one or more parameters including respiratory variability of a subject, the kit comprising:
at least one kineticardiography sensor configured for attachment to a subject to detect movement of the subject in response to -respiratory motion, and - at least one heart beat in six dimensions, wherein the six dimensions include three linear components and three rotational components, and to produce kineticardiography sensor signals indicative of the detected movement ([pg. 3 lines 11 – pg. 4 line 7][pg. 13 lines 19-27] Meriheina uses a ballistocardiogram that measurements angular movements as well, which according to Applicant’s definition in their specification constitutes a kineticardiogram);
at least one processor configured to be connected to said at least one kineticardiography sensor to receive and process at least said kineticardiography signals for each of said six dimensions from said at least one kineticardiography sensor subject ([pg. 13 lines 9-27]); and
Meriheina does not specifically disclose wherein the at least one processor is configured for calculation of respiratory variability from the kineticardiography sensor signals. Heneghan teaches a similar ballistocardiogram device that determines respiratory variability from the chest movement measurements ([¶55]). Therefore it would have been obvious to one of ordinary skill in the art at the time of invention to combine the device of Meriheina with the respiratory variability monitoring of Heneghan in order to monitor chronic disease ([¶55]).
Regarding claim 40, Meriheina discloses the at least one kineticardiography sensor comprises accelerometers and gyroscopes ([pg. 13 lines 19-27]).
Regarding claim 41, Meriheina discloses the at least one kineticardiography sensor is comprised in a single unit, or in two or more units ([FIG1] monitoring system 200).
Regarding claims 42 and 44, Heneghan teaches a kit for medical monitoring of a subject comprising the multi-dimensional kineticardiography configured to detect one or more parameters including respiratory variability of the subject ([¶55]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20150094552 to Golda disclosing CWT .
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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