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
Claims 1, 7-9, 13-15, 19, and 20 are objected to because of the following informalities:
Regarding claims 1, 9, and 15, the phrase “representing of one of” (line 6 of claim 1, line 10 of claim 9, line 13 of claim 15) should be amended to read “representing one of”;
In each of claims 7, 8, 13, 14, 19, and 20, the comma after the first “comprises” term should be replaced with a colon;
The comma after the phrase “at least to” in line 5 of claim 9 should be replaced with a colon;
The comma after the term “comprising” in line 5 of claim 15 should be replaced with a colon;
The comma after the phrase “at least to” in line 9 of claim 15 should be replaced with a colon.
Appropriate correction is required.
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 5-8, 13, 14, 19, and 20 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.
Regarding claim 5, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 6, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 7, it is unclear what is meant by “configuring” the rates as respective ones of the multiple estimates. For the purpose of examination, claim 7 is being interpreted such that the determined rates are the multiple estimates. The same indefiniteness issue and interpretation apply to claims 13 and 19.
Regarding claim 8, it is unclear what is meant by “configuring” the average as the observed estimate of the vital sign. For the purpose of examination, claim 8 is being interpreted such that the average is the observed estimate of the vital sign. The same indefiniteness issue and interpretation apply to claims 14 and 20.
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 non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including conditioning acceleration signals, generating a conditioned acceleration magnitude signal, determining a first and/or second dataset, determining multiple estimates of a vital sign from the dataset(s), determining an observed estimate of the vital sign, and providing the observed estimate of the vital sign. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of (1) determining multiple estimates of a vital sign using one or both of a first dataset or a second dataset and (2) determining, using the multiple estimates, an observed estimate of the vital sign set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites providing the observed estimate of the vital sign, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The step of providing the observed estimate does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the provided observed estimate, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of conditioning acceleration signals, generating a conditioned acceleration magnitude signal, determining one or more of a first dataset indicative of peaks in the conditioned acceleration magnitude signal or a second dataset indicative of troughs in the conditioned acceleration magnitude signal, and providing the observed estimate of the vital sign. As noted above, the step of providing the observed estimate merely adds insignificant extra-solution activity to the judicial exception. Further, the conditioning, generating, and determining steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes the steps from well-understood, routine, and conventional data gathering and processing activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 9 and 15, the systems recited in the claims are generic systems comprising generic components configured to perform the Abstract Idea. The recited accelerometer device in claim 15 is a generic sensor configured to perform pre-solutional data gathering activity, and the at least one processor and at least one memory device of both claims make up a computer system configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps or functions pertaining to data gathering, routine data processing (e.g., detrending, filtering, determining time intervals between peaks, averaging), and the display of data. The conditioning, generating, determining, and providing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claims 15-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 15 improperly recites human tissue as part of the claimed invention. It is suggested that Applicant amend the claim to recite that the accelerometer device is configured to be mechanically coupled with a subject via a solid medium in order to remove the recitation of human tissue. Claims 16-20 are rejected due to their dependence on claim 15.
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.
Claims 1-4 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kinnunen et al.’108 (US Pub No. 2021/0228108) in view of Correa Ramirez et al.’887 (US Pub No. 2020/0178887 – cited by Applicant).
Regarding claim 1, Kinnunen et al.’108 discloses a computer-implemented method, the method comprising: receiving acceleration signals corresponding to respective acceleration channels of an accelerometer device mechanically coupled with a subject via a solid medium (sections [0059-0060], [0069-0070]); generating, using the acceleration signals, an acceleration magnitude signal representing one of pulmonary ventilation or blood circulation (sections [0077-0079] - the signal strength signal); determining, using the acceleration magnitude signal, one or more of a first dataset indicative of peaks in the acceleration magnitude signal, or a second dataset indicative of troughs in the acceleration magnitude signal (sections [0073], [0087]); determining, using one or both of the first dataset or the second dataset, an estimate of a vital sign of the subject (sections [0073], [0087]); and providing the determined estimate of the vital sign (sections [0063], [0065], [0102]).
Kinnunen et al.’108 discloses all of the elements of the current invention, as discussed above, except for the method comprising conditioning the acceleration signals to produce conditioned acceleration signals, wherein the acceleration magnitude signal is a conditioned acceleration magnitude signal.
Correa Ramirez et al.’887 teaches conditioning (detrending) acquired physiological signals in order to eliminate data due to gross movement before performing other analysis (section [0090]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kinnunen et al.’108 to include first conditioning the acquired acceleration signals, as this would eliminate data due to gross movement before performing subsequent analysis.
Kinnunen et al.’108 in view of Correa Ramirez et al.’887 discloses all of the elements of the current invention, as discussed above, except for determining multiple estimates of the vital signal of the subject and then determining an observed estimate of the vital sign from the multiple estimates.
Correa Ramirez et al.’887 teaches determining multiple estimates of a vital sign (heart rate/breathing rate) and then determining an observed estimate of the vital sign (average heart rate/average breathing rate) during a time period in order to remove noise or to provide a more representative value of the vital sign (section [0062]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kinnunen et al.’108 in view of Correa Ramirez et al.’887 to include determining, using one or both of the first dataset or the second dataset, multiple estimates of the vital sign, and determining, using the multiple estimates, an observed estimate of the vital sign, as this would provide a more representative vital sign estimate value.
Regarding claim 2, in the combination of Kinnunen et al.’108 in view of Correa Ramirez et al.’887, the observed estimate of the vital sign is presented on a display device (sections [0063], [0065], [0102] of Kinnunen et al.’108). One of ordinary skill in the art would have realized that the display is provided at a predefined presentation rate as displaying processed results at a predefined presentation rate is well known in the art.
Regarding claim 3, as modified by Correa Ramirez et al.’887, conditioning the acceleration signals comprises detrending a first accelerometer signal of the accelerometer signals (section [0090] of Correa Ramirez et al.’887).
Regarding claim 4, Kinnunen et al.’108 discloses that the conditioning further comprises filtering the first accelerometer signal (sections [0025], [0061], [0080]). As modified by Correa Ramirez et al.’887, a detrended accelerometer signal is filtered.
Regarding claim 7, Kinnunen et al.’108 discloses determining time intervals corresponding to respective consecutive peak-trough-peak triples (peak-to-peak intervals), with each one of the time intervals providing a respective rate associated with a respective vital sign, determines rates corresponding to respective inverses of the time intervals, and configuring the rates as respective ones of the multiple estimates (section [0073]).
Regarding claim 8, as modified by Correa Ramirez et al.’887, the observed estimate of the vital sign comprises combining at least a subset of the multiple estimates by determining an average of at least the subset of the multiple estimates over a defined moving time interval, and configuring the average as the observed estimate of the vital sign (section [0062] of Correa Ramirez et al.’887).
Regarding claims 9-20, the sections of Kinnunen et al.’108 cited above, as modified by Correa Ramirez et al.’887, disclose a system comprising an accelerometer device configured to generate the acceleration signals, the accelerometer device being mechanically coupled with a subject via a solid medium ( ); and a computing device comprising at least one processor and at least one memory device storing processor-executable instructions that, in response to execution by the at least one processor, individually or in combination, cause the computing device to perform the functions recited in the claims.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kinnunen et al.’108 in view of Correa Ramirez et al.’887, as applied to claim 4, further in view of Misaki’929 (US Pub No. 2019/0200929).
Kinnunen et al.’108 discloses that the vital sign is respiration rate (sections [0026], [0036], [0076]). Official notice is being taken that it is well known in the art to determine respiration rate based off of peaks identified in a physiological signal.
Kinnunen et al.’108 in view of Correa Ramirez et al.’887 discloses all of the elements of the claimed invention, as discussed above and in paragraph 9 above, except for the type of filtering that is performed on the first detrended accelerometer signal.
Misaki’929 teaches filtering a respiratory signal using a low-pass filter having a cutoff frequency of 0.2Hz (sections [0060] and [0063]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kinnunen et al.’108 in view of Correa Ramirez et al.’887 to include filtering the first detrended accelerometer signal by applying a low-pass filter having a cutoff frequency of 0.2 Hz, as it would merely be combining prior art elements according to known methods to yield predictable results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kinnunen et al.’108 in view of Correa Ramirez et al.’887, as applied to claim 4, further in view of Kanegae et al.’084 (US Pub No. 2019/0076084).
Kinnunen et al.’108 discloses that the vital sign is heart rate (sections [0026], [0036], [0076]).
Kinnunen et al.’108 in view of Correa Ramirez et al.’887 discloses all of the elements of the claimed invention, as discussed above and in paragraph 9 above, except for the type of filtering that is performed on the first detrended accelerometer signal.
Kanegae et al.’084 teaches filtering a heart rate signal using a bandpass filter having a lower cutoff frequency of about 1.0 Hz and a higher cutoff frequency of about 20 Hz (section [0079]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Kinnunen et al.’108 in view of Correa Ramirez et al.’887 to include filtering the first detrended accelerometer signal by applying a bandpass filter having a lower cutoff frequency of about 1.0 Hz and a higher cutoff frequency of about 20 Hz, as it would merely be combining prior art elements according to known methods to yield predictable results.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 16 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 19/064,616 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 1-4, 7-15, and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 19/064,616 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of the copending Application are narrower in scope than the claims of the current invention, encompassing the subject matter recited in the current claims. Any reference meeting the limitations set forth in claims 1-5 of the copending Application would also meet the limitations set forth in claims 1-4, 7-15, and 17-20 of the current invention. It is further noted that anyone in possession of the system of claims 1-5 of the copending Application would also be in possession of the method recited in claims 1-4 of the current invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Halperin et al.’443 (US Pub No. 2015/0164433) teaches applying a low-pass filter having a cutoff frequency of about 0.2Hz to a respiratory signal (section [0592]).
Sayadi et al.’627 (US Pub No. 2020/0163627 – cited by Applicant) discloses a method and system for determining a vital sign using acceleration signals acquired by an accelerometer device mechanically coupled with a subject via a solid medium.
Fonseca et al.’696 (US Pub No. 2016/0310696) teaches a method and system for determining a vital sign, wherein peaks and trough of an acquired physiological signal are used to determine the vital sign.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETSUB D BERHANU whose telephone number is (571)270-5410. The examiner can normally be reached Mon-Fri 9:00am-5:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights