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 .
Applicant’s preliminary amendments filed on 01/27/2025 are acknowledged.
Claims 2-21 are pending for examination.
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 2-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 2-12 recite a monitor, which fall within one of statutory categories (i.e. machine) (Step 1: YES).
Step 2A Prong One analysis: Claim 2 recites “combine the first and second one or more output detector signals into combined data prior to feeding the combined data into a single algorithm to generate a single measurement of a physiological parameter.”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claim 12 recites “a first sensor interface, a second sensor interface and one or more signal processors”. Claims 12 and 9-10 further recite “a first sensor, a second sensor, a plurality of light emitters, and a plurality of light detectors”. This judicial exception is not integrated into a practical application because the monitor merely comprises sensor interfaces for receiving data and processor(s) for processing data. It is noted that the first/second sensors/ emitters/ detectors are not positively recited and are not considered as parts of the monitor. Thus, there is no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the receive/ output functions associated with the sensor interfaces are considered as data gathering/ outputting functions to be insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C). And/ or the abstract idea (mental process) is directed as “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea” (see MPEP 2106.04(a)(2).III.B). (Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). The dependent claims 3-12 further limit the judicial exception and/or are reciting elements that are well understood, routine, and conventional. Therefore claims 1-20 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-3, 5, 7-14, 16, and 18-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Laakkonen (USPGPUB 2007/0149865). In regard to claims 2 and 13, Laakkonen discloses a noninvasive physiological monitor (Figs. 1-12 and associated descriptions), comprising: a first sensor interface (elements 131-n/14/15/161-n , Figs. 1 and 9-10 and associated descriptions) in communication with a first sensor adapted to be positioned at a first measurement site of a patient (one of elements 121-n , Figs. 1 and 9-10 and associated descriptions), the first sensor interface configured to (i) receive first one or more signals responsive to light of at least a plurality of wavelengths attenuated by tissue at the first measurement site (e.g. R and IR data form sensor 1 or 2, Figs. 3 and 11 and associated descriptions), the first one or more signals outputted by one or more optical detectors of the first sensor (one of elements 221-n associated with sensor 1 or 2, Figs. 1-3 and 9-11 and associated descriptions, and (ii) output first one or more output detector signals responsive to the first one or more signals (e.g. R and IR data form sensor 1 or 2, Figs. 3 and 11 and associated descriptions); a second sensor interface in communication with a second sensor adapted to be positioned at a second measurement site of the patient (the other one of elements 121-n , e.g. sensor 3, Figs. 1 and 9-10 and associated descriptions), the second measurement site different from the first measurement site (Figs. 1-3 and 9-10 and associated descriptions), the second sensor interface configured to (i) receive second one or more signals responsive to light of at least a plurality of wavelengths attenuated by tissue at the second measurement site (e.g. R and IR data form sensor 3, Figs. 3 and 11 and associated descriptions), the second one or more signals outputted by one or more optical detectors of the second sensor (the other one of elements 221-n associated with sensor 3, Figs. 1-3 and 9-11 and associated descriptions), and (ii) output second one or more output detector signals responsive to the second one or more signals (e.g. R and IR data form sensor 3, Figs. 3 and 11 and associated descriptions); and one or more signal processors (elements 10, 24 and/or 25, Figs. 1-3 and 9-10 and associated descriptions) configured to receive the first and second one or more output detector signals (Figs. 3 and 11 and associated descriptions) and combine the first and second one or more output detector signals into combined data (element 24 outputs combined data stream from the sequential sensor data, Figs. 3 and 11 and associated descriptions) prior to feeding the combined data into a single algorithm to generate a single measurement of a physiological parameter (pulse oximeter, abstract; pulse oximetry [0002-0007]; [0015]; [0036]).
In regard to claims 3 and 14, Laakkonen discloses the first or second one or more output detector signals comprising one or more of raw, demodulated, filtered, or converted-to-digital data (Figs. 3 and 11 and associated descriptions).
In regard to claims 5 and 16, Laakkonen discloses the first and second measurement sites comprise different types of body tissues (Figs. 1 and 9-10 and associated descriptions; tissue sites, [0008-0010]; multiple tissue sites, [0033-0034]).
In regard to claims 7-8 and 18-19, Laakkonen discloses the second measurement site is a peripheral site of the patient or the patient's finger (Fig. 10 and associated descriptions).
In regard to claims 5 and 16, Laakkonen discloses the first and/or second sensor comprises a plurality of light emitters configured to emit optical radiation onto the tissue of the first and/or second measurement sites
In regard to claim 9, Laakkonen discloses the first and/or second sensor comprises a plurality of light emitters configured to emit optical radiation onto the tissue of the first and/or second measurement sites (emitters in elements 121-n , Figs. 1-8 and 11 and associated descriptions).
In regard to claim 10, Laakkonen discloses the first and second sensor comprises a plurality of light detectors configured to detect light attenuated by the tissue of the first and/or second measurement sites (elements 221-n associated with sensor 1 or 2 or 3, Figs. 1-3 and 9-11 and associated descriptions).
In regard to claims 11 and 20, Laakkonen discloses the physiological parameter comprises oxygen saturation, methemoglobin, carboxyhemoglobin, total hemoglobin, and/or glucose (pulse oximeter, abstract; pulse oximetry [0002-0007]; [0015]; [0036]; SpO2, Figs. 1 and 9-10 and associated descriptions).
In regard to claims 12 and 21, Laakkonen discloses the combined data comprises one or more of a ratiometric value, non-normalized features, data from bulk absorption, or peripheral absorption signals (Figs. 2-3, 7 and 10-11 and associated descriptions; attenuation, [0002] and [0015-0016]).
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 4, 6, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Laakkonen as applied to claims 2-3, 5, 7-14, 16, and 18-21 above, and further in view of Al-Ali et al. (USPN 6,334,065). In regard to claims 4 and 15, Laakkonen discloses all the claim limitations except to map the combined data to empirical data to generate the single measurement.
Al-Ali teaches a stereo pulse oximeter system (Figs. 1-4 and associated descriptions) comprises a processor (element 150, Figs. 1A, 1B and 2 and associated descriptions), wherein the processor is configured to calculate R/IR ratio(s) and map the ratio(s) to empirical data to generate oxygen saturation values (Fig. 4 and associated descriptions) and average the oxygen saturation values or provide samples of the saturation values taken at regular time intervals (average or a trend of oxygen saturation values, Col 16 lines 8-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitor (Laakkonen) to incorporate the additional data process(es) and associated functions/ elements as taught by Al-Ali, since both devices are pulse oximetry systems and one of ordinary skill in the art would have recognized that additional process(es) of the combined data facilitate generating an average or a trend of detected oxygen saturation values (see Al-Ali). The rationale would have been to obtain an average or a trend of oxygen saturation values from multiple sensor data.
In regard to claims 6 and 17, Laakkonen as modified by Al-Ali discloses all the claimed limitations except the first measurement site is on or around the patient's head or the patient's nose. Al-Ali additionally teaches and sensor(s) can be attached on or around the patient's head or the patient's nose (a person’s ear, face, and nose, Col 5 lines 15-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the first measurement site with a measurement site on or around the patient's head or the patient's nose to yield predictable results, since one or ordinary skill in the art would have recognized that a person’s ear, face, and/or nose is/are alternative equivalent oximetry measurement sites (see Al-Ali). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
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 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,504,058. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-23 of ‘058 anticipate or recite similar limitations of claims 2-21 of present application.
Claims 2-3, 5-14 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-17 of U.S. Patent No. 12,232,888. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 and 10-17 of ‘888 anticipate or recite similar limitations of claims 2-3, 5-14 and 16-21 of present application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Banet et al. (USPGPUB 2006/0122520) teaches a vital sign monitoring system (Figs. 1-6 and associated descriptions) comprises a plurality of optical sensors/ modules in contact with different tissue sites of a finger (elements 4-11, Figs. 1-5 and associated descriptions), sensor interfaces (elements 26a-h, Fig. 4 and associated descriptions), wherein each sensor/ module includes R and IR LEDs and associated PD(s) which can be activated sequentially (Figs. 1-2 and 4-5 and associated descriptions) and a processor (elements 32/34/48, Figs. 4-5 and associated descriptions), wherein the processor combines the sequential data form each sensor and apply an algorithm to generate an optimal result for determining vital signs such as heart rate, pulse oximetry, and blood pressure (average, [0010]; [0021-0022]; [0024-0025]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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.
/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
Prosecution Insights