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 3 and 12-13 are objected to because of the following informalities: In regard to claims 3 and 12, “the first and second value” should be set forth “the first and second values”. In regard to claim 13, “the first and third value” should be set forth “the first and third values” Appropriate correction is required.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-22 recite methods, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claims 1 and 11 recite “fitting the first reflectance data to a plurality of simulated reflectance curves; determining one or more best fitting ones of the simulated reflectance curves from the fit of the first reflectance data to the plurality of simulated reflectance curves, wherein each of the simulated reflectance curves is associated with a value for an oximeter parameter; determining at least a first oximeter parameter for the one or more best fitting ones of the simulated reflectance curves to the first reflectance data; determining a first value for a first oximeter measurement based on the first oximeter parameter; determining a percentage difference between the first value and another value stored in a memory of the first oximeter”. 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: Claims 1 and 11 recite “an oximeter probe, a memory and a display”. This judicial exception is not integrated into a practical application because the oximeter probe and memory is unaffected by how the algorithms/ calculations/ determinations operate but merely data provider. 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 transmitting, detecting, generating, and displaying steps associated with the oximeter probe and the display are considered as data gathering and outputting steps to be insignificant extra-solution activity. 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/ outputting steps of insignificant extra-solution activity (see MPEP 2106.05(g)) 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). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 1-22 are ineligible.
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 1-22 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. Claims that depend directly or indirectly from claims 1, 3, 11-13, and 18 is/are also rejected due to said dependency. In regard to claims 1, 3 and 11-13, the claims recite “detecting first/second/third reflected light that is reflected from the target tissue by a plurality of detector structures of the oximeter probe; generating by the detector structures first/second/third reflectance data for the first/second/third reflected light detected by the plurality of detector structures. It is unclear whether “the detector structures” are the same or different detector structures as the recited “a/the plurality of detector structures”. Clarification is requested by amendments. If they are the same, it is suggested that “generating
In regard to claims 12-13, the claims contain conditional/ optional languages, “if”, which do not positively claim the limitations (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations recited after “if” are not given sufficient patentable weight. It is suggested that “when” or similar language should be set forth in order to more positively recite the limitations.
In addition to claims 12-13, the claims recite “the patient” which lacks of sufficient antecedent basis.
In regard to claims 18-19 and 22, the claims recite “a patient”. It is unclear whether “a patient” refers to the patient recited in claim 12 or a different patient. Clarification is requested by amendments.
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 1-6 and 11-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel et al. (USPGPUB 2014/0046152 – applicant cited) in view of Lin et al. (USPGPUB 2013/0225952 – applicant cited), and further in view of Al-Ali et al. (USPGPUB 2015/0099955 – applicant cited). In regard to claims 1-3 and 11-12,
Bechtel teaches a method comprises while an oximeter probe of an oximeter device contacts a target tissue (Figs. 1-8 and associated descriptions), transmitting first light at a first time from a source structure of the oximeter probe into the target tissue (source structure(s), Figs. 9-11 and associated descriptions); detecting first reflected light that is reflected from the target tissue by a plurality of detector structures of the oximeter probe (detector structures, Figs. 9-11 and associated descriptions); generating by the detector structures first reflectance data for the first reflected light detected by the plurality of detector structures (rejected as best understood, see the 35 USC 112(b) rejection above; Figs. 9-11 and associated descriptions) for generating reflectance for a tissue site (steps 1805, 1810, 1815, 1905, 1910 2005, and 2010, Figs. 18-20 and associated descriptions); and fitting the reflectance data to a plurality of simulated reflectance curves (steps 1820, 1915, 2015, and 2020, Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232]); determining one or more best fitting ones of the simulated reflectance curves from the fit of the reflectance data to the plurality of simulated reflectance curves (steps 1820 and 1915, Figs. 18-19 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232]), wherein each of the simulated reflectance curves is associated with a value for an oximeter parameter ([0192]; [0211]; [0232]); determining at least a first oximeter parameter for the one or more best fitting ones of the simulated reflectance curves to the first reflectance data (absorption coefficient, [0190] and [0192]; optical properties may include the absorption coefficient µa and the scattering coefficients µs, [0200]; Figs. 18A-18B; optical properties, steps 1920 and 1925, Fig. 19 and [0221-0223]; step 2030, Fig. 20 and [0232]); determining a first value for a first oximeter measurement based on the first oximeter parameter (oxygen saturation, [0210-0211]; [0223]; [0232]) and displaying the result on a display of the oximeter probe (display 125, Fig. 1 and associated descriptions; [0213]; [0223]; [0232]) and determining one or more best fitting ones of the simulated reflectance curves from the fit of the second reflectance data to the plurality of simulated reflectance curves; determining at least a second oximeter parameter for the one or more best fitting ones of the simulated reflectance curves to the second reflectance data; determining a second value for a second oximeter measurement based on the second absorption coefficient (the oximeter probe can be used to take oximetry measurements at different times/ locations, e.g. repeat, [0092-0093] and user operable switch 225, Fig. 5 and [0097-0098]; Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232]; see similar steps above ).
Bechtel does not specifically discloses determining and displaying a difference between the first and second values or the current value and a previous determined value on a display.
Lin discloses a method (Figs. 1-5 and associated descriptions) comprising: contacting a probe tip (element 12, Figs. 1-2 and associated descriptions) to a target tissue of a patient ( head, back, the stomach, the heel, the ear, an arm, a leg, or any other appropriate measurement site, [0017]); determining a first value for a first oximeter measurement based on a first reflectance data (first/ baseline regional oxygen saturation measurement in block 116, Figs. 2 and 4-5; oxygen saturation, [0028]; regional oxygen saturation, rSO2, [0032-0034]); storing the first value for the first oximeter measurement in the memory (blocks 94 and 118, Figs. 4-5 and associated descriptions; memory, abstract; memory, [0026] and [0033-0034]); performing second measurement (emitter 16, Figs. 1-2 and associated descriptions; second/ current measurement in block 126, Fig. 5 and [0034]); generating second reflectance data for the second reflected light detected by the detector structures (reflectance data detected by the detectors and/or data obtained after element 62 in Fig. 2 and [0027-0028], for the second/ current measurement in block 126, Fig. 5 and [0034]); determining a second value for a second oximeter measurement based on the second reflectance data (second/ current regional oxygen saturation measurement in block 126, Figs. 2 and 5; oxygen saturation, [0028]; regional oxygen saturation, rSO2, [0032-0034]); retrieving the first value from the memory (enable the same baseline 74 to be displayed on different monitors 14 located throughout the medical facility, [0032]; transmit/ receive the rSO2 values from the sensor 12, [0033-0034]); displaying a difference between the first and second values or the current value and a previous determined value on a display (the difference between lines 72 and 74, Fig. 3 and associated descriptions; “The steps described above may then be repeated when the patient is moved from the treatment room to a post-treatment room (e.g., intensive care unit or recovery room) or other room in the medical facility”, [0034]) if the percentage difference is greater than a threshold percentage difference (insufficient patentable weights, see the 35 USC 112(b) rejection above; Figs. 3-5 and associated descriptions).
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 methods (Bechtel) to incorporate the determining and displaying a difference between the first and second regional oxygen saturation or the current regional oxygen saturation and a previous determined regional oxygen saturation on a display as taught by Lin, since both devices are tissue oximetry sensors systems and one of ordinary skill in the art would have recognized that the comparison between current rSO2 and previous/ historical rSO2 provides more information of the patient before and after a medical procedure or moving from one room to another room in the hospital (see at least [0014-0015] and Fig. 5 and associated descriptions of Lin). The rationale would have been to better provide the change(s) of rSO2/ patient physiological condition before and after a medical procedure or moving from one room to another room in the hospital.
Bechtel as modified by Lin does not specifically disclose determining a percentage difference between the first and second value; and displaying the percentage difference on a display.
Al-Ali teaches a regional oximetry user interface (Figs. 5, 7, 10, and 13-15) comprises determining a percentage difference between the current rSO2 value and a baseline value and displaying the percentage difference on a display (Δbase%, Figs. 5, 7, 10, and 13-15; differences between the measured regional oximetry and a baseline level, Fig. 14 and [0108]).
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 method (Bechtel as modified by Lin) to incorporate the determination and display steps/ functions at taught by Al-Ali, since both methods are tissue oximetry monitoring processes and one of ordinary skill would have recognized that the determination and display functions as taught by Al-Ali provide a better numeric visual display of the difference between the current rSO2 value and a baseline value as compared to the user interpretation between two curves (see Lin). The rationale would have been to more efficiently display the difference between current rSO2 value and baseline value to the caregiver.
In regard to claim 4, Bechtel as modified by Lin and Al-Ali discloses the first oximeter measurement is a first oxygen saturation and the second oximeter measurements is a second oxygen saturation (oxygen saturation, [0210-0211]; [0223]; [0232] of Bechtel; rSO2, Fig. 5 and associated descriptions of Lin).
In regard to claim 5, Bechtel as modified by Lin and Al-Ali discloses the percentage difference is displayed as a numerical value (Δbase%, Figs. 5, 7, 10, and 13-15; differences between the measured regional oximetry and a baseline level, Fig. 14 and [0108] of Al-Ali).
In regard to claim 6, Bechtel as modified by Lin and Al-Ali discloses displaying the second value on the display (current value 72 and associated numeric value, Fig. 3 and associated descriptions of Lin; current rSO2 values in 1404/1408, Fig. 14 of Al-Ali).
In regard to claim 13, Bechtel as modified by Lin and Al-Ali discloses transmitting third light at a third time period from the source structure of the oximeter probe into third target tissue of the patient; detecting third reflected light that is reflected from the third target tissue by the plurality of detector structures of the oximeter probe; generating by the detector structures third reflectance data for the third reflected light detected by the plurality of detector structures; fitting the third reflectance data to the plurality of simulated reflectance curves; determining one or more best fitting ones of the simulated reflectance curves from the fit of the third reflectance data to the plurality of simulated reflectance curves; determining at least a third oximeter parameter for the one or more best fitting ones of the simulated reflectance curves to the third reflectance data; determining a third value for a third oximeter measurement based on the third oximeter parameter (the oximeter probe can be used to take oximetry measurements at different times/ locations, e.g. repeat, [0092-0093] and user operable switch 225, Fig. 5 and [0097-0098]; Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232] of Bechtel); retrieving the first value from the memory (the caregiver may be able to compare the current rSO.sub.2 data with the rSO.sub.2 baseline 74 determined while the patient was in the pre-treatment room. The steps described above may then be repeated when the patient is moved from the treatment room to a post-treatment room (e.g., intensive care unit or recovery room) or other room in the medical facility, [0034]; the sensor 12 may store several baselines 74 (e.g., pre-treatment baseline, treatment baseline, post-treatment baseline) and the caregiver may use the monitor 14 to select the appropriate one or more baseline 74 for viewing, [0035] of Lin); determining the percentage difference between the first and third value (current and one of data collected when the patient is in pre-treatment/ treatment/ post-treatment rooms, [0034-0035] of Lin) ; and displaying the percentage difference between the first and third value on a display of the oximeter probe (referring to claims 11-12 above) if the percentage difference is greater than a threshold percentage difference (insufficient patentable weights, see the 35 USC 112(b) rejection above; Figs. 3-5 and associated descriptions).
In regard to claims 14 and 16, Bechtel as modified by Lin and Al-Ali discloses wherein the first and second (and third) tissue are at the same location (repeat, [0092-0093] and user operable switch 225, Fig. 5 and [0097-0098]; Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232] of Bechtel).
In regard to claim 15, Bechtel as modified by Lin and Al-Ali discloses the first and second tissue are at the same location and the third tissue is at a different location (the oximeter can be utilized at the same or different tissue sites (the oximeter probe can be used to take oximetry measurements at different times/ locations, e.g. repeat, [0092-0093] and user operable switch 225, Fig. 5 and [0097-0098]; Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232]; of Bechtel; current vs historical values before/ after medical procedure or at different rooms, see Lin).
In regard to claim 17, Bechtel as modified by Lin and Al-Ali discloses the first and second tissue are at different locations (the oximeter probe can be used to take oximetry measurements at different times/ locations, e.g. repeat, [0092-0093] and user operable switch 225, Fig. 5 and [0097-0098]; Figs. 18-20 and associated descriptions; [0199-0209]; [0219-0224]; [0228-0232]; of Bechtel).
In regard to claims 18-19 and 22, Bechtel as modified by Lin and Al-Ali discloses measuring a melanin concentration of the first/ second target tissue of a patient and the oxygen saturation can again be determined ([0188-0192] of Bechtel) but does not specifically disclose adjusting the percentage difference between the first and second (or first and third) values based on the melanin concentration of the target tissue of a patient. However, Bechtel further discloses the melanin concentration of the target tissue would affect the tissue absorption coefficient, µa, and the oxygen saturation can again be determined. Therefore, one of ordinary skill in the art would have recognized that since the oxygen saturation can be updated/ calculated according to the melanin concentration of the target tissue, the difference percentage difference between the first and second (or first and third) values should be adjusted accordingly in order to obtain more accurate oxygen saturation values and associated differences of the tissue sites.
In regard to claim 20, Bechtel as modified by Lin and Al-Ali discloses wherein the percentage difference is a relative oxygen saturation value for a first oxygen saturation value and a second oxygen saturation value (Δbase%, Figs. 5, 7, 10, and 13-15; differences between the measured regional oximetry and a baseline level, Fig. 14 and [0108] of Al-Ali).
In regard to claim 21, Bechtel as modified by Lin and Al-Ali discloses the relative oxygen saturation value is unavailable for display until after the second time period and after the second oxygen saturation value has been determined (the Δbase% is unavailable for display when no current regional oxygen saturation has not been performed, see both Lin and Al-Ali).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bechtel, Lin and Al-Ali as applied to claims 1-6 and 11-22 above, and further in view of O'Reilly et al. (USPGPUB 2010/0099964 – applicant cited).
In regard to claims 7-10, Bechtel as modified by Lin and Al-Ali discloses all the claimed limitations except displaying an arrow on the display pointing in a downward direction to indicate the percentage difference has increased, wherein the arrow is red and displaying an arrow on the display pointing in an upward direction to indicate the percentage difference has decreased, wherein the arrow is green.
O'Reilly teaches an oximeter monitor (Fig. 5 and associated descriptions) comprises an indicator includes an up arrow, a down arrow and a hyphen bar to indicate up trending/prediction, down trending/prediction, or neutral trending/prediction and colors of red, yellow and green may be utilized in combination ([0081]).
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 method (Bechtel as modified by Lin and Al-Ali) to incorporate the indicators of up/ down arrows with assigned colors as taught by O'Reilly, since both user interfaces are for oximetry monitoring/ displaying and one of ordinary skill in the art would have recognized that arrows with colors can be utilized to better inform the caregiver the change/ trending directions of the physiological information (see O'Reilly). The rationale would have been to enhance visualization of the change/ trending directions of the information.
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 1-2, 5, 7-12, and 17-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,849,536. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘536 anticipate or recite similar limitations as claims 1-2, 5, 7-12, and 17-22 of precent application.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791