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 amendments and remarks filed on 08/05/2026 have been fully considered.
Claims 1-22 are pending for examination.
Claim Objections
Claim 13 is objected to because of the following informalities: In regard to claim 13, “the first and third value” recited in the displaying step should be set forth “the first and third values”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims that depend directly or indirectly from claims 1 and 11 is/are also rejected due to said dependency.
In regard to claims 1 and 11, the preambles of claims 1 and 11 recite “A method of determining viability of a tissue of a patient” and the body of the claims recite “displaying the percentage difference on a display of the oximeter device to aid in determining the viability of the tissue of the patient”. According to paragraph [0113] of the PGPUB, “The number of simulated reflectance curves stored in memory 117 may be relatively large and can represent nearly all, if not all, practical combinations of optical properties and tissue properties that may be present in real tissue that is analyzed for viability by oximeter probe 101”. Examiner cannot find adequate support(s) for “determining a viability of a tissue of a patient and displaying the percentage difference on a display of the oximeter device to aid in determining the viability of the tissue of the patient” in the specification or original claims.
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 and 11 is/are also rejected due to said dependency. In regard to claims 1 and 11, the preambles of claims 1 and 11 recite “A method of determining viability of a tissue of a patient” and the body of the claims recite “displaying the percentage difference on a display of the oximeter device to aid in determining the viability of the tissue of the patient”. First of all, it is noted that the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. The preambles of claims 1 and 11 are considered as intended uses which have insufficient patentable weights since the body of the claims do not recite any positive step(s) of implementing the scope of the claims. Secondly, the relationship(s) between the “displaying the percentage difference” and the “determining the viability of the tissue “ is/are not clearly recited. It is also unclear in what degree the displaying step can be utilized to “aid” the determination of the viability of the tissue. Third, the phrase “to aid” is passive/intended use language that has no limiting effect on the claimed method. The limitation merely implies an active method step (determining the viability of the tissue of the patient) but does not explicitly require such as step. It is unclear what limiting effect the limitation is intended.
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). It is noted that the claims are rejected as best understood, see the 35 USC 112(b) rejection above). In regard to claims 1-3 and 11-12, Bechtel teaches a method comprises transmitting, via a source structure of an oximeter probe of an oximeter device in contact with a target tissue, a first light at a first time into the target tissue (source structure(s), Figs. 9-11 and associated descriptions); detecting a first reflected light that is reflected from the target tissue by a plurality of detector structures of the oximeter probe (detector structures of the probe, Figs. 9-11 and associated descriptions); generating by the plurality of detector structures first reflectance data for the first reflected light detected by the plurality of detector structures (Figs. 9-11 and associated descriptions; 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 plurality of simulated reflectance curves from the fitting 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 plurality of 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 plurality of 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 plurality of 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]).
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 when the percentage difference is greater than a threshold percentage difference.
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, 10-11, and 13-15; differences between the measured regional oximetry and a baseline level, Fig. 14 and [0108]) when the percentage difference is greater than a threshold percentage difference (the Δbase% is displayed with the alarm when the Δbase% is greater than a delta limit or a delta caution range is/are, [0102-0105]).
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 with alarm 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, 10-11, 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 device then the percentage difference is greater than a threshold percentage difference (referring to claims 11-12 above).
In regard to claims 14 and 16, Bechtel as modified by Lin and Al-Ali discloses wherein the first and second target (and third) tissues are at a 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 target tissues 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 target tissues 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. 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.
Response to Arguments
Applicant’s arguments, see page 10 of Remarks, filed on 08/05/2026, with respect to claims 3 and 12-13 have been fully considered and are persuasive. The objections of claims 3 and 12-13 have been withdrawn. It is noted that claim 13 still contains a similar deficiency (see above).
Applicant’s arguments, see pages 10-14 of Remarks, filed on 08/05/2026, with respect to claims 1-22 have been fully considered and are persuasive. The 35 USC 101 and 112(b) rejections of claims 1-22 have been withdrawn.
Applicant’s arguments, see pages 17-18 of Remarks, filed on 08/05/2026, with respect to claims 1-2, 5, 7-12, and 17-22 have been fully considered and are persuasive. The filed TD has been approved on 08/30/2026. The DP rejections of claims 1-2, 5, 7-12, and 17-22 have been withdrawn.
Applicant's arguments filed 08/05/2026 have been fully considered but they are not persuasive. In regard to the 103 rejections, applicant alleged that the combination of Bechtel, Lin, Al-Ali and/or O'Reilly does not teach or suggest the amended claims. In response, the combination of Bechtel, Lin, Al-Ali and/or O'Reilly discloses the amended claims with respect to the best understood/ interpretation under 35 USC 112(b) rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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).
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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.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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