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 Interpretation
In regard to claim 8, the claim recites “a memory, wherein the memory stores data points for simulated reflectance curves, the simulated reflectance curves are used in determining an oxygen saturation value for an oxygen saturation measurement and an error value associated with the saturation measurement, and the quality metric is based on the error value”. It is noted that the limitation contains "nonfunctional descriptive materials", e.g. a memory stores “data points” and “an error value”, which do not have sufficient patentable weights. Applicant is reminded that the courts and Patent Office have distinguished between functional and non-functional descriptive materials stored on a memory device, see MPEP 2106.01 & 2111.05; Without further utilizing the stored values in a calculating/ processing element in a manner that would make the values functional, any system that comprises a memory and is capable of transferring the stored value to a device would be considered to meet the claim limitations. It is also noted that the processor recited in claim 16 performs a function using the stored data would make the stored data functional.
Claim Objections
Claims 1, 6, 8, 12, and 16 are objected to because of the following informalities:
In regard to claim 1, line 5, “is” should be set forth “are” and lines 12-13, “first the oxygen saturation” should be set forth “the first oxygen saturation value”.
In regard to claim 6, “a” should be set forth before “second oxygen saturation”.
In regard to claim 8,line 7, “a oxygen saturation” should be replaced by “an oxygen saturation”.
In regard to claim 12, “a oxygen saturation” should be replaced by “an oxygen saturation”.
In regard to claim 16, line 2, “an” should be deleted.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-7 recite a method, which fall within one of statutory categories (i.e. process) (Step 1: YES).
Step 2A Prong One analysis: Claims 31 and 42 recite “fitting the detector responses to data points for simulated reflectance curves to determine at least one absorption coefficient value for the tissue, and determining at least one error value associated with the fitting; using the at least one absorption coefficient value, determining a first oxygen saturation value for a first oxygen saturation measurement of a tissue; based on the at least one error value, determining at least one quality metric value for first the oxygen saturation value”. 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 1 recites “an oximeter device, comprising one or more sources and one or more detectors… displaying a visual indication…”. This judicial exception is not integrated into a practical application because the recited oximeter device is unaffected by how the calculations/ determinations operate (e.g. merely using a conventional oximetry device to collect data and provide data to the calculation/ determination steps). And the “using an oximeter device” and “displaying a visual indication“ steps are considered as data gathering and presenting steps to be insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed 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 (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/ presenting 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 1-7 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 1-7, 9-10, 12, and 16 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 claim 1 is/are also rejected due to said dependency.
In regard to claim 1, the claim recites “a plurality of detector responses are obtained for the reflected light; fitting the detector responses…”, wherein “the detector responses” lacks of sufficient antecedent basis. It is also unclear whether the detector responses refers to “a plurality of detector responses” or any additional response(s). Clarification is requested by amendments. If the first, it is suggested that “the plurality of detector responses” should be set forth.
In regard to claim 3, “the indication of the quality metric value” lacks of sufficient antecedent basis. It is also unclear whether “the indication of the quality metric value“ refers to “a visual indication of the quality metric value” or any additional indication(s). Clarification is requested by amendments. If the first, it is suggested that “the plurality of detector responses” should be set forth. Clarification is requested by amendments.
In regard to claim 4, “the quality metric value” lacks of sufficient antecedent basis. It is also unclear whether “the quality metric value “ refers to “at least one quality metric value” or any additional value(s). Clarification is requested by amendments. If the first, it is suggested that “the at least one quality metric value” should be set forth.
In regard to claim 5, the claim recites “using the at least one absorption coefficient value, determining a first oxygen saturation value for the tissue, wherein the quality metric value for the first oxygen saturation value is a first quality metric value”. First of all, the limitations of “using the at least one absorption coefficient value, determining a first oxygen saturation value for the tissue” appears to recited in claim 1. It is unclear whether the step is an additional step or a redundant limitation. Clarification is requested by amendments. Secondly, “the quality metric value” lacks of sufficient antecedent basis. It is also unclear whether “the quality metric value “refers to “at least one quality metric value” or any additional value(s). If the first, it is suggested that “the at least one quality metric value” should be set forth.
In regard to claim 7, “the quality metric value” lacks of sufficient antecedent basis. It is also unclear whether “the quality metric value “ refers to “at least one quality metric value” or any additional value(s). Clarification is requested by amendments. If the first, it is suggested that “the at least one quality metric value” should be set forth.
In regard to claims 9 and 10, the claims recites “the quality metric indicator represents a moving average of quality metric values” and “the quality metric indicator represents a percentage value via a bar graph”. It is noted that claim 8 which claims 9 and 10 depend, is a system claim and “a quality metric indicator” is interpreted as an element/ a hardware (e.g. a screen as recited in claim 12). However, the indicator recited in claims 9 and 10 is a number(s) or graph. It is unclear whether the quality metric indicator is a hardware or number(s)/ graph. Clarification is requested by amendments. If the first, it is suggested that “the quality metric indicator provides an indication of a value/ graph” or similar language should be set forth.
In regard to claim 12, “an oxygen saturation value indicator, wherein the oxygen saturation value indicator represents…”. Similar to the same deficiency as indicated in claims 9 and 10 above, it is unclear whether the oxygen saturation value indicator is a hardware or number(s). Clarification is requested by amendments.
In regard to claim 16, the claim recites “responses of one or more detectors”. It is unclear whether “one or more detectors” refers to the one or more detectors recited in claim 8 or an additional one or more detectors. Clarification is requested by amendments. If the first, it is suggest “the one or more detectors” should be set forth.
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 8 and 11-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ochs (USPGPUB 2015/0230758 – applicant cited). In regard to claim 8, Ochs discloses a system (Figs. 1-11 and associated descriptions) comprising: one or more sources (elements 130/316/402, Figs. 1 and 3-4 and associated descriptions) and one or more detectors (elements 140/142, 318/338, and/or 404/406, Figs. 1 and 3-4 and associated descriptions), wherein the system makes at least one oxygen saturation measurement of tissue (blood oxygen saturation, abstract; Figs. 3-11 and associated descriptions) by emitting light from the one or more sources into a tissue, and receiving light reflected by the tissue at the one or more detectors in response to the emitted light (Figs, 1-4 and associated descriptions); a quality metric indicator, wherein the quality metric indicator represents an indication of a quality metric associated with an oxygen saturation measurement (display 184 and/or speaker 186, Fig. 1 and associated descriptions; “display an indication of the low confidence measure (e.g., a warning or alert)…Rmin values may be displayed to indicate confidence or as a quality index”, [0097]); and a memory (element 174, Fig. 1 and associated descriptions; [0058]), wherein the memory stores data points for simulated reflectance curves, the simulated reflectance curves are used in determining an oxygen saturation value for an oxygen saturation measurement and an error value associated with the saturation measurement, and the quality metric is based on the error value (the limitations are directed to “nonfunctional descriptive materials” defined in the claim interpretation section above, which do not have sufficient patentable weights).
In regard to claim 11, Ochs discloses the quality metric indicator comprises a screen (display 184, Fig. 1 and associated descriptions).
In regard to claim 12, Ochs discloses an oxygen saturation value indicator, wherein the oxygen saturation value indicator represents the oxygen saturation value for an oxygen saturation measurement (display 184, Fig. 1 and associated descriptions; display rSO2, Fig. 6 and associated descriptions).
In regard to claim 13, Ochs discloses the oxygen saturation value and the quality metric are displayed on a screen (display 184, Fig. 1 and associated descriptions; display rSO2 and confidence 612, Fig. 6 and associated descriptions; [0097]).
In regard to claim 14, Ochs discloses a handheld oximeter probe comprises the system (elements 100/102; 314/312; and/or 400, Figs. 1-4 and associated descriptions).
In regard to claim 15, Ochs discloses a battery, coupled to the one or more sources and one or more detectors, quality metric indicator, and memory (battery, [0065] and battery, [0069]).
In regard to claim 16, Ochs discloses a processor (element 172, Fig. 1 and associated descriptions), wherein the processor determines the
In regard to claim 17, Ochs discloses the memory is a nonvolatile memory (memory types, [0058]).
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 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-16 and 18-20 of U.S. Patent No. 10,786,187. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 5-16 and 18-20 of ‘187 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Claims 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 and 20-21 of U.S. Patent No. 11,589,784. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4-18 and 20-21 of ‘784 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Claims 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-19 of U.S. Patent No. 11,800,999. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 10-19 of ‘999 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Claims 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 and 20-21 of U.S. Patent No. 12,070,311. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4-18 and 20-21 of ‘311 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Claims 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 and 20-21 of U.S. Patent No. 12,376,769. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4-18 and 20-21 of ‘769 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Claims 1-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 and 20-21 of U.S. Patent No. 12,376,769. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4-18 and 20-21 of ‘769 anticipated or recite similar claim limitations as claims 1-13 and 16-17 of present application.
Conclusion
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791