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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a method of using an oximeter to measure oxygen saturation values at multiple depths, classified in A61B5/1455.
II. Claims 17-20, drawn to a method for replacing a sensor tip of a handheld oximeter, classified in A61B5/14552.
Inventions I and II are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design, mode of operation, function, or effect. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Melvin Chan on 11/25/2025, a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 1-16 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 claims 1 and 10 is/are also rejected due to said dependency. In regard to claims 1 and 10, the claims recite “emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory… emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance”. It is unclear whether the two appearances of “a threshold distance” are the same or different threshold distance(s) and the two appearances of “the threshold distance” refer to the same or different threshold distance(s). Clarification is requested by amendments.
In regard to claims 3 and 12, the claim recites “the first/ second tissue”. Claims 1 and, which claims 3 and 12 depend from, recites “first/ second tissue of the tissue… a first/ second tissue region”. First of all, “the first/ second tissue” lacks of sufficient antecedent basis. Secondly, it is unclear whether “the first/ second tissue” refers to “first/ second tissue of the tissue” or “first/ second tissue region” or additional tissue(s). Clarification is requested by amendments.
In regard to claim 8, the claim recites “allowing + step/ function”. It is unclear whether the step/function recited after “allowing” is required to be performed or merely an intended use(s) with insufficient patentable weight(s) since the word “allowing” is not considered as a positive claim language. Clarification is requested by amendments.
In regard to claim 10, the claim recites “the oximeter comprises a processor, memory, display, power source, and probe tip… inserting and enclosing the oximeter into a probe cover, wherein the probe…”. First of all, “the probe” lacks sufficient antecedent basis. Secondly, it is unclear whether “the probe” refers to “probe tip” or “prove cover” or additional probe(s). Clarification is requested by amendments.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bechtel et al. (USPGPUB 2014/0046152 – applicant cited). In regard to claim 1, Bechtel discloses a method (Figs. 1-20 and associated descriptions) comprising: providing an oximeter (Figs. 1-7 and associated descriptions) comprising a processor (processors, Figs. 4 and 6and associated descriptions), memory (element 205, Figs. 4 and 6 and associated descriptions), display (element 125, Fig. 4 and 6 and associated descriptions), power source (battery, Figs. 1 and 6 and associated descriptions), and probe tip (element 105C/250/300, Fig. 7C-G and associated descriptions) comprising a first source structure (elements 150a and/or 150b, Figs. 9A-B and associated descriptions) and a plurality of detector structures (elements 170a-e, Figs. 9A-B and associated descriptions), wherein the processor is coupled to the memory and display (Figs. 1, 4 and 6 and associated descriptions), and the power source is coupled to the processor, memory, and display (Figs. 1, 4 and 6 and associated descriptions); using the oximeter, determining an oxygen saturation of a tissue to be measured (Figs. 19-20 an d associated descriptions); emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance (steps 2000, 2005, 2010, and 2015, Fig. 20 and associated descriptions; [0229-0230]); fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory (step 2015, Fig. 20 and associated descriptions; [0229-0230]); determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses steps 2015/2025, Fig. 20 and associated descriptions; [0229-0230]); emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance (steps 2000, 2005, 2010, and 2020, Fig. 20 and associated descriptions; [0229-0230]; Steps 2000, 2005, and 2010 can be repeated for multiple wavelengths of light and for one or more other light sources, [0229]); determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance (steps 2000, 2005, 2010, and 2020, Fig. 20 and associated descriptions; [0229-0230]; Steps 2000, 2005, and 2010 can be repeated for multiple wavelengths of light and for one or more other light sources, [0229];The second portion of reflectance data is generated by the first portion of the light detectors and another light detector that is at the next largest source-to-detector distance from the light source compared to the threshold distance, [0230]); based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth (step 2035, Fig. 20 and associated descriptions; source-detector distances, Figs. 17 and 19-20 and associated descriptions; inherent properties of source-detector separation distances vs. measurement depths); and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth (steps 2025 and 2035, Fig. 20 and associated descriptions; Steps 2000, 2005, and 2010 can be repeated for multiple wavelengths of light and for one or more other light sources, [0229]; [0231-0232]).
In regard to claim 2, Bechtel discloses fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory (step 2020, Fig. 20 and associated descriptions; [0230]).
In regard to claim 4, Bechtel discloses the oximeter is a handheld device (Figs. 7A-7E and 8A-B and associated descriptions), and the power source is a battery (battery, Figs. 1 and 6 and associated descriptions).
In regard to claim 7, Bechtel discloses the detector structures have an average distance from the first source structure, and the threshold distance is the average distance ([0026-0027]; [0230]).
In regard to claim 8, Bechtel discloses allowing a user to select a tissue depth of the tissue to be measured for determining the first or second oxygen saturation (intended uses with insufficient patentable weights; referring to 35 USC 112(b) rejection above).
In regard to claim 9, Bechtel discloses the determining second measurement information comprises performing a sum of squares error calculation to determine a specific simulated reflectance curve that has the lowest fit error (Fig. 18 and associated description; sum of squares error calculation/ lowest fit error, [0203]).
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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel as applied to claims 1-2, 4 and 7-9 above, and further in view of Heaton et al. (USPN 8,938,279 – applicant cited). In regard to claims 5-6, Bechtel discloses all the claimed limitations except coupling a multiplexer circuit between the processor and the detector structures and coupling a multiplexer circuit to the processor; using the multiplexer circuit to route signals to the processor from the detector structures that are closer to the source structure than the threshold distance; and using the multiplexer circuit to not route signals to the processor from the detector structures that are farther from the source structure than the threshold distance.
Heaton teaches coupling a multiplexer circuit between a processor of a tissue oximetry system and the detector structures (element 2466, Fig. 24 and associated descriptions; tissue oximetry system, Figs. 2-3 and associated descriptions)) and coupling a multiplexer circuit to the processor; using the multiplexer circuit to route signals to the processor from the detector structures that are closer to the source structure than the threshold distance; and using the multiplexer circuit to not route signals to the processor from the detector structures that are farther from the source structure than the threshold distance (“The computer, via the multiplexer, controls which detectors to use to evaluate the reflected radiation. For example, the computer can control the control circuit to select the input of the multiplexer corresponding to detectors 2421-2422. Then, the received radiation at these detectors is transmitted through the multiplexer to the detector. The radiation received at other detectors is not transmitted because the multiplexer prevents or blocks their transmission”, Col 27 line 64 – Col 28 line 4).
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) to incorporate the multiplexer and associated functions/steps/elements as taught by Heaton since both devices are tissue oximetry systems and one of ordinary skill in the art would have recognized that the multiplexer as taught by Heaton facilitates control the detection signals from particular or set(s) of detectors with different source-detector separation distances for oximetry measurements at various depths (see Heaton). The rationale would have been to select desired detector signals for obtaining oximetry data at different measurement depths.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 21-27 of U.S. Patent No. 10,827,957. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9 and 21-27 of 957 anticipate or recite similar claim limitation as claims 1-16 of present application.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,707,214. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of ‘214 anticipate or recite similar claim limitation as claims 1-16 of present application.
Claims 10-11 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,722,156 in view of Bechtel. In regard to claims 10-11 and 13-14, Claim 1 of ‘156 recite all the claimed limitations except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery.
Bechtel teaches a method for operating an oximeter (Figs. 1-7 and 19-20 and associated descriptions) comprises except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery (referring to claims 1-2 and 4 above).
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 probe cover (claim 1 of ‘156) to incorporate the oximeter and associated functions/steps/elements as taught by Bechtel to be enclosed by the probe cover and perform the operations, since the probe cover as taught by claim 1 of ‘156 is for a oximeter with a display and optical emission/ detection tip and the oximeter as taught by Bechtel has corresponding configurations, one of ordinary skill on the art would have recognized that the sealed probe cover enclosure prevents contaminants to the enclosed oximeter (claim 1 of ‘156). The rationale would have been to prevents contaminants to the enclosed oximeter during operation.
Claims 10-11 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,583,211 in view of Bechtel. In regard to claims 10-11 and 13-14, Claims 1-2 of ‘211 recite all the claimed limitations except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery.
Bechtel teaches a method for operating an oximeter (Figs. 1-7 and 19-20 and associated descriptions) comprises except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery (referring to claims 1-2 and 4 above).
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 probe cover (claims 1-2 of ‘211) to incorporate the oximeter and associated functions/steps/elements as taught by Bechtel to be enclosed by the probe cover and perform the operations, since the probe cover as taught by claim 1-2 of ‘211 is for a oximeter with a display and optical emission/ detection tip and the oximeter as taught by Bechtel has corresponding configurations, one of ordinary skill on the art would have recognized that the sealed probe cover enclosure prevents contaminants to the enclosed oximeter (claims 1-2 of ‘211). The rationale would have been to prevents contaminants to the enclosed oximeter during operation.
Claims 10-11 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,064,241 in view of Bechtel. In regard to claims 10-11 and 13-14, Claims 1-3 of ‘241 recite all the claimed limitations except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery.
Bechtel teaches a method for operating an oximeter (Figs. 1-7 and 19-20 and associated descriptions) comprises except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery (referring to claims 1-2 and 4 above).
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 probe cover (claims 1-3 of ‘241) to incorporate the oximeter and associated functions/steps/elements as taught by Bechtel to be enclosed by the probe cover and perform the operations, since the probe cover as taught by claim 1-3 of ‘241 is for a oximeter with a display and optical emission/ detection tip and the oximeter as taught by Bechtel has corresponding configurations, one of ordinary skill on the art would have recognized that the sealed probe cover enclosure prevents contaminants to the enclosed oximeter (claim 1-3 of ‘241). The rationale would have been to prevents contaminants to the enclosed oximeter during operation.
Claims 10-11 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 12,383,171 in view of Bechtel. In regard to claims 10-11 and 13-14, Claims 1 and 3 of ‘171 recite all the claimed limitations except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery.
Bechtel teaches a method for operating an oximeter (Figs. 1-7 and 19-20 and associated descriptions) comprises except providing an oximeter to determine an oxygen saturation of a tissue to be measured, wherein the oximeter comprises a processor, memory, display, power source, and probe tip comprising a first source structure and a plurality of detector structures, the processor is coupled to the memory and display, and the power source is coupled to the processor, memory, and display; emitting first light by the first source structure into the tissue to be measured and detecting a reflection of the first light from the tissue by the detector structures that are closer to the source structure than a threshold distance; fitting first detector responses, generated by the detector structures that are closer to the source structure than the threshold distance based on the detected first light, to a plurality of simulated reflectance curves stored in the memory; determining first measurement information for first tissue of the tissue to be measured based on one or more best fitting ones of the simulated reflectance curve to the first detector responses; emitting second light by the first source structure into the tissue and detecting a reflection of the second light from the tissue by the detector structures that are farther from the source structure than a threshold distance; determining second measurement information for second tissue of the tissue to be measured based on the second light detected by the detector structures that are farther from the source structure than the threshold distance; based on the first measurement information, calculating and displaying on the display a first oxygen saturation measurement for a first tissue region below a surface of the tissue at a first depth; and based on the second measurement information, calculating and displaying on the display a second oxygen saturation measurement for a second tissue region below the surface of the tissue at a second depth; fitting second detector responses, that are generated by the detector structures that are farther from the source structure than the threshold distance based on the detected second light, to the plurality of simulated reflectance curves stored in the memory; the oximeter is a handheld device, and the power source is a battery (referring to claims 1-2 and 4 above).
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 probe cover (claims 1 and 3 of ‘171) to incorporate the oximeter and associated functions/steps/elements as taught by Bechtel to be enclosed by the probe cover and perform the operations, since the probe cover as taught by claim 1 and 3 of ‘171 is for a oximeter with a display and optical emission/ detection tip and the oximeter as taught by Bechtel has corresponding configurations, one of ordinary skill on the art would have recognized that the sealed probe cover enclosure prevents contaminants to the enclosed oximeter (claim 1 and 3 of ‘171). The rationale would have been to prevents contaminants to the enclosed oximeter during operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zuluage (USPGPUB 2013/0150729 – applicant cited) teaches a cover sleeve for a medical device (Fig. 1) comprises a first portion (element 10, Fig. 1) including an optical panel (element 30, Fig. 1) and a second portion (element 40, Fig. 1), wherein an opened end of the first portion is coupled to the second portion to form a sealed enclosure but the second portion does not contain a display reviewer window.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791