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
Applicant’s election without traverse of Group III and Species B in the reply filed on August 13, 2026 is acknowledged. Claims 1-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Claims 25-33 are presently under examination.
Claim Objections
Claims 25-31 are objected to because of the following informalities:
in claim 25, line 10: “of” should be inserted before “the third”;
in claim 25, line 12: “to” should be inserted before “the first”;
in claim 25, line 13: “a” should be inserted before “sensor head”;
in claim 25, line 13: “a distal end of the laparoscopic tube” should be “a distal end of the laparoscopic tube;” (note the added semicolon);
in claim 26, line 1: “The device” should be “The method”;
in claim 26, lines 1-2: “comprising providing the lower portion comprises” should be “the lower portion further comprises”;
in claim 27, line 3: “and the enclosure” should be deleted;
in claim 28, line 3: “and the enclosure” should be deleted;
in claim 29, line 2: “a” should be inserted before “wireless”;
in claim 30, line 1: “comprising providing” should be “wherein”;
in claim 30, lines 2-3: “light emitting diodes or laser diodes or photodetectors” should be “light emitting diodes, laser diodes, or photodetectors”; and
in claim 31, line 2: “an” should be inserted before “oxygen”.
Appropriate correction is required.
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 28 and 32-33 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.
Claim 28 recites “data optical measurement information” in lines 1-2; however, it is not clear if this recitation is the same as, related to, or different from the recitation “data optical measurement information” in claim 27, lines 1-2. The similar phraseology suggests that they are the same, but the lack of the definite article “the” suggests that they are different. If the recitations are the same, the present recitation should be “the data optical measurement information”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate clarification is required.
Claim 28 recites “a digital format an not an analog format” in line 3; which is grammatically awkward and generally unclear. It is not clear what relationship the “digital format” of this claim has to the recitation “a digital format” in claim 27, line 3. The recitation “an not an analog format” is not clear. Is the digital signal converted from an analog signal? Is this trying to recite “and not an analog format”, which would be redundant, as a digital format is not an analog format. Appropriate clarification is required.
Claim 32 recites the limitation “the first screen” in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a first screen” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 33 recites the limitation “the first screen” in line 1. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a first screen” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 33 recites the limitation “the oxygen saturation value” in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “an oxygen saturation value” would overcome this rejection. The claim is being read as such for the purposes of examination.
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.
Claim 25-26 and 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 19/444,121 (reference application, citing to claim set with the date 08/13/2026). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 25, copending claim 17 teaches a method (see claims 14 and 17) comprising:
providing a first device portion (see claim 14 ln. 3-11) comprising:
providing an upper portion of a sheath of the first device portion and a lower portion of the sheath of the first device portion (see claim 14 ln. 4);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (see claim 14 ln. 4-6);
providing a first opening in the lower portion at a distal end of the lower portion and a second opening in the lower portion at a proximal end of the lower portion (see claim 14 ln. 7-8);
providing a third opening in the upper portion at a distal end of the upper portion (see claim 14 ln. 9);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see claim 14 ln. 9-11);
coupling a laparoscopic tube the first opening of the lower portion at a proximal end of the laparoscopic tube (see claim 14 ln. 12-13); and
coupling sensor head to a distal end of the laparoscopic tube (see claim 14 ln. 14);
providing a second device portion (see claim 14 ln. 15-26) comprising:
providing an enclosure for the second device portion; providing an interior space inside the enclosure (see claim 14 ln. 16);
providing an electrical connector at a distal end of the enclosure (see claim 14 ln. 17);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (see claim 14 ln. 18-19);
providing a battery compartment, formed in the enclosure; covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see claim 14 ln. 20-21); and
providing a display coupled to the enclosure and the printed circuit board (see claim 14 ln. 22),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see claim 14 ln. 23-26).
Regarding Claim 26, copending claim 17 teaches the method of claim 25 as stated above. Copending claim 17 further teaches providing the lower portion comprises an electrical connector, and when the enclosure is within the sealed enclosed space, the electrical connector of the enclosure couples to the electrical connector of the lower portion (see claim 17 ln. 1-4).
Regarding Claim 29, copending claim 17 teaches the method of claim 25 as stated above. Copending claim 17 further teaches the electrical circuitry comprises a processor (see generally claim 14, the oximeter device capable of measuring oxygen saturation would necessitate a processor within the electrical circuitry, see ln. 18-19) and wireless communication circuit (see claim 14 ln. 31-33 the wireless connection from the oximeter device to the display device, which would necessitate a wireless communication circuit).
Regarding Claim 30, copending claim 17 teaches the method of claim 29 as stated above. Copending claim 17 further teaches providing the processor determines an oxygen saturation value (see generally claim 14, the oximeter device capable of measuring oxygen saturation would necessitate a processor within the electrical circuitry, see ln. 18-19), and
the enclosure does not include light emitting diodes or laser diodes or photodetectors (see claim 14 ln. 14, any such light emitting/detecting elements, i.e., sensor elements, would be in the sensor head, not the enclosure).
Claims 27-28 and 31-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 19/444,121 in view of Margiott et al. (US Patent Application Publication 2023/0225642), hereinafter Margiott. This is a provisional nonstatutory double patenting rejection.
Regarding Claim 27, copending claim 17 teaches the method of claim 26 as stated above. Copending claim 17 teaches to transfer information from lower portion to the enclosure through the electrical connectors (see claim 14 ln. 14 and 18-19, and claim 17 ln. 1-4, the measurement of the information at the sensor head would necessitate transfer to the processor in the device, through the taught electrical connectors).
Copending claim 17 does not specifically teach providing for data optical measurement information in a digital format.
Margiott teaches an oximetry device sealed in a sheath to make oximetry readings at multiple locations on the body (see abstract; Figs. 1-3 and 8-11), including with a laparoscopic oximeter (see ¶[0047] and ¶[0081]; Figs. 30-34). Margiott teaches a method (see abstract, ¶[0047], and ¶[0081] the oximetry device and readings; Figs. 1-3, 8-11, and 30-34) comprising:
providing a first device portion (¶[0107] the sheath 205; Figs. 8-10) comprising:
providing an upper portion of a sheath of the first device portion (¶[0107]-[0108] the lid 215; Figs. 8-10) and a lower portion of the sheath of the first device portion (¶[0107]-[0108] the body 220; Figs. 8-10);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (¶[0107]-[0108] the lid 215 is hinged to the body 220; Figs. 8-10);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0109] the sheath window 218; Fig. 9) and a second opening in the lower portion at a proximal end of the lower portion (¶[0107]-[0108] the opening of the body 220 about the seal 210; Figs. 8-10);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0107]-[0108] the opening of the lid 215 about the seal 210; Figs. 8-10);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see ¶[0107]-[0108] and Figs. 8-10, the mating of the lid 215 and the body 220 via the openings to make the sealed enclosed space, sealed via the seal 210);
coupling a laparoscopic tube to the sheath at a proximal end of the laparoscopic tube (¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303] the embodiments disclosed herein may be combined, which would include the laparoscopic tube 15 of the laparoscopic oximeter 5 and sheath 205 on the probe unit 10, via the various connectors including electrical, the laparoscopic tube 15 is coupled to the probe unit 10 via the proximal end; Figs. 30-34); and
coupling sensor head to a distal end of the laparoscopic tube (¶[0301]-[0302] the laparoscopic tube 15 includes an elongated tube 315 with a sensor head 25 on the distal end; Figs. 30-34);
providing a second device portion (¶[0052]-[0054] the system unit 301, ¶[0301] the probe unit 10, ¶[0047] the probe may be the system unit; Figs. 1-3 and 30-34) comprising:
providing an enclosure for the second device portion (¶[0052] the housing 705 and the power block 351; Figs. 1-3);
providing an interior space inside the enclosure (¶[0052] the various computing and sensing components within the housing 705, while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3);
providing an electrical connector at a distal end of the enclosure (¶[0055]-[0057] the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 4 and 30);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Fig. 4);
providing a battery compartment, formed in the enclosure (¶[0088] the power block 351 may include a battery module including one or more batteries 356; Fig. 4);
covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see Figs. 1-3, the power block 351 forms part of the exterior surface alongside the housing 705); and
providing a display coupled to the enclosure and the printed circuit board (¶[0052] the display 307, ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Figs. 1-4),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see Figs. 8-10, the system unit 301/the probe 20 is sealed within the sealed enclosed space of the sheath 205);
providing for data optical measurement information (¶[0302] the data from the sensor head 25 that emits light and collects reflected light is data optical measurement information) to transfer from the lower portion to the enclosure through the electrical connectors of the lower portion and the enclosure (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB), the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 1-4 and 30) in a digital format (¶[0278]-[0280] the real-time input may be a digital input from a digital circuit, such as via an analog-to-digital converter).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the light emitters/detectors of Margiott (which would generate the data optical measurement information) as the sensors in the copending claim 17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results (i.e., oxygen saturation measured via an optical modality) and/or (2) copending claim 17 requires a sensor modality for oxygen saturation measurement and Margiott teaches one such known modality for oxygen saturation measurement.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the digital format of Margiott as the data format in the modified copending claim 17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the digital format is a known format and would be required for processing of the data by the processor to yield the oxygen saturation measurements.
Regarding Claim 28, the modified copending claim 17 teaches the method of claim 27 as stated above. The modified copending claim 17 teaches providing for data optical measurement information (see Margiott ¶[0302] the data from the sensor head 25 that emits light and collects reflected light is data optical measurement information) to transfer from the lower portion to the enclosure through the electrical connectors of the lower portion and the enclosure (see Margiott ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB), the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 1-4 and 30) in a digital format an not an analog format (see Margiott ¶[0278]-[0280] the real-time input may be a digital input from a digital circuit, such as via an analog-to-digital converter).
Regarding Claim 31, copending claim 17 teaches the method of claim 29 as stated above. Copending claim 17 teaches the display of the oxygen saturation measurements (see claim 14 ln. 31-33), but not that displaying in a first screen of the display a numerical percentage of oxygen saturation value.
Margiott teaches an oximetry device sealed in a sheath to make oximetry readings at multiple locations on the body (see abstract; Figs. 1-3 and 8-11), including with a laparoscopic oximeter (see ¶[0047] and ¶[0081]; Figs. 30-34). Margiott teaches a method (see abstract, ¶[0047], and ¶[0081] the oximetry device and readings; Figs. 1-3, 8-11, and 30-34) comprising:
providing a first device portion (¶[0107] the sheath 205; Figs. 8-10) comprising:
providing an upper portion of a sheath of the first device portion (¶[0107]-[0108] the lid 215; Figs. 8-10) and a lower portion of the sheath of the first device portion (¶[0107]-[0108] the body 220; Figs. 8-10);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (¶[0107]-[0108] the lid 215 is hinged to the body 220; Figs. 8-10);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0109] the sheath window 218; Fig. 9) and a second opening in the lower portion at a proximal end of the lower portion (¶[0107]-[0108] the opening of the body 220 about the seal 210; Figs. 8-10);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0107]-[0108] the opening of the lid 215 about the seal 210; Figs. 8-10);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see ¶[0107]-[0108] and Figs. 8-10, the mating of the lid 215 and the body 220 via the openings to make the sealed enclosed space, sealed via the seal 210);
coupling a laparoscopic tube to the sheath at a proximal end of the laparoscopic tube (¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303] the embodiments disclosed herein may be combined, which would include the laparoscopic tube 15 of the laparoscopic oximeter 5 and sheath 205 on the probe unit 10, via the various connectors including electrical, the laparoscopic tube 15 is coupled to the probe unit 10 via the proximal end; Figs. 30-34); and
coupling sensor head to a distal end of the laparoscopic tube (¶[0301]-[0302] the laparoscopic tube 15 includes an elongated tube 315 with a sensor head 25 on the distal end; Figs. 30-34);
providing a second device portion (¶[0052]-[0054] the system unit 301, ¶[0301] the probe unit 10, ¶[0047] the probe may be the system unit; Figs. 1-3 and 30-34) comprising:
providing an enclosure for the second device portion (¶[0052] the housing 705 and the power block 351; Figs. 1-3);
providing an interior space inside the enclosure (¶[0052] the various computing and sensing components within the housing 705, while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3);
providing an electrical connector at a distal end of the enclosure (¶[0055]-[0057] the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 4 and 30);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Fig. 4);
providing a battery compartment, formed in the enclosure (¶[0088] the power block 351 may include a battery module including one or more batteries 356; Fig. 4);
covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see Figs. 1-3, the power block 351 forms part of the exterior surface alongside the housing 705); and
providing a display coupled to the enclosure and the printed circuit board (¶[0052] the display 307, ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Figs. 1-4),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see Figs. 8-10, the system unit 301/the probe 20 is sealed within the sealed enclosed space of the sheath 205);
displaying in a first screen of the display a numerical percentage of oxygen saturation value (¶[0112] the display 307 may show an oxygen saturation (StO2) percent value; Figs. 12-13).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the display format of Margiott with the display in the copending claim 17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results (i.e., the oxygen saturation displayed via a percentage) and/or (2) copending claim 17 requires the display of oxygen saturation, and Margiott teaches one such modality of oxygen saturation display.
Regarding Claim 32, copending claim 17 teaches the method of claim 29 as stated above. Copending claim 17 teaches the display of the oxygen saturation measurements (see claim 14 ln. 31-33), but not that displaying in the first screen of the display a battery level indication.
Margiott teaches an oximetry device sealed in a sheath to make oximetry readings at multiple locations on the body (see abstract; Figs. 1-3 and 8-11), including with a laparoscopic oximeter (see ¶[0047] and ¶[0081]; Figs. 30-34). Margiott teaches a method (see abstract, ¶[0047], and ¶[0081] the oximetry device and readings; Figs. 1-3, 8-11, and 30-34) comprising:
providing a first device portion (¶[0107] the sheath 205; Figs. 8-10) comprising:
providing an upper portion of a sheath of the first device portion (¶[0107]-[0108] the lid 215; Figs. 8-10) and a lower portion of the sheath of the first device portion (¶[0107]-[0108] the body 220; Figs. 8-10);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (¶[0107]-[0108] the lid 215 is hinged to the body 220; Figs. 8-10);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0109] the sheath window 218; Fig. 9) and a second opening in the lower portion at a proximal end of the lower portion (¶[0107]-[0108] the opening of the body 220 about the seal 210; Figs. 8-10);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0107]-[0108] the opening of the lid 215 about the seal 210; Figs. 8-10);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see ¶[0107]-[0108] and Figs. 8-10, the mating of the lid 215 and the body 220 via the openings to make the sealed enclosed space, sealed via the seal 210);
coupling a laparoscopic tube to the sheath at a proximal end of the laparoscopic tube (¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303] the embodiments disclosed herein may be combined, which would include the laparoscopic tube 15 of the laparoscopic oximeter 5 and sheath 205 on the probe unit 10, via the various connectors including electrical, the laparoscopic tube 15 is coupled to the probe unit 10 via the proximal end; Figs. 30-34); and
coupling sensor head to a distal end of the laparoscopic tube (¶[0301]-[0302] the laparoscopic tube 15 includes an elongated tube 315 with a sensor head 25 on the distal end; Figs. 30-34);
providing a second device portion (¶[0052]-[0054] the system unit 301, ¶[0301] the probe unit 10, ¶[0047] the probe may be the system unit; Figs. 1-3 and 30-34) comprising:
providing an enclosure for the second device portion (¶[0052] the housing 705 and the power block 351; Figs. 1-3);
providing an interior space inside the enclosure (¶[0052] the various computing and sensing components within the housing 705, while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3);
providing an electrical connector at a distal end of the enclosure (¶[0055]-[0057] the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 4 and 30);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Fig. 4);
providing a battery compartment, formed in the enclosure (¶[0088] the power block 351 may include a battery module including one or more batteries 356; Fig. 4);
covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see Figs. 1-3, the power block 351 forms part of the exterior surface alongside the housing 705); and
providing a display coupled to the enclosure and the printed circuit board (¶[0052] the display 307, ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Figs. 1-4),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see Figs. 8-10, the system unit 301/the probe 20 is sealed within the sealed enclosed space of the sheath 205);
displaying in the first screen of the display a battery level indication (¶[0112] the display 307 may show an indicator 1920 for an amount of available battery power in the battery; Figs. 12-13).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the available battery power indicator of Margiott with the display of the oxygen saturation in the copending claim 17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results (i.e., the oxygen saturation displayed alongside a battery indication); and/or (2) the battery level would alert the user as to how much power and approximate time left of usage of the device; and/or (3) battery level indicators are well known and conventional on displays.
Regarding Claim 33, copending claim 17 teaches the method of claim 29 as stated above. Copending claim 17 teaches the display of the oxygen saturation measurements (see claim 14 ln. 31-33), but not that displaying in the first screen of the display a bar level indication of the oxygen saturation value.
Margiott teaches an oximetry device sealed in a sheath to make oximetry readings at multiple locations on the body (see abstract; Figs. 1-3 and 8-11), including with a laparoscopic oximeter (see ¶[0047] and ¶[0081]; Figs. 30-34). Margiott teaches a method (see abstract, ¶[0047], and ¶[0081] the oximetry device and readings; Figs. 1-3, 8-11, and 30-34) comprising:
providing a first device portion (¶[0107] the sheath 205; Figs. 8-10) comprising:
providing an upper portion of a sheath of the first device portion (¶[0107]-[0108] the lid 215; Figs. 8-10) and a lower portion of the sheath of the first device portion (¶[0107]-[0108] the body 220; Figs. 8-10);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (¶[0107]-[0108] the lid 215 is hinged to the body 220; Figs. 8-10);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0109] the sheath window 218; Fig. 9) and a second opening in the lower portion at a proximal end of the lower portion (¶[0107]-[0108] the opening of the body 220 about the seal 210; Figs. 8-10);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0107]-[0108] the opening of the lid 215 about the seal 210; Figs. 8-10);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see ¶[0107]-[0108] and Figs. 8-10, the mating of the lid 215 and the body 220 via the openings to make the sealed enclosed space, sealed via the seal 210);
coupling a laparoscopic tube to the sheath at a proximal end of the laparoscopic tube (¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303] the embodiments disclosed herein may be combined, which would include the laparoscopic tube 15 of the laparoscopic oximeter 5 and sheath 205 on the probe unit 10, via the various connectors including electrical, the laparoscopic tube 15 is coupled to the probe unit 10 via the proximal end; Figs. 30-34); and
coupling sensor head to a distal end of the laparoscopic tube (¶[0301]-[0302] the laparoscopic tube 15 includes an elongated tube 315 with a sensor head 25 on the distal end; Figs. 30-34);
providing a second device portion (¶[0052]-[0054] the system unit 301, ¶[0301] the probe unit 10, ¶[0047] the probe may be the system unit; Figs. 1-3 and 30-34) comprising:
providing an enclosure for the second device portion (¶[0052] the housing 705 and the power block 351; Figs. 1-3);
providing an interior space inside the enclosure (¶[0052] the various computing and sensing components within the housing 705, while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3);
providing an electrical connector at a distal end of the enclosure (¶[0055]-[0057] the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 4 and 30);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Fig. 4);
providing a battery compartment, formed in the enclosure (¶[0088] the power block 351 may include a battery module including one or more batteries 356; Fig. 4);
covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see Figs. 1-3, the power block 351 forms part of the exterior surface alongside the housing 705); and
providing a display coupled to the enclosure and the printed circuit board (¶[0052] the display 307, ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Figs. 1-4),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see Figs. 8-10, the system unit 301/the probe 20 is sealed within the sealed enclosed space of the sheath 205);
displaying in the first screen of the display a bar level indication of the oxygen saturation value (¶[0112] the display 307 may show a quality metric 1915 for the oximetry information 1900, including the oxygen saturation; Figs. 12-13).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the display format of Margiott with the display in the copending claim 17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results (i.e., the oxygen saturation displayed via a percentage alongside the bar quality metric) and/or (2) copending claim 17 requires the display of oxygen saturation, and Margiott teaches one such modality of oxygen saturation display.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 25-33 are rejected under 35 U.S.C. 103 as being unpatentable over Margiott et al. (US Patent Application Publication 2023/0225642), hereinafter Margiott, and in view of OuYang et al. (US Patent Application Publication 2022/0142460), hereinafter OuYang.
Regarding Claim 25, Margiott teaches an oximetry device sealed in a sheath to make oximetry readings at multiple locations on the body (see abstract; Figs. 1-3 and 8-11), including with a laparoscopic oximeter (see ¶[0047] and ¶[0081]; Figs. 30-34). Margiott teaches a method (see abstract, ¶[0047], and ¶[0081] the oximetry device and readings; Figs. 1-3, 8-11, and 30-34) comprising:
providing a first device portion (¶[0107] the sheath 205; Figs. 8-10) comprising:
providing an upper portion of a sheath of the first device portion (¶[0107]-[0108] the lid 215; Figs. 8-10) and a lower portion of the sheath of the first device portion (¶[0107]-[0108] the body 220; Figs. 8-10);
coupling the upper and lower portions of the sheath with a hinge, such that the upper and lower portions can rotate relative to each other by the hinge (¶[0107]-[0108] the lid 215 is hinged to the body 220; Figs. 8-10);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0109] the sheath window 218; Fig. 9) and a second opening in the lower portion at a proximal end of the lower portion (¶[0107]-[0108] the opening of the body 220 about the seal 210; Figs. 8-10);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0107]-[0108] the opening of the lid 215 about the seal 210; Figs. 8-10);
providing for, by rotation of the hinge, mating the third opening with the second opening to form a sealed enclosed space within the upper and lower portions (see ¶[0107]-[0108] and Figs. 8-10, the mating of the lid 215 and the body 220 via the openings to make the sealed enclosed space, sealed via the seal 210);
coupling a laparoscopic tube to the sheath at a proximal end of the laparoscopic tube (¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303] the embodiments disclosed herein may be combined, which would include the laparoscopic tube 15 of the laparoscopic oximeter 5 and sheath 205 on the probe unit 10, via the various connectors including electrical, the laparoscopic tube 15 is coupled to the probe unit 10 via the proximal end; Figs. 30-34); and
coupling sensor head to a distal end of the laparoscopic tube (¶[0301]-[0302] the laparoscopic tube 15 includes an elongated tube 315 with a sensor head 25 on the distal end; Figs. 30-34);
providing a second device portion (¶[0052]-[0054] the system unit 301, ¶[0301] the probe unit 10, ¶[0047] the probe may be the system unit; Figs. 1-3 and 30-34) comprising:
providing an enclosure for the second device portion (¶[0052] the housing 705 and the power block 351; Figs. 1-3);
providing an interior space inside the enclosure (¶[0052] the various computing and sensing components within the housing 705, while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3);
providing an electrical connector at a distal end of the enclosure (¶[0055]-[0057] the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 4 and 30);
providing a printed circuit board in the interior space of the enclosure and electrical circuitry coupled to the printed circuit board and the electrical connector (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Fig. 4);
providing a battery compartment, formed in the enclosure (¶[0088] the power block 351 may include a battery module including one or more batteries 356; Fig. 4);
covering the battery compartment with a battery cover that forms an exterior surface of the enclosure (see Figs. 1-3, the power block 351 forms part of the exterior surface alongside the housing 705); and
providing a display coupled to the enclosure and the printed circuit board (¶[0052] the display 307, ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB); Figs. 1-4),
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see Figs. 8-10, the system unit 301/the probe 20 is sealed within the sealed enclosed space of the sheath 205).
Margiott teaches the combination of the embodiments, including the usage of the sheath with the system/probe and laparoscopic tube (see generally ¶[0041]-[0047], ¶[0081], and ¶[0300]-[0303]), but does not teach the specifics of the connection of the laparoscopic tube to the probe and sheath portions.
OuYang teaches an endoscope with a reusable part sealed within a single use sheath (see abstract and Figs. 1-3),
providing a first device portion (¶[0026] the single use (i.e., the sheath) portion 108; Figs. 1-2) comprising:
providing an upper portion of a sheath of the first device portion (¶[0026] the cap 114; Figs. 1-3) and a lower portion of the sheath of the first device portion (¶[0026] the sheath 110; Figs. 1-3);
coupling the upper and lower portions of the sheath (¶[0026]-[0027] the proximal end 110a of the sheath mates with the opening of the lid 114 to form the enclosure; Figs. 1-3);
providing a first opening in the lower portion at a distal end of the lower portion (¶[0026] and ¶[0029] the distal end 110b with the matching contacts 600a-600c; Fig. 6) and a second opening in the lower portion at a proximal end of the lower portion (¶[0026] the proximal end 110a for the lid 114; Figs. 2-3);
providing a third opening in the upper portion at a distal end of the upper portion (¶[0026] the opening of the lid 114 about the reusable portion 112 for contacting the proximal end 110a opening; Figs. 2-3);
coupling a laparoscopic tube the first opening of the lower portion at a proximal end of the laparoscopic tube (¶[0026] and ¶[0029]-[0030] the reusable needle contacts (i.e., laparoscopic tube portion) are received in the connector 120a-120c of the reusable portion 112 facilitated by the matching contacts 600a-600c of the sheath 110; Figs. 2-4 and 6-7);
providing a second device portion (¶[0026] the reusable portion 112; Figs. 1-3);
wherein the enclosure of the second device portion fits into the upper portion of the sheath of the first device portion, and when the third opening mates with the second opening, the enclosure of the second device portion is within the sealed enclosed space within the upper and lower portions of the first device portion (see ¶[0026]-[0028] and Figs. 1-3, the reusable portion 112 is sealed within the sheath 110 and the cap 114).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the disposable connection (i.e., via the distal openings in the sheath) modality of OuYang with the sheath and laparoscopic tube of Margiott because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results (i.e., the laparoscopic tube connected via matching opening in the sheath to the probe); and/or (2) Margiott requires a connection of the laparoscopic tube to the probe through the sheath and OuYang teaches one such modality.
Regarding Claim 26, Margiott in view of OuYang teaches the method of claim 25 as stated above. The modified Margiott further teaches providing the lower portion comprises an electrical connector (see OuYang ¶[0026] and ¶[0029] the distal end 110b with the matching contacts 600a-600c; Fig. 6), and
when the enclosure is within the sealed enclosed space, the electrical connector of the enclosure couples to the electrical connector of the lower portion (see Margiott ¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB), the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors, Figs. 1-4 and 30; see OuYang ¶[0026] and ¶[0029]-[0030] the reusable needle contacts (i.e., laparoscopic tube portion) are received in the connector 120a-120c of the reusable portion 112 facilitated by the matching contacts 600a-600c of the sheath 110, Figs. 2-4 and 6-7).
Regarding Claim 27, Margiott in view of OuYang teaches the method of claim 26 as stated above. Margiott further teaches providing for data optical measurement information (¶[0302] the data from the sensor head 25 that emits light and collects reflected light is data optical measurement information) to transfer from the lower portion to the enclosure through the electrical connectors of the lower portion and the enclosure (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB), the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 1-4 and 30) in a digital format (¶[0278]-[0280] the real-time input may be a digital input from a digital circuit, such as via an analog-to-digital converter).
Regarding Claim 28, Margiott in view of OuYang teaches the method of claim 27 as stated above. Margiott further teaches providing for data optical measurement information (¶[0302] the data from the sensor head 25 that emits light and collects reflected light is data optical measurement information) to transfer from the lower portion to the enclosure through the electrical connectors of the lower portion and the enclosure (¶[0055]-[0058] the various electrical components may have direct connections to the processor 304 via the bus 303, in which the bus 303 may be implemented as a printed circuit board (PCB), the sensor probe 346 connected via the connector 336, ¶[0301] the connectors 20, including electrical connectors; Figs. 1-4 and 30) in a digital format an not an analog format (¶[0278]-[0280] the real-time input may be a digital input from a digital circuit, such as via an analog-to-digital converter).
Regarding Claim 29, Margiott in view of OuYang teaches the method of claim 25 as stated above. Margiott further teaches the electrical circuitry comprises a processor (¶[0055] the processor 304) and wireless communication circuit (¶[0049] the probe may be connected via a wireless communication circuit to another device, such as a smart phone or display).
Regarding Claim 30, Margiott in view of OuYang teaches the method of claim 29 as stated above. Margiott further teaches providing the processor determines an oxygen saturation value (¶[0075]-[0076] the device includes software for making oxygen saturation measurements to be executed by one or more processors 304, ¶[0048] the probe may be a standalone device for making such measurements; Fig. 4), and
the enclosure does not include light emitting diodes or laser diodes or photodetectors (¶[0052] while light sources and detectors are mentioned here, in the laparoscopic embodiment, the light sources and detectors would not be located in the housing 705, but in the sensor head 25 (see ¶[0302]); Figs. 1-3 and 30-34).
Regarding Claim 31, Margiott in view of OuYang teaches the method of claim 29 as stated above. Margiott further teaches displaying in a first screen of the display a numerical percentage of oxygen saturation value (¶[0112] the display 307 may show an oxygen saturation (StO2) percent value; Figs. 12-13).
Regarding Claim 32, Margiott in view of OuYang teaches the method of claim 29 as stated above. Margiott further teaches displaying in the first screen of the display a battery level indication (¶[0112] the display 307 may show an indicator 1920 for an amount of available battery power in the battery; Figs. 12-13).
Regarding Claim 33, Margiott in view of OuYang teaches the method of claim 29 as stated above. Margiott further teaches displaying in the first screen of the display a bar level indication of the oxygen saturation value (¶[0112] the display 307 may show a quality metric 1915 for the oximetry information 1900, including the oxygen saturation; Figs. 12-13).
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
