DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) receive the oxygenation signal from the blood oxygen sensor; and compare the oxygenation signal from the blood oxygenation sensor with known human performance data. These limitations, as drafted, are processes that, under their broadest reasonable interpretations, cover performances of these limitations in the mind but for the recitation of generic computer components. That is, other than reciting “outer shell”, “seal”, “physiological sensor”, and “processor”, nothing in the claim element precludes the limitations from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements- reciting “outer shell”, “seal”, “physiological sensor”, and “processor” are recited at high-level of generality (i.e., as generic physiological sensor, a generic processor performing a generic computer function of processing information and determining data based on the processed information); these elements amount no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim(s) is directed to an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using physiological sensor to measure a physiological parameter of the user and an environmental sensor detecting an environmental parameter, and using a processor to process the physiological parameter and environmental parameter and identify the relationship between them and determine an alarm condition with known human performance data amount to no more than mere instructions to apply the exception using a generic sensor and a generic computer component. Mere instructions to apply an exception using a generic biosensor and a generic computer component cannot provide an inventive concept. The claim(s) is not patent eligible.
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.
Claim(s) 1-3, 7 and 11-14, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson (USPN 5,372,134).
Regarding claims 1, 7 and 11, 17, Richardson discloses a system for measuring oxygenation signals, comprising: a commercial aviation headset (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30) comprising an outer shell (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); a seal coupled to the outer shell (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); a blood oxygen sensor configured to: be in contact with a user (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); be located behind an ear of the user (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); and measure an oxygenation signal of the user (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); a processor configured to: receive the oxygenation signal from the blood oxygen sensor (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); and compare the oxygenation signal from the blood oxygenation sensor with the environmental parameter (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30), determine a physiological alarm condition as a function of the relationship (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30). Richardson discloses an interface configured to communicate between the processor and the commercial aviation headset electronics (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30).
Regarding claims 2 and 12, Richardson discloses the blood oxygen sensor is located proximal the user’s sternocleidomastoid muscle (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30).
Regarding claims 3, 13, Richardson discloses a transducer configured to send an alarm signal to the user; and wherein the processor is further configured to generate the alarm signal as a function of the comparison between the oxygenation signal and the known human performance data (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30); Richardson discloses the interface is further configured to send an alarm signal to the commercial headset to be communicated to the user; and the processor is further configured to generate the alarm signal as a function of the comparison between the oxygenation signal and the known human performance data (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30).
Regarding claims 4 and 14, Richardson discloses that the alarm signal is an audible signal (figures 1-2, Col.2 lines 10-47, Col.4 lines 1-30).
claims 5, 15,
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.
Claim(s) 5-6,8-10,15-16,18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson as applied to claims 1, 7 and 11, 17 above, and further in view of Buza (USPN 10,595,758).
Richardson fails to disclose subject matter of claims 5-6,8-10,15-16,18-20. Buza discloses a device for training pilots using physiological sensor feedback for flight circumstances that cause hypoxemia (see Abstract: system for detecting onset of hypoxia; the device can be used for training pilots in a pressurized simulator see col.3, 11.47- 61, col. 16, II.36-46), the device (Figs. 1-3: apparatus 10) comprising: a housing (headset 12) configured to be mounted to an exterior body surface of a user (headset 12 is worn over the head/ears of the pilot, as shown in Fig. 1A and col.5, II.10-22);
at least a physiological sensor (pulse oximeter 18) attached to the housing (see Figs. 1A, oximeter 18 is attached to earpieces 30a/30b of headset 12) and configured to detect at least a physiological parameter associated with hypoxemia (col.5, U.27-34 oximeter 18 measures oxygen saturation and heart rate); and a training and feedback processor (processor 40) in communication with the at least a physiological sensor (col.6, II.28-62 and Fig. 2: oximeter 18 is coupled with processor 40), the training and feedback processor designed and configured to: detect at least a flight condition having a causative association with hypoxemia (col.6, .39-44 processor 40 receives altitude, and/or cabin pressure data from altimeter or pressure sensor 19. See col.3, II.47-61 for discussion of cabin pressure causing hypoxia; also see Fig. 4B:161); measure, using the at least a physiological sensor (oximeter 18), at least a physiological parameter associated with hypoxemia (col.5, II.32-33 & II.58-62 oximeter 18 measures oxygen saturation and heart rate, both indicative of hypoxia; also see Fig. 4A:102, 106, Fig.4B: 151, 155); and determine, by the training and feedback processor, and based on the at least a physiological parameter, a degree of pilot hypoxemia (col.8, U.56- col. 10, 11.45 using processed data from oximeter 18 and pressure sensor 19 to determine an onset of hypoxia using a (hypoxia) slope index. Also see Fig.4B:157 and 159. The system defines 'mild' or 'severe' hypoxia in col. 4, II.22-54. Fig. 5: "hypoxia slope index" or "slope index" is interpreted as "degree of hypoxemia" in the claim, see col. 14, ll.33-col.15, II.48, the hypoxia slope index is calculated using a ratio of oxygen saturation and ratio of heart rate, and the magnitude of the slope index is indicative of a degree or state of hypoxic event); and a user signaling device (onboard alarm systems, e.g. control station display 35, buzzer 46) in communication with the training and feedback processor, the user signaling device configured to indicate the degree of pilot hypoxemia to at least a user (col.6, IL.66- col.7, 11.5, col.9, II.39-49 based on the determination of onset or degree of hypoxia from the slope index calculation, the control station 35/buzzer 46 triggers one or more alerts to notify one or more users/pilots, see Fig.4A:114, Fig. 4B:165. Also see col.15, II.41-63 when the hypoxia slope index in within a threshold range, an alarm is triggered). Buza discloses the device of claim 1, wherein the at least a physiological sensor further comprises a heart- rate sensor (pulse oximeter 18 measures heart rate, thus is it interpreted as comprising a "heart rate sensor "; see col.5, II.27-34 and col.6, 11.3- 7). measuring includes measuring at least a hematological parameter (heart rate and oxygen content in the blood -which are hematological parameters according to the Applicant's Specification [0013-0014]); and determining further comprises determining the at least a hematological parameter is associated with the level of hypoxemia (col. 7, II.62-col.8, 11.32 discusses using oxygen level thresholds to determine the onset of hypoxia or hypoxia symptoms; also see col. 14, II.33-col. 15, 11.48, the hypoxia slope index, previously interpreted as "the degree of hypoxemia" in the claim, is calculated based on ratio of oxygen saturation and ratio of heart rate, and the magnitude of the slope index is indicative of the level of hypoxia event). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made before the effective filing date of the claimed invention to incorporate the device of Buza into the device of Richardson, in order to obtain more accurate measurements.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,667,731. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,667,731. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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