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
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 recites the steps receiving a plurality of proximity signals, processing the plurality of proximity signals to determine a characteristic and determine an indication of one or more nasal pathologies based on the determined characteristic.
The limitation of processing the proximity signals and determining a nasal pathology, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, “processing” and “determining” in the context of this claim encompasses the user manually calculating a characteristic or trend and making a mental determination. 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 the additional elements proximity sensors and a nasal probe. These sensors involve mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and implied output device are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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 3, 6, 8, 9, 11 and 13 and all claims that depend from them 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. The claims recite limitations that are preceded by “preferably” this makes it unclear if those limitations are actually needed as it is assumed this are possible extra features or functions that are not actually needed.
Claim 7 is 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. It is not clear if the one or more proximity sensors that are recited as part of the nasal probe are the same as the proximity sensors recited in claim 1 or are then different sensors.
The term “substantially equal” in claim 11 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-4, 7, 14-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. 2019/0192045 (see IDS 1/6/23).
Regarding claims 1, 15 and 16, Fang discloses a system for assessing nasal pathologies of a subject, the system comprising ([FIG1] system 100): a processor ([¶15] processor 14) configured to:
receive a plurality of proximity signals representative of a respective plurality of detected distances of an inner surface of a nostril of the subject from one or more proximity sensors ([¶18,23] sensor monitor the distance to the internal structure);
process the plurality of proximity signals to determine one or more characteristics of the plurality of detected distances ([¶13,29-30] the signals are used in creating a digital anatomical model); and
determine an indication of one or more nasal pathologies based on the determined one or more characteristics of the detected distances ([¶13,29-30] the system can indicate structures to be monitored based on the distance data. The claim does not specify that the distance data itself determines the pathologies).
Regarding claim 2, Fang discloses the system can indicate the one or more nasal pathologies comprise at least one of: deviated nasal septum; perforation in the nasal septum; nasal polyp; hard crust; turbinal hypertrophy; and nosebleed ([¶29]).
Regarding claim 3, Fang discloses the processor is further configured to:
determine at least one property of the one or more nasal pathologies based on the determined one or more characteristics of the detected distances, and preferably wherein the at least one property comprises one more of: a size; a shape; a location; a depth; and a measure of severity ([¶29] the system shows size, shape, location and distance from the sensor).
Regarding claims 4 and 20, Fang discloses the plurality of proximity signals are representative of a respective plurality of detected distances with respect to the same nostril of the subject,
and wherein one or more characteristics of the plurality of detected distances comprise one or more of:
variation in distance values;
deviation from an expected distance value;
comparison against a maximum threshold value; and
comparison against a minimum threshold value ([¶67] thresholds for the distance are used).
Regarding claim 7, Fang discloses a nasal probe comprising one or more proximity sensors adapted to be inserted into a single nostril of the subject, wherein each of the one or more proximity sensors is adapted to detect, when inserted into the nostril of the subject, a respective distance of an inner surface of the nostril to the proximity sensor, and to generate a respective proximity signal representative of the detected distance ([¶18,23] sensor monitor the distance to the internal structure).
Regarding claim 14, Fang discloses the processor is further configured to: determine a guidance indication based on the determined one or more characteristics of the detected distances ([¶25] the visual display shows the markers for location).
Regarding claim 17, Fang discloses the device further comprising at least one supplementary sensor configured to measure a secondary characteristic of the nostril of the subject, wherein the output is further configure to transmit the supplementary sensor measurements to the processor, and wherein the processor is configured to process the received supplementary sensor measurement to determine a supplementary characteristic of the subject ([¶21] a camera is also used).
Regarding claim 18, Fang discloses the supplementary sensor is at least one of: a thermometer, an accelerometer, an air flow sensor, a gyroscope, and/or a camera ([¶21] a camera is also used).
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 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Shemen et al. “Preoperative and postoperative nasal septal surgery assessment with acoustic rhinometry” (see IDS 1/6/23).
Regarding claims 5 and 8, Fang discloses using the distance measures to map the nasal cavity but does not specifically disclose the processor is configured to determine an indication of deviated nasal septum based on the determined variation in distance values and/or the determined deviation from an expected distance value. Shemen teaches a similar nasal system, specifically acoustic rhinometry, that uses the distance measures to determine deviation of the septum ([pg. 340]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Fang with the teachings of Shemen in order to assess the treatment of the treatment ([pg. 340]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Shemen et al. further in view of Gertner et al. 2007/0219600 (see IDS 1/6/23).
Regarding claim 10, Fang does not specifically disclose the device has first and second arms. Gertner however teaches a similar nasal monitoring and inspection device that comprises a nasal probe with first and second arms adapted to be simultaneously inserted into the first and second nostrils of the subject ([FIG10,11][¶134,135]), respectively, wherein each of the first and second arms comprises at least one of the one or more proximity sensors, each proximity sensor being adapted to detect, when inserted into a nostril of the subject, a respective distance of an inner surface of the nostril to the proximity sensor, and to generate a respective proximity signal representative of the detected distance ([¶124,134,135] distance sensors are used to determine positioning). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Fang with the dual arms of Gertner in order to treat both nasal cavities simultaneously ([¶135]).
Claim(s) 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fang in in view of Jackson et al. 5316002 (see IDS 1/6/23).
Regarding claim 13, Fang discloses the device can determine indications of polyps based on the distances but does not disclose wherein the processor is configured to: identify respiratory cycles of the subject. Jackson however teaches a similar nasal device that determines are flow and thus respiration ([C6 L55-65]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Fang with the temperature sensor of Jackson in order to non-invasively determine septum length.
Regarding claim 19, Fang does not disclose the supplementary characteristic of the subject is at least one of: a respiration characteristic and/or a temperature characteristic. Jackson teaches a similar nasal device that determines temperature as characteristic of the respiration cycles ([C6 L55-65]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Fang with the temperature sensor of Jackson in order to non-invasively determine septum length.
Allowable Subject Matter
Claims 6, 9, 11 and 12 do not have art applied.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record does not disclose determining a perforation of the nasal septum based on the detected distance.
Conclusion
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791