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
1. 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.
Claims1-5,10,15 and 16-17 rejected under 35 U.S.C. 101.
Regarding claims 1-5,10,15 and 16-17 under the broadest reasonable interpretation, the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skilled in the art. See MPEP 2111.
The claimed invention acquires images (radiographing such as CT or MRI) of an organ such as lung or heart of a person for gauging or calculating a tracheal diameter from the tracheal walls in the intrathoracic region.
The claims are directed mental process and do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
The claims do not have any limitations that are indicative of integration of the judicial exception into a practical application such as improvements to functioning of a computer or a technical field, using any particular machine, effect a transformation of a particular article to a different state or thing, or apply the judicial exception in any meaningful way beyond generally linking the use to a particular technological environment. Therefore, the claims as a whole do not amount to significantly more than the judicial exception.
A patent may be obtained for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof," 35 U.S.C. § 101, but "laws of nature, natural phenomena, and abstract ideas are not patentable."
Step 1
Claims1-5,10,15 and 16-17 are directed to one of the four statutory categories of eligible subject matter (process): thus, the claim pass Step 1 of the Subject Matter Eligibility Test.
Step 2A, prong 1 analysis
Claims1-5,10,15 and 16-17 directs to a judicial exception in terms of mental processes which can be performed by human being with aids of simple tools like pen, ruler and paper. A radiologist can manually retrieve and compare current images of tracheal diameter of chest with the past chest images of tracheal diameter for corresponding diagnosis; takes measurements using a ruler; infers complications from known feature patterns or look-up table; visually accesses disease/condition progression based on the measurement and comparison; and composes a diagnostic report.
Step 2A, prong 2 analysis
The claims do not have any limitations that are indicative of integration of the judicial exception into a practical application such as improvements to functioning of a computer or a technical field, using any particular machine, effect a transformation of a particular article to a different state or thing, or apply the judicial exception in any meaningful way beyond generally linking the use to a particular technological environment.
Step 2B
Further, the claims do not include other additional elements that are beyond what is well-understood, routine, conventional activities in the field and sufficient to amount to significantly more than the judicial exception.
Conclusion
The claims do not include additional elements amount to significantly more in terms of improving functionalities of a computer/device itself, improving another technology or technical field, effecting a transformation or reduction of a particular article to a different state or thing, adding unconventional steps that confine claim to a particular useful application or by use of a particular machine that is unconventional. In conclusion, the claims 1-15 and 17 do not comply with the current standards for patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 103
2. 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.
Claims 1,4-5 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nemes et al. US 20180289515 (hereinafter Nemes) in view of Turek et al. US 20050105788 (hereinafter Turek).
Regarding claim 1, Nemes provides for receives a dynamic image that includes a plurality of frame images taken by dynamically radiographing an expiratory state of a subject including a trachea ( see [0062], see “The airway of a patient suffering from TBM can be measured using dynamic or “breathing” computed tomography (CT) scan, sometime also referred to as a 4DCT scan”) ; sets an inside of a chest cavity in each of the plurality of frame images, as an intrathoracic region; extracts tracheal walls from the plurality of frame images; and gauges a tracheal diameter from the tracheal walls in the intrathoracic region ( see [0062], see “Airway measurement 502 can provide an indication of the range of diameter of the airway, including a minimum and maximum diameter of the airway”). Nemes does not specifically provide for extracting the tracheal walls . Turek teaches the above missing limitation of Nemes (See [0037], see “ In measuring the airway wall cross-sectional area, it is necessary to isolate the airways from the attaching or adjacent blood vessels so that the thickness measurement does not incorporate such vessels”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Turek with the system and method of Nemes, in order to obtain the claimed invention, via measuring airway cross-sectional area from medical images (for instance CT) will enable physicians to track disease progression and accelerate clinical trials, a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable ( MPEP 2143).
Regarding claim 4, Nemes provides for, wherein the hardware processor sets a bronchial region, and the hardware processor gauges the tracheal diameter in a range except the bronchial region ( see [0062], see “Airway measurement 502 can provide an indication of the range of diameter of the airway, including a minimum and maximum diameter of the airway”, airway such as a trachea or bronchus).
Regarding claim 5, Nemes provides for, wherein the hardware processor causes a display to display a gauging result ( see [0062], see “the airway can be measured using magnetic resonance imaging (MRI). Airway measurement 502 can provide an indication of the range of diameter of the airway, including a minimum and maximum diameter of the airway”). Examiner interpret that the MRI images show range of minimum and maximum diameter of the airway, which corresponds to display.
Regarding claim 15, see the rejection of claim 1. It recites similar limitations as claims 15. Except for the image analysis apparatus( see [0062] of Nemes, see “ the airway can be measured using magnetic resonance imaging (MRI)”. Hence it is similarly analyzed and rejected.
Regarding claim 16, see the rejection of claim 1. It recites similar limitations as claims 16. Hence it is similarly analyzed and rejected.
Regarding claim 17, see the rejection of claim 1. It recites similar limitations as claims 1. Except for a computer readable recording medium storing a program (see [0018] of Turek see “The network includes analysis software executable on a computer, wherein the software includes instructions configured to instruct the computer to detect, quantify, stage, report, and/or track a disease utilizing images of a patient”).Hence it is similarly analyzed and rejected.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Nemes et al. US 20180289515 (hereinafter Nemes) in view of Turek et al. US 20050105788 (hereinafter Turek), further in view of Udupa et al. US 20250029260 (hereinafter Udupa).
Regarding claim 2 Nemes as modified by Turek does not provide for, wherein the hardware processor sets the intrathoracic region, based on a structural object of a thorax. Udupa teaches the above missing limitations of Nemes as modified by Turek ( see [0139] of Udupa, see “ Row 4 demonstrates: left: Sagittal contrast-enhanced computed tomography (CT) simulation image through the thorax shows degenerative change and exaggerated kyphosis of the thoracic spine with associated distortion of the thoracic spinal canal and other intrathoracic structures”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Udupa with the system and method of Nemes as modified by Turek, in order to obtain the claimed invention, via providing the intrathoracic region, based on a structural object of a thorax.
Regarding claim 3 Nemes as modified by Turek does not provide for, wherein the structural object of the thorax is at least one of a sternoclavicular joint, a vertebral body, and a thoracic rib. Udupa teaches the above missing limitations of Nemes as modified by Turek ( see [0139] of Udupa, see [0060] of Udupa, see “ identification method for vertebra on CT scans. This method segments one vertebra in each iteration and uses the previously segmented vertebrae to guide anatomy as anatomy for the next iteration”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to combine the teaching of Udupa with the system and method of Nemes as modified by Turek, in order to obtain the claimed invention, via providing for identification method for vertebra on CT scans.
Allowable Subject Matter
3. The following is a statement of reasons for the indication of allowable subject matter: Claims 6-9 and 11-14 would be in allowable condition, if applicant overcome the 35 USC § 101 rejection above.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: the prior arts of over Nemes et al. US 20180289515 in view of Turek et al. US 20050105788 , further in view of Udupa et al. US 20250029260, failed to teach or suggest for features/limitations of claims 6-9 and 11-14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kaczka et al. US 20150290418, is cited because the reference teaches “[0054] The resolution of severe bronchoconstriction in response to inhalational anesthetics agent in terms of oscillatory impedance, CT measurement of airways lengths and diameters, as well as CT registration of regional tissue mechanics are monitored”.
Hwang et al. US 20220202274, is cited because the reference teaches “The overlay 820 representing a diameter of the airway structure 800 may be, for example, a best-fit circle provided on the calculated airway diameter for a given focal plane. The aspect shown in FIG. 6 may similarly be displayed on the operation console 600 during the procedure”, in [0048].
Qiu US 10368800 is cited because the reference teaches “As a further example, the device may be positioned within the nasal cavity during the awake state to record baseline measurements of airway diameter and other physiological parameters”, in col.3 Lines 63-66.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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/ALI BAYAT/ Primary Examiner, Art Unit 2677