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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
This analysis is based on the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (2024 AI SME Update) published on July 17, 2024 (89 FR 58128).
With regard to claims 1-20:
Step 1:
Claims 1-20 are directed to a method and computing device which fall under the statutory categories of invention of machines. Therefore, step 1 is met.
Step 2A, Prong 1:
Claim 1 recites a method for “obtaining predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model” and “classifying a region…based on the predicted pneumothorax information and predicted tube information.” The limitations fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. Under its broadest reasonable interpretation when read in light of the specification, the use of one or more neural networks encompasses mental processes practically performed in the human mind. See MPEP 2106.04(a)(2), subsection III.
Claim 11 recites “at least one processor” to “obtain predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model” and “classify a region…based on the predicted pneumothorax information and predicted tube information.” The limitations, excluding the processor, therefore fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. Under its broadest reasonable interpretation when read in light of the specification, the use of one or more neural networks encompasses mental processes practically performed in the human mind. See MPEP 2106.04(a)(2), subsection III.
Dependent claims 2, 3, 5-7, 12, 13 and 15-17 add limitations that further use the trained model, which are also considered to be mental processes.
Dependent claims 4, 8-10, 14 and 18-20 add limitations in the manner of displaying without adding limitations on the obtaining and classifying functions of claims 1 and 11. Therefore, they do not resolve the issues of the claims being abstract.
Step 2A, Prong 2:
The limitations of claim 1 are recited without mention of a specific hardware or machine to implement said method.
The limitations of claim 11 are recited as being performed by “at least one processor”. The processor is recited at a high level of generality. The processor is used to perform an abstract idea, as discussed above in Step 2A, Prong One, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f), which provides the following considerations for determining whether a claim simply recites a judicial exception with the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer: (1) whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished; (2) whether the claim invokes computers or other machinery merely as a tool to perform an existing process; and (3) the particularity or generality of the application of the judicial exception.
In evaluation of whether the invention integrates into a practical application, it should be clear that the claimed invention improves the functioning of a computer or improves another technology or technical field. To evaluate an improvement to a computer or technical field, the specification must set forth an improvement in technology and the claim itself must reflect the disclosed improvement. See MPEP 2106.04(d)(1) and 2106.05(a).
According to the specification, the ability to identify pneumothorax independently of the patient’s posture is accomplished by identifying a patient’s left and right region relative to the spine. None of these elements are explicitly recited in the claims. Claim 6 recites the image into two regions but it does not make it clear that these are the left and right regions. Claim 7 recites that the training images are tagged with left and right labels but it does not make clear these are applied to classifying the image in conjunction with spinal information.
Step 2B:
Claims 1-20 do not contain additional elements for consideration outside of the previously stated abstract elements as outlined in Prong One above.
In claims 1 and 11, the limitations of receiving the medical image amounts to merely receiving data. Claims 4, 8-10, 14 and 18-20 discuss the manner of displaying, which amounts to merely outputting data. These limitations are considered to be extra-solution activity. In consideration, these limitations are further evaluated to take into account whether or not the extra-solution activity is well understood, routine, and conventional in the field. See MPEP 2106.05(g). Receiving and presenting data is very well understood and routine in the field and therefore these do not add an inventive concept to the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,564,650. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘650 anticipate the instant claims.
Regarding claim 1, ‘650 discloses an emergency patient classification method performed by a computing device, comprising:
receiving a medical image of a patient (col. 14, line 30; col. 15, line 22);
obtaining predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model (col. 14, lines 28-31; col. 15, lines 27-38); and
classifying a region in the medical image as one of an emergency pneumothorax, a general pneumothorax, normal, or other lesions without the pneumothorax, based on the predicted pneumothorax information and the predicted tube information (col. 14, lines 46-49; col. 14, lines 57-60; col. 15, lines 42-46).
Regarding claim 11, ‘650 discloses a computing device comprising:
a memory (col. 16, line 44); and
at least one processor for executing instructions stored in the at least one memory (col. 16, lines 45-47), wherein the at least one processor is configured to:
receive a medical image of a patient (col. 16, lines 48-49; col. 15, line 22);
obtain predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model (col. 16, lines 50-53; col. 15, lines 27-38); and
classify a region in the medical image as one of an emergency pneumothorax, a general pneumothorax, normal, or other lesions without the pneumothorax, based on the predicted pneumothorax information and the predicted tube information (col. 16, lines 58-61; col. 17, lines 13-16; col. 15, lines 42-46).
Claims 9, 10, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,564,650 in view of Frid-Adar et al. (“Endotracheal Tube Detection and Segmentation in Chest Radiographs using Synthetic Data”)
Regarding claims 9 and 19, ‘650 discloses the elements of claim 8 and 18 as described above.
‘650 does not explicitly disclose displaying the predicted pneumothorax information and/or the predicted tube information as a heat map.
Frid-Adar et al. teaches a method in the same field of endeavor of chest radiograph detection, comprising:
displaying the predicted pneumothorax information and/or the predicted tube information as a heat map (“Figure 7 shows a heatmap visualization of the last convolutional layer of the network. This visualization clearly indicates the localization on the ET tube area.” At section 3.3, paragraph 2, last sentence).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the heatmap display as taught by Frid-Adar et al. in the system of ‘650 to clearly indicate the location of the chest tube in the radiograph to aid the user in determination of criticality.
Regarding claims 10 and 20, discloses the elements of claim 8 and 18 as described above.
‘650 does not explicitly disclose displaying the predicted pneumothorax information and/or the predicted tube information as a contour connecting points at which prediction value is greater than or equal to a threshold value.
Frid-Adar et al. teaches a method in the same field of endeavor of chest radiograph detection, comprising:
displaying the predicted pneumothorax information and/or the predicted tube information as a contour connecting points at which prediction value is greater than or equal to a threshold value (“Cases correctly classified with ET tube and their corresponding seg-mentation as overlay.” At Figure 6 description; “Figure 6 shows real chest radiographs from the test set that were classified correctly for presence of ET tube and their output segmentation maps.” At section 3.3., first paragraph, last sentence).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the heatmap display as taught by Frid-Adar et al. in the system of ‘650 to clearly indicate the location of the chest tube in the radiograph to aid the user in determination of criticality.
The following is a mapping of the instant claims to the claims of ‘650:
Claims of Instant Application
Claims of ’650
1
1+2 or 1+4 or 7 or 13+15
2
4
3
2
4
3 or 5
5
1
6
1
7
6
8
5
9
1+2 + Frid-Adar et al. or 1+4 + Frid-Adar et al. or 7 + Frid-Adar et al. or 13+15 + Frid-Adar et al.
10
1+2 + Frid-Adar et al. or 1+4 + Frid-Adar et al. or 7 + Frid-Adar et al. or 13+15 + Frid-Adar et al.
11
1+2 or 1+4 or 7 or 13+15
12
4
13
2
14
3 or 5
15
1
16
1
17
6
18
5
19
1+2 + Frid-Adar et al. or 1+4 + Frid-Adar et al. or 7 + Frid-Adar et al. or 13+15 + Frid-Adar et al.
20
1+2 + Frid-Adar et al. or 1+4 + Frid-Adar et al. or 7 + Frid-Adar et al. or 13+15 + Frid-Adar et al.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. US 11,996,184. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘184 anticipated the instant claims.
Regarding claim 1, ‘184 discloses an emergency patient classification method performed by a computing device, comprising:
receiving a medical image of a patient (col. 14, line 29);
obtaining predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model (col. 14, lines 30-32); and
classifying a region in the medical image as one of an emergency pneumothorax, a general pneumothorax, normal, or other lesions without the pneumothorax, based on the predicted pneumothorax information and the predicted tube information (col. 14, lines 33-37).
Regarding claim 11, ‘184 discloses a computing device comprising:
a memory (col. 15, line 8); and
at least one processor for executing instructions stored in the at least one memory (col. 15, lines 9-10), wherein the at least one processor is configured to:
receive a medical image of a patient (col. 15, line 12);
obtain predicted pneumothorax information and predicted tube information from the medical image based on a trained pneumothorax prediction model (col. 15, lines 13-15); and
classify a region in the medical image as one of an emergency pneumothorax, a general pneumothorax, normal, or other lesions without the pneumothorax, based on the predicted pneumothorax information and the predicted tube information (col. 15, lines 16-20).
The following is a mapping of the instant claims to the claims of ‘184:
Claims of Instant Application
Claims of ’184
1
1 or 9
2
2 or 10
3
1 or 9
4
7 or 8 or 15 or 16
5
4
6
5
7
6
8
7 or 8 or 15 or 16
9
7 or 15
10
8 or 16
11
1 or 9
12
2 or 10
13
1 or 9
14
7 or 8 or 15 or 16
15
4
16
5
17
6
18
7 or 8 or 15 or 16
19
7 or 15
20
8 or 16
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA R FUJITA whose telephone number is (571)270-1574. The examiner can normally be reached Monday - Friday 9:30-5:30 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached at 5712723638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRINA R FUJITA/ Primary Examiner, Art Unit 2672