Part III DETAILED ACTION
1.The present application is being examined under the pre-AIA first to invent provisions. This application has been examined. Claims 1-14 are pending in this application.
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.
2. Claim(s) 1-14 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion, organizing human activity and/or mathematical concepts and calculations). The independent claim(s) recite(s) a method for characterizing lung disease features in terms of mass … within a region of interest. Having the steps of acquiring of data, defining a region, assigning a texture type, and calculating a total mass (which describe observation, receiving data and evaluating (calculating) , the combination of scenes or images can be done in a piece of paper and using reference points or markers to identify a point in the image or scene). This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved .The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claimed invention can be done mentally and no additional features in the claims would preclude them from being performed as such except for the generic computer elements at high level of generality (i.e., processor, memory).
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claims do not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that independent claim 1 is directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? YES. Independent claim(s) 1 is a method, and claim 25 is a computer program per se.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? YES , the claims are directed toward a mental process (i.e. abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations; certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion). The method(s) in claims 1,7 and 14 recites a mental process that can be practicably performed in the human mind, acquiring data, defining a region, assign a texture type, and calculating (or analyzing) a mass and total mass (Could be done by mental steps, a piece of paper or generic computers or components configured to perform the steps, the calculating step(s) can else represent a mathematical concept that can be performed by mental step, a piece of paper or generic computer); and, therefore, an abstract idea.
Regarding Claim(s) 1,7 and/or 14 recites a method(s) acquiring volumetric imaging data comprising a plurality of voxels (receiving a picture or image, same as a mental process including receiving data from a field of view of an image or picture similar to recognizing an area in an image) and having a reference area(s) on an image; defining a region of interest within the volumetric imaging data (equal to a mental process including observing and/or evaluating a region in mage(s) or scene(s), that can be perform mentally in the human mind or in a piece of paper) assigning a texture type to each voxel within the region of interest, the texture type for a given voxel selected from a predetermined list of texture types (equal to a mental process including observing and/or evaluating by labelling an image(s) or scene(s), and selecting from a list can be done mentally in the human mind or in a piece of paper); calculating a mass for each voxel based on its Hounsfield Units attenuation coefficients (equal to a mental process including observing and/or computing by adding portion or section of an image(s) or scene(s), that can be done mentally in the human mind or in a piece of paper); and calculating a total mass of a first texture type within the region of interest by summing the total mass of all voxels of the first texture type within the region of interest (equal to a mental process including observing and/or computing by adding multiple portion(s) or section(s) of an image(s) or scene(s), that can be done mentally in the human mind or in a piece of paper) ; Claim 14 further recites determining a percentage contribution by mass for at least one of the texture types within the region of interest by dividing the mass of the at least one texture type by the total mass of all voxels comprising the region of interest (equal to a mental process including observing and/or computing by adding operations and performing mathematical operation(s), that can be done mentally in the human mind or in a piece of paper) .
Claims 1,7 and 14 do not recite a practical application or improvement to the characterizing lung disease. The use of different operations and/or steps such as acquiring, defining and calculating represent a mental process.
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same). As such, a person could mentally analyze an image (or image of a lung) and determine or analyze the received data , either mentally or using a pen and/or paper. The mere nominal recitation that the various steps are being executed by a device/in a device (e.g. hardware processor), do not take the limitations out of the mental process grouping. Thus, the claim(s) 1 and 25 recite a mental process without reciting significantly more or an improvement.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the feature(s) of acquiring, defining and calculating using a well known method(s) (such as calculating mass using Hounsfield units attenuation coefficient (or steps) for characterizing lung disease, do not amount to significantly more. Claim(s) 2-6, 8-13 do not recite additional elements that integrate the judicial exception into a practical application or add additional elements that equal to significantly more. Steps of claims 2-6,8-13 represent well known mathematical functions that can be perform mentally or in a piece of paper.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claim(s) 2-6 and 8-13 does/do not recite any additional elements that are not well-understood, routine or conventional. The use of a computer to perform “receiving, evaluating, analyzing, calculating, computing, storing, comparing and/or displaying of data, are well-understood and conventional process that is performed by generic computers.
Thus, since independent claim(s) 1-14 is/are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that Claim(s) 1-14 is/are not eligible subject matter under 35 U.S.C 101.
Claims 2-6 and 8-13, do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): the features of claims 2-6 and 8-13 recite insignificant pre-solution extra activity of generating, manipulation of data ; Accordingly, the additional element(s) does/do not integrate the abstract idea into a practical application because the limitation(s) does/do not impose any meaningful limits on practicing the abstract idea.
Claim Rejections - 35 USC § 102
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 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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(2) as being by Min et al. (12,499,539) , hereafter referred as Min..
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
With regard to claim 1, Min teaches a method of characterizing lung disease (see col. 33, lines 39-67, col. 37, lines 30-57, clearly disease tracking of ‘539 can be used for lung disease detection) features in terms of mass for each of a given texture type (equal to the color, contrast or shade assigned) within a region of interest (reads on figs. 5a thru 6n, which depicts different shade(s) or color(s) to identify different portions of the image, see also col.62, lines 12-15), the method comprising: acquiring volumetric imaging data comprising a plurality of voxels (reads on figs. 5a thru 6n and col.7, lines 22-64, image(s) are obtained, the volume(s) are depicting of different voxel(s) of the image(s)); defining a region of interest within the volumetric imaging data (reads on figs. 6a-6n, which depicts how different areas can be selected (or defined); assigning a texture type to each voxel within the region of interest, the texture type for a given voxel selected from a predetermined list of texture types (reads on figs. 6j and 6k, and col. 69 thru col. 70, line 62, clearly different color can be selected by the editing tool); calculating a mass for each voxel based on its Hounsfield Units attenuation coefficients (see col. 24, lines 15-55, col. 29, lines 28-60 and col. 30, lines 15-48, col. 33, lines 39-67, col. 36, lines 10-21 and/or col. 163, line 45 thru col. 164, line 19, the mass (or volume) size and shape is detected), and calculating a total mass of a first texture type within the region of interest by summing the total mass of all voxels of the first texture type within the region of interest (reads on col. 33, lines 19-37, col. 51, lines 37-55, col.209, lines 1-31 and col.12, lines 35-53, different regions volume or mass are totaled).
With regard to claim 2, Min further teaches monitoring the total mass of the first texture type within the region of interest over time (reads on figs. 6a-6n and col. 98, lines 7-20, the user can monitor and/or view the different regions by a visual presentation) .
With regard to claim 3, Min further teaches calculating a total mass of all voxels within the region of interest by summing the mass of all voxels within the region of interest (reads on col. 33, lines 19-37, col. 51, lines 37-55, col.209, lines 1-31 and col.12, lines 35-53, different regions volume or mass are calculated and total); and determining a percent contribution by mass of the first texture type within the region of interest (reads on col. 41, lines 6-15, col. 49, lines 49-67, col. 24, lines 15-55, col. 29, lines 28-60 and col. 30, lines 15-48, col. 33, lines 39-67, col. 36, lines 10-21 and/or col. 163, line 45 thru col. 164, line 19, the mass (or volume) size and shape is detected for each region of interest or being processed) .
With regard to claim 4, Min further teaches for each texture type of the predetermined list of texture types, calculating a total mass of each texture type within the region of interest by summing the mass of all voxels corresponding to each respective texture type within the region of interest(reads on figs. 6j and 6k, and col. 69 thru col. 70, line 62, clearly different color can be selected by the editing tool ; and determining a percent contribution by mass for each texture type within the region of interest (reads on col. 41, lines 6-15, col. 49, lines 49-67, col. 24, lines 15-55, col. 29, lines 28-60 and col. 30, lines 15-48, col. 33, lines 39-67, col. 36, lines 10-21 and/or col. 163, line 45 thru col. 164, line 19, the mass (or volume) size and shape is detected for each region of interest or being processed). .
With regard to claim 5, Min further teaches determining a composite score (see fig. 3c step 366) to characterize lung disease, the composite score comprising an algebraic sum of the percent contributions by mass of two or more texture types within the region of interest (reads on col. 41, lines 6-15, col. 49, lines 49-67, col. 24, lines 15-55, col. 29, lines 28-60 and col. 30, lines 15-48, col. 33, lines 39-67, col. 36, lines 10-21 and/or col. 163, line 45 thru col. 164, line 19, the mass (or volume) size and shape are added for each region of interest or being processed).
With regard to claim 6, Min further teaches wherein the predetermined list of texture types includes two or more of the following texture types: ground glass, reticulation, emphysema, air trapping on RV scans, honeycombing, consolidation, and normal lung tissue (reads on col. 232, lines 50-67 for normal type, and col. 199, lines 54-65, clearly the different types of detected can be normal or emphysema assigned to a color, shade or contrast, see figs. 6j and 6k, and col. 69 thru col. 70, line 62, which clearly different color can be selected by the editing tool).
With regard to claims 7-14, the limitations of claims 7-14 are covered by the limitations of apparatus claims 1-6 above. Clearly the functions and steps of claims 1-6 are covered the limitations of claims 1-6 above. Clearly the “assigning a classification type of each voxel” of claim 7 is equal to the “assigning a texture type to each voxel” of claim1. The features of claim 14 are covered by the limitations of claims of claim 1 and 5.
Conclusion
4. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Min et al. (2022/0028070) et al. teaches a device for medical image analysis and disease tracking.
Gonzalez et al. (2016/0260210) teaches and method and system for determining the prognosis of patient suffering from pulmonary embolism.
Ross et al. (2013/0004044) teaches a tissue phasic classification mapping system and method.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gabriel I. Garcia whose telephone number is (571) 272-7434. The Examiner can normally be reached Monday-Thursday from 7:30 AM-6:00 PM. The fax phone number for this group is (571) 273-8300.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Benny Tieu can be reached on (571) 272-7490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-2600.
/Gabriel I Garcia/
Primary Examiner, Art Unit 2682
March 27, 2026