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 a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception or sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
Analysis for claims 1 and 12 for subject matter eligibility is as follows:
Step 1: Claims 1 and 12 are drawn to a system, which is a statutory category.
Step 2A – Prong 1: Claims 1 and 12 are drawn to an abstract idea in the form of a process that under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components.
In particular, claims 1 and 12 recite the following limitations:
[A1]: “process a three-dimensional image of a portion of a body of a subject in which multiple brachytherapy seeds grouped into one or more seed groups are implanted, so as to identify clusters of voxels of the image corresponding to the seed groups, respectively”
[B1]: “compute respective estimated positions of the brachytherapy seeds based on respective dimensions of each of the clusters,”
[C1]: “store or communicate the estimated positions for use in computing an effective dose of the brachytherapy seeds”
These elements [A1] – [C1] of claims 1 and 12 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, can be done mentally by a human mind or a human using a pen and paper. A skilled artisan, such as a medical doctor or physicist, can readily visually perceive the clusters in a 3-D image, receive the seed dimension information, calculate/determine the position, and take mental note or record the position on pen and paper.
Step 2A – Prong Two: Claims 1 and 12 do not recite additional elements that integrate the judicial exception into a practice application.
In particular, claim 1 recites the following limitations:
[A2]: “a memory, configured to store program instructions”
[B2] “a processor, configured to: load the program instructions from the memory, and by executing the program instructions”
In particular, claim 12 recites the following limitation:
[C2]: “computer software product comprising a tangible non- transitory computer-readable medium in which program instructions are stored, which instructions, when read by a processor, cause the processor to”
These elements [A2] - [C2] do not integrate the judicial exception in to a practical application. These elements do not integrate the exception into a practical application of the exception because these elements recite instructions for generic computer-implemented steps. Please see Versata 793 F.3d at 1312-13, 115 USPQ2d at 1685 and MPEP 2106.04(a)(2) III C. Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claims 1 and 12 does not recite additional elements that amount to significantly more than the judicial exception itself. Claims 1 and 12 recite the following additional elements:
In particular, claim 1 recites the following limitations:
[A2]: “a memory, configured to store program instructions”
[B2]: “processor, configured to: load the program instructions from the memory, and by executing the program instructions”
In particular, claim 12 recites the following limitation:
[C2]: “computer software product comprising a tangible non- transitory computer-readable medium in which program instructions are stored, which instructions, when read by a processor, cause the processor to”
The elements [A2]-[C2] do not amount to significantly more than the judicial exception itself.
Simply reciting the elements [A2]-[C2] do not qualify as significantly more because these elements are adding well-understood, routine, and conventional activities previously known in the industry, recited at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium both of which are well-understood, routine and conventional activity previously known in the industry. (See MPEP 2106.05(d)(II)). OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)). Additionally, the system described in the specification describes a processor that may belong to a “standard computer”.
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Independent claim 2 recites a method that mirrors steps [A1] – [C1] from claim 1 and is not patent eligible for substantially similar reasons.
Claims 3-11 depend from claim 2, and they recite the same abstract idea as claim 2. Claims 13 -21 depend from claim 12, and they recite the same abstract idea as claim 11. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms).
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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 1, 2, 4-6, 10-12, 14-16, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen, H., Fouard, C., and Troccaz, J. Segmentation, Separation, and Pose Estimation of Prostate Brachytherapy Seeds in CT Images. IEEE Transactions on Biomedical Engineering. Vol. 62, no. 8. (August 8, 2015), pp 2012 – 2024 (cited by applicant on the 6/20/23 IDS) herein referred to as Nguyen.
Regarding claims 1, 2, and 12 Nguyen et al discloses comprising processing a three-dimensional image of a portion of a body of a subject (Table 1, last line titled “proposed method”) in which multiple brachytherapy seeds grouped into one or more seed groups are implanted (Figure 3, pg 2020, section C, paragraph 1), so as to identify clusters of voxels of the image corresponding to the seed groups (pg 2015, column 2, paragraph 1) respectively; computing respective estimated positions of the brachytherapy seeds based on respective dimensions of each of the clusters (pg 2015, column 2, paragraph 1); and storing or communicating the estimated positions (Table IV, columns titled Δθ and Δd) for use in computing an effective dose of the brachytherapy seeds. Nguyen et al further discloses a system comprising a memory configured to store program instructions and processor [of claim 1] and a non-transitory computer readable medium [of claim 12] (pg 2019, column 2, paragraph 1, “the time
evaluation is on a computer of 3.4-GHz Intel Core i7-2600 CPU”).
Regarding claims 4-5 and 14-15, Nguyen teaches processing an image by applying a Bayesian Gaussian mixture model the image (pg 2013, column 2, paragraph 1 “three declustering methods are considered for union-seed separation: the k-means based method and a modified version of it and the Gaussian mixture model (GMM) with an expectation-maximization (EM) algorithm”) and applying a connected-components clustering algorithm (pg 2015, column 2, Here, a threshold-based segmentation method, namely connected component labeling [5] with only an intensity threshold parameter t, is considered to exploit this information for the detection of individual objects in the images”). The examiner is interpreting the “expectation-maximization algorithm” as applying Bayes statistical method of updating probabilities after obtaining new data, therefore making the model a “Bayesian Gaussian Mixture Model”.
Regarding claim 6 and 16, Nguyen teaches computing respective estimated positions of brachytherapy seeds based on respective dimensions of the clusters (pg 2015, column 2, paragraph 1, “We first threshold the original volume with the threshold parameter t, then each connected component (using 26-connectivity) is assigned a label i and ordered by its size. The location of each component is determined as its center of mass ci”), computing the estimated numbers of brachytherapy seeds in the seed groups (pg 2015, Fig. 5), and computing the respective estimated positions based on the respective estimated numbers (pg 2016, Fig. 6).
Regarding claim 10 and 20, Nguyen teaches computing estimated center coordinates (pg 2015, column 2, paragraph 1, “We first threshold the original volume with the threshold parameter t, then each connected component (using 26-connectivity) is assigned a label i and ordered by its size. The location of each component is determined as its center of mass ci”) and estimated orientation vectors of brachytherapy seeds (Fig. 14, pg 2019, column 1, paragraph 1, “The first principal component v1 is the feature space along which projections have the largest eigenvalue λ1 of the covariance matrix C of the point cloud. This is chosen as the orientation of the object”).
Regarding claim 11 and 21, Nguyen teaches receiving a total number of brachytherapy seeds from a user and computing the respective estimated positions of brachytherapy seeds based on total number (Table IV, columns titled “Nb of seeds implanted” and “seeds detected”).
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.
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.
Claim 3 and 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Thornton (US 2004/0049109) (cited by applicant on the 6/20/23 IDS).
Regarding claims 3 and 13, Nguyen teaches the method of claim 2 and the software product of claim 12 but fails to teach displaying at least part of the image with overlaid markers at the estimated positions so as to allow a user to adjust the estimated positions by performing an action selected from the group of actions consisting of: overlaying one or more additional markers, deleting one or more of the markers, and moving one or more of the markers; and computing the effective dose based on the adjusted estimated positions.
Thornton further teaches displaying at least part of the image with overlaid markers at the estimated positions so as to allow a user to adjust the estimated positions by performing an action selected from the group of actions consisting of: overlaying one or more additional markers, deleting one or more of the markers, and moving one or more of the markers; and computing the effective dose based on the adjusted estimated positions (paragraph [0064] “a user interface may be provided that allows the user to modify a calculated seed position. In one embodiment, the user interface may include a field displayed in a screen. The operator may manually type in a position for a particular seed 40 in the field to over-ride the calculated position. Alternatively, the user interface may include a button, which allows the operator to adjust the calculated position of a seed 40”).
It would be prima facie obvious to one of ordinary skill in the art to modify the teachings in Nguyen in view of the teachings in Thornton (user interface to display and adjust markers of brachytherapy seeds). One of ordinary skill would have realized that post processing the images may be necessary of the seed positions in case of errors or inaccuracy (see Nguyen pg 2019, column 1, section 3 titled “evaluation”).
Claims 7-9 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Failla (US 2009/0063110) and Fenster (US 2009/0198094) (both cited by applicant on the 6/20/23 IDS).
Regarding claim 7 and 17, Nguyen teaches computing respective estimated numbers of the brachytherapy seeds in the seed groups (see claim 6 rejection) but fails to teach wherein the computing the estimated number of the seeds comprises computing a length of a main axis and estimating based on the length.
Failla teaches for each of the clusters, computing the estimated number of the brachytherapy seeds in the seed group corresponding to the cluster based on the length (Fig. 8, paragraphs [0056] - [0057] “referring to FIG. 8, a first point source 170a may be located at the centroid of a first radioactive core segment 172, a second point source 170b may be located at the centroid of a second radioactive core segment 174, and a third point source 170c may be located at the centroid of a third radioactive core segment 176” and “each of the point sources 170 may be computed by calculating, through experiment or either a deterministic or stochastic solution method, the photon fluence exiting the brachytherapy source at a corresponding radioactive core section of the brachytherapy source). The examiner is interpreting one point source to be one brachytherapy seed and a plurality of point sources to be a cluster (as shown in figure 8). The examiner is interpreting that by computing the fluence from brachytherapy seeds, the number of seeds in a cluster can be determined and indicate the length of the cluster.
It would be prima facie obvious to one of ordinary skill in the art to modify the teachings in Nguyen in view of the teachings in Failla (computing number of seeds in a cluster based on length). One of ordinary skill in the art would have recognized that since brachytherapy treatment plans are determined in real time that speed and efficiency is important. Simpler methods, such as using the length of the cluster to determine seed position, would allow for both speed and accuracy in treatment planning (see paragraph [0006] in Failla).
However, Failla fails to teach the length being a main axis of the cluster.
Fenster teaches computing a length of a main axis of the cluster (paragraph [0120] “In the bar [Z-axis], all closest points to the line will form a 3D segment…all these line segments are called 3D line segment patterns”). The examiner is interpreting the 3D segment formed by the closest points to the line as the main axis of the cluster.
It would be prima facie obvious to one of ordinary skill in the art to modify the teachings in of Nguyen and Failla (computing the estimated number of the brachy therapy seeds in the seed group corresponding to the cluster based on the length) to incorporate the teachings of Fenster (computing the length of a main axis). One of ordinary skill in the art could see that computing a main axis would help make seed segmentation easier to determine as a user can easily see the seeds along an axis in a 3D image, thus making dose computation more accurate.
Regarding claim 8 and 18, Nguyen teaches computing respective estimated numbers of the brachytherapy seeds in the seed groups (see claim 6 rejection) but fails to teach respective sub-clusters of the voxels corresponding to those of brachytherapy seeds in the seed group are distributed uniformly along the main axis.
Failla teaches respective sub-clusters of the voxels corresponding to those of brachytherapy seeds in the seed group distributed uniformly (paragraph [0059] “In some embodiments one or more threshold distances may be defined for determining the point sources to be derived for a given brachytherapy source 101. For example, the brachytherapy source may be modeled as a single point source for purposes of calculating dose of voxels, or elements, located at distances greater than a first threshold distance” and Fig. 8 shows that the brachytherapy seeds are equally distributed). The examiner is interpreting that the voxels are determined by thresholding and can correspond to one or a group of brachytherapy seeds. Further, since Fig. 8 displays brachytherapy seeds distributed uniformly the examiner is interpreting that clusters of voxels correspond to the brachytherapy seed group and are distributed uniformly.
Regarding claim 9 and 19, Failla further teaches computing the estimated positions of the seeds in the seed groups by segmenting the main axis in to the estimated number of equal-length segments and the sub-clusters are aligned with the main axis and centered on the segments (as shown in Fig. 8).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dehghan Marvast et al (US 2015/0306426) teaches a system that uses ultrasound imaging to determine the brachytherapy seed position.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791