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 § 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 28 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.
Regarding claim 28, The term “abnormally large” in claim 28 is a relative term which renders the claim indefinite. The term “abnormally large” 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. Therefore, it is unclear what defines a “large” amount of seeds let alone an “abnormally large” amount of seeds. For examining purposes, an abnormally large amount of seeds will be considered as more than one.
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 1-5, 8-12, 22, and 24-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. law of nature, natural phenomenon, or an abstract idea) without significantly more. Claims 1-5, 8-12, 22, and 24-33 do not include additional elements that integrate the exception into a practical application of 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: Claim 1 is drawn to a system and claim 12 is drawn to a software which are statutory categories.
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 numbers of the brachytherapy seeds in the seed groups, by, for each of the clusters:
computing a length of a main axis of the cluster, and
based on the length, computing the estimated number of the brachytherapy seeds in the seed group corresponding to the cluster”
[C1]: “compute respective estimated positions of the brachy therapy seeds based on the respective estimated numbers”
[D1]: “store or communicate the estimated positions for use in computing an effective dose of the brachytherapy seeds”
These elements [A1] – [D1] 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, mentally calculate or measure a length of the cluster using the scale of the image, mentally calculate the number of brachytherapy seeds based on the length of a main axis of a cluster (and length of a seed), mentally calculate/determine the position based on the numbers, 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 practical 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, claims 1 and 12 recite 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”
The elements [A2]-[C2] do not amount to significantly more than the judicial exception itself. 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”.. Additionally, the element is well-understood, routine, and conventional as evidenced by Frissen (US 2018/0140869), Fichtinger (US 2008/0262345), and Ribbing (US 2016/0193480).
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] – [D1] from claim 1 and is not patent eligible for substantially similar reasons.
Dependent claims 3-5, 8-11, 22, and 24-33 are also rejected under 35 USC 101 as 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) and/or add additional elements that are not practical application or significantly more. Although specific steps are claimed such as “compute the effective dose based on the estimated positions” this step could be performed by someone skilled in the arts such as a doctor and physicist who can mentally calculate the dose of the brachytherapy seeds based on the positions. Further, the specific steps claimed as “display an image and receive adjusted estimated positions from a user” amounts to insignificant data gathering and outputting. This would be an insignificant extra-solution activity and is not a practical application or significantly more. Please see Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) and MPEP 2106.05 (g).
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 brachytherapy treatment planning systems. 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 § 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(s) 1, 2, 4 - 5, 10- 12, 27 – 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over 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, in view of Macdonald (WO 2019/090429).
Regarding claims 1, 2, and 12 Nguyen teaches
(of claim 1) a memory, configured to store program instructions and a processor configured to load the program instructions from the memory and by executing the program instructions (pg 2019, column 2, paragraph 1, “the time evaluation is on a computer of 3.4-GHz Intel Core i7-2600 CPU” The examiner notes that a CPU would have a processor and a memory that would execute a program.)
(of claim 12) A computer software product comprising a tangible non- transitory computer-readable medium in which program instructions are stored, (pg 2019, column 2, paragraph 1, “the time evaluation is on a computer of 3.4-GHz Intel Core i7-2600 CPU” The examiner notes that a CPU would have a processor and a memory.)
process 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, respectively, compute respective estimated numbers of the brachytherapy seeds in the seed groups (pg
2015, column 2, figure 5 “Compute the number of seeds in each candidate ns where ns>1 are ‘union seeds’” The examiner notes that union seeds are clusters.)
computing the respective estimated positions based on the respective estimated numbers (pg 2016, Fig. 6).
store or communicate the estimated positions for use in computing an effective dose of the brachytherapy seeds (Table IV, columns titled Δθ and Δd)
However, Nguyen fails to teach where for each of the clusters, computing a length of the cluster and based on the length computing the estimated number of the brachytherapy seeds in the seed group corresponding to the cluster.
Macdonald teaches a radiation treatment planning system that calculates length of axes in a three-dimensional volume made of smaller sub-sets. (paragraph [0165] “the processor configured to compute the metric for each of the plurality of subsets comprises the processor configured to determine lengths of axes of a three-dimensional bounding volume enclosing centers of mass of the target volumes of the respective subset and computing a function of the lengths of the axes.” Paragraph [0081] “the processor configured to generate a starting grouping of subsets by assigning each target volume of the set of target volumes to one of a plurality of subsets in an order.” The examiner is modifying the system of Nguyen to calculate the length of an axis of a cluster (a 3-d image of voxels) and compute a function (volumes for each of a plurality of subsets) based on the axis length. The examiner is interpreting each of the subsets to be a seed. Thus, when modified the combined system of Nguyen and Macdonald for each of the clusters, computes a length of the cluster and based on the length computing the estimated number of the brachytherapy seeds in the seed group corresponding to the cluster.)
It would be prima facie obvious to one of ordinary skill in the art to modify the teachings in of
Nguyen (computing the estimated number of the brachy therapy seeds in the seed group) to incorporate the teachings of Macdonald (computing the length of a main axis, calculating functions based on the axis to identify smaller subsets within a bounded area). 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 4, Nguyen and MacDonald teach the method according to claim 2, and Nguyen further teaches wherein processing the image comprises processing the image by applying a Bayesian Gaussian mixture model to 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” 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 5, Nguyen and MacDonald teach the method according to claim 2, and Nguyen further teaches wherein processing the image comprises processing the image by applying a connected-components clustering algorithm to the image. (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 ”).
Regarding claim 10, Nguyen and MacDonald teach the method according to claim 2, and further teaches wherein computing the estimated position comprises 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, Nguyen and MacDonald teaches the method of claim 2, wherein computing the respective estimated positions of the brachytherapy seeds comprises: 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”)
Regarding claim 27, Nguyen and MacDonald teach the method of claim 2, and Nguyen further teaches wherein processing the image comprises processing the image by applying one or more clustering algorithms to the image. (page 2017, column 1 “The k-means clustering method is again used for the voxel locations of each union-seed to separate it.”)
Regarding claim 28, Nguyen and MacDonald teach the method of claim 2, and Nguyen further teaches wherein applying the clustering algorithms comprises: applying a first clustering algorithm to the image; and in response to the first clustering algorithm returning an abnormally large cluster corresponding to multiple adjacent ones of the seed groups, applying a second clustering algorithm to the image to differentiate between the adjacent ones of the seed groups (pg 2017, column 2, under “using the GMM and the EM algorithm” “In some cases, the k-means-FS method does not give optimal results; thus, we also consider a GMM in order to improve the clustering of complicated union-seeds containing four or five seeds”.
Regarding claim 29, Nguyen and MacDonald teach the method of claim 27, and Nguyen further teaches further comprising binarizing the image, by applying a threshold to the image, prior to applying the clustering algorithms. (pg 2020, column 2, paragraph 2 “In this experiment, we ran the proposed method with different values of the intensity threshold t” The examiner notes that thresholding is binarizing an image as noted in the claim and the proposed method is applying the two clustering algorithms (Gauss Mixture Model and K-clustering).)
Regarding claim 32, Nguyen and MacDonald teach the method according to claim 11, and Nguyen further teaches (pg 2018, column 1, paragraph 1 “At each iteration of the EM algorithm, we compute the expected values of the unknown data given the observed data and the current
model parameters in the expectation (E) step. The maximization (M) step involves optimizing and updating the parameters to be those with maximum likelihood. It can be shown that the loglikelihood was improved at each such iteration. This process is stopped if a local maximum has been reached or some stopping criterion is met.” The examiner is interpreting the local maximum as a total number of seeds.)
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of MacDonald in view of Failla (US 2009/0063110) further in view of Thornton (US 2004/0049109) (cited by applicant on the 6/20/23 IDS).
Regarding claim 3, Nguyen, MacDonald, and Failla teach the method of claim 24 but fail to teach displaying at least part of the image with overlaid markers at the estimated positions; andreceiving, from a user, an adjustment to the estimated positions performed via 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, wherein computing the effective dose comprises computing the effective dose based on the adjusted estimated positions.
Thornton further teaches a brachytherapy seed localization system that displays 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”).
Claim(s) 22, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of MacDonald in view of Failla (US 2009/0063110).
Regarding claims, 22 and 24-25, Nguyen and MacDonald teach the system according to claim 1, the method according to claim 2, and the computer software product of claim 12 but fails to teach computing the effective dose based on the estimated positions.
Failla teaches a brachytherapy dose computation system and method that Compute the effective dose based on the estimated positions (paragraph [0042] “The dose computation process computes radiation dose for each grid element of a select treatment volume….the types, positions, and numbers of brachytherapy sources to be used to treat a patient may be varied and tested to identify a most effective brachytherapy source configuration” The examiner notes the grid element is a position.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by Nguyen and MacDonald to calculate the most effective dose based on positions as taught by Failla. One of ordinary skill would have been able to recognize that achieving the desired treatment at the target location is necessary while minimizing radiation to safe levels at critical structures 103 and surrounding tissue. See paragraph [0042] of Failla.
Regarding claim 26, Nguyen, MacDonald, and Failla teach the method of claim 24, and Failla further teaches wherein computing the effective dose facilitates a decision as to whether to move the brachytherapy seeds and/or to implant additional brachytherapy seeds. (paragraph [0116] “During HDR and PDR treatments, an afterloader may incrementally move a single source, attached to a wire, to each specified position for the corresponding dwell time.”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by Nguyen and MacDonald to calculate the most effective dose based on positions as taught by Failla. One of ordinary skill would have been able to recognize that the initial position of the brachytherapy seed may provide an inaccurate dose and therefore would need to be adjusted.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of MacDonald in view of Tan (US 2015/0078641).
Regarding claim 33, Nguyen and MacDonald teach the method according to claim 32, but fail to teach wherein applying the successive clustering algorithms comprises removing, from the image, any of the clusters identified by a first clustering algorithm and for which the positions were estimated, prior to applying a second clustering algorithm.
Tan teaches a segmentation technique that removes data not of interest in an image. (paragraph [0077] “the described procedure also includes preprocessing the original set of image data to remove the portions of voxels or pixels not of interest” The examiner is modifying the system as taught by Nguyen and Macdonald to do this step in between clustering algorithms as it is intended to be pre-processing.)
It would be prima facie obvious to one of ordinary skill in the art to modify the system as taught by Nguyen and MacDonald to remove the clusters in between the clustering algorithms as taught by Tan. One of ordinary skill would have been able to recognize that if the clusters were not removed prior to additional image processing, this may result in inaccurate positions of brachytherapy seeds and thus dose values.
Allowable Subject Matter
Claims 8-9 and 30-31 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action and if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Nguyen and MacDonald teach a system to process images to calculate a length of an axis and brachytherapy seed positions in a specific area but neither Nguyen or MacDonald nor any other prior art discovered teaches or makes obvious distributing voxels along the main axis, segmenting the main axis, checking whether the length of a main axis is within a predefined range, and calculating the predefined range based on known constants.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Binnekamp (US 2013/0102891) teaches a method for guided adaptive brachytherapy.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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