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.
Claim 23 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. Claim 23 uses the phrase “one or more additional markers” but this is the first mention of markers so it is not clear how there are “additional” markers. It is suggested the claim be amended to remove the word “additional”.
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 - 15, 18 – 25 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 - 5, 8 - 15, 18 – 25 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 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 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] – [D1] from claim 1 and is not patent eligible for substantially similar reasons.
Claims 3-5, 8-11, and 24 depend from claim 2, and they recite the same abstract idea as claim 2. Claims 13 -25 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) 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 necessary 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 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.
Allowable Subject Matter
Claim 1-5, 8-15, and 18 -24 would be allowable if amended to overcome the rejection under 35 U.S.C. 101, set forth in this office action.
The following is an examiner’s statement of reasons for allowance:
Nguyen et al (Segmentation, Separation, and Pose Estimation of Prostate Brachytherapy Seeds in CT images) teaches processing a 3D image of a body where estimated positions of brachytherapy seeds are computed based on the respective dimensions of the clusters, but Nguyen estimates the positions by computing the estimated center coordinates and orientation vectors of the brachytherapy seeds. No prior art of record teach estimating the estimated number of seeds by first computing a length of a main axis of the cluster, and then based on the length, computing the estimated number of the brachytherapy seeds in the seed group correspond to the cluster in combination with the rest of the claimed limitations.
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.”
Response to Arguments
U.S.C. 102 and 103
Applicant’s arguments, see page 8-9, filed 2/11/2026, with respect to claims 1, 2, 4-6, 10-12, 14-16, and 20-21, have been fully considered and are persuasive. The rejections of those claims have been withdrawn.
U.S.C. 101
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive.
The applicant argues that the amended claim 1 improves existing techniques for computing estimated positions of brachytherapy seeds, by estimating positions without requiring identifying each individual seed. While the amendments may improve an existing technique, the improvement is in the abstract idea which does not overcome 101. The judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements or the additional elements in combination with the judicial exception.
The applicant continues their argument stating that “claim 1 integrates this “abstract idea” into the practical application of computing an effective dose of brachytherapy seeds, as recited in the last limitation of the claim”. However, claim 1 does not claim computing an effective dose of brachytherapy seeds, it only claims storing the positions, for use in/so that they can be used for computing an effective dose of brachytherapy seeds. Newly added dependent claims 22-25 do add the positive recitation of computing the effective dose, however the step of computing an effective dose of brachytherapy seed is considered to be part of the abstract idea of mental process or a mathematical calculation. Part of the abstract idea cannot integrate itself into a practical application. Step 2A Prong Two, practical application analysis is if the claim recites additional elements to integrate the judicial expectation into a practical application. As stated in the 101 rejections above, the additional elements of the memory processor and computer software product do not integrate the judicial exception into a practical application as they are generic computer elements, merely using a computer as a tool to perform an abstract idea.
For these reasons it is believed the 35 U.S.C. 101 rejection still stands and have been maintained with updates in accordance with claim amendments made.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791