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 .
DETAILED ACTION
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 12/12/2024 has been considered by Examiner and made of record in the application file.
Double Patenting
2. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 e Terminal Disclaimer may be filled out completely online using web-screens. An e Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e Terminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
3. Claims 1, 4-9, 10-12, 13-14, 15-18, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-7, 9-11, 2-3, 4-7, 18 and 2 respectively of U.S. Patent No. 12,141,968. Although the conflicting claims are not identical, they are not patentably distinct from each other because all the claimed limitations are transparently found in the U.S. Patent No. 12,141,968 with obvious wording variations as shown in the following table.
U.S. Patent No. 12,141,968
Application No. 18/909,867
1. A computer-implemented method comprising: for each sample of a first set of samples collected from a subject at a first period of time, receiving data input comprising dimensions of a sample area of the sample, a percentage of the sample area of the sample comprising viable cells, and a percentage of the sample area of the sample comprising necrosis;
1. A computer-implemented method comprising: for each sample of a set of samples, receiving data input comprising dimensions of a sample area of the sample, a percentage of the sample area of the sample comprising viable cells, a percentage of the sample area of the sample comprising necrosis;
for each sample of the first set of samples, computing a percentage of the sample area of the sample comprising stroma based on the respective percentages of the sample area of the sample comprising viable cells and necrosis;
for each sample of the set of samples, computing a percentage of the sample area of the sample comprising stroma based on the respective percentages of the sample area of the sample comprising viable cells and necrosis;
for each sample of the first set of samples, computing weighting factors based on at least the dimensions of the sample area of the sample;
for each sample of the set of samples, computing weighting factors based on the dimensions of the sample area of the sample and at least one of a mass of the sample relative to a tissue block from which it was taken, a density of the sample relative to that of the tissue block, and a position of the sample in the tissue block;
computing a weighted percentage of the first set of samples comprising viable cells based on the computed weighting factor and percentage of the sample area of each sample of the first set of samples comprising viable cells;
computing a weighted percentage of the set of samples comprising viable cells based on the computed weighting factor and percentage of the sample area of each sample of the set of samples comprising viable cells;
determining that a specified condition is detected in the first set of samples based on the computed weighted percentage of the first set of samples comprising viable cells satisfying a threshold correlating with an indication of the specified condition;
and determining that a specified condition is detected in the set of samples based on the computed weighted percentage of the set of samples comprising viable cells satisfying a threshold correlating with an indication of the specified condition.
determining that the specified condition is detected in a second set of samples collected from the subject at a second period of time based on a second computed weighted percentage of the second set of samples comprising viable cells satisfying the threshold correlating with the indication of the specified condition;
and computing a difference in the weighted percentage of samples collected from the subject comprising viable cells over time based on a difference between the computed weighted percentage of the first set of samples comprising viable cells and the second computed weighted percentage of the second set of samples comprising viable cells.
U.S. Patent No. 12,141,968 Application No. 18/909,867
2-7, 9-11, 2-3, 4-7, 18 and 2. 4-9, 10-12, 13-14, 15-18, 19 and 20.
Consider claim 2, U.S. Patent No. 12,141,968 teaches all limitations of claim 1 except does not explicity teaches wherein the data input received for each sample of the set of samples comprises at least one of a mass of the sample, a density of the sample, and a position of the sample in the tissue block.
However, Pataer et al. ("Histopathologic Response Criteria Predict Survival of Patients with Resected Lung Cancer After Neoadjuvant Chemotherapy," Journal of Thoracic Oncology, [on line] vol. 7, no.5, pages 825-832, May 31, 2012, hereinafter “Pataer”; provided by an Applicant’s IDS filed on 12/12/2024) teaches wherein the data input received for each sample of the set of samples comprises at least one of a mass of the sample, a density of the sample, and a position of the sample in the tissue block (figure 1, "% Stramal tissue").
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the claimed invention was made to use, wherein the data input received for each sample of the set of samples comprises at least one of a mass of the sample, a density of the sample, and a position of the sample in the tissue block, in order for evaluated the ability of histopathologic response criteria to predict overall survival and disease-free survival in patients with surgically resected non-small cell lung cancer treated with or without neoadjuvant chemotherapy.
Consider claim 3, Pataer further wherein the threshold is determined based on the specified condition, a number of samples in the set of samples, a quality of the samples in the set of samples, physical characteristics of the samples in the set of samples, or any combination thereof (figure 1, pages 825-826 section “Histopathologic Evaluation”).
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Pataer in view of Geschwind et al. ("Chemoembolization of Liver Tumor in a Rabbit Model: Assessment of Tumor Cell Death with Diffusion-Weighted MR Imaging and Histologic Analysis," Journal of Vascular and Interventional Radiology, vol. 11, no. 10, pages 1245-1255, November 30, 2000, hereinafter “Geschwind”; provided by an Applicant’s IDS filed on 12/12/2024).
Consider claim 1, Pataer teaches a computer-implemented (figure 1) method comprising: for each sample of a set of samples, receiving data input comprising dimensions of a sample area of the sample (figure 1, slides a-j, greatest tumor diameters "5-10mm"), a percentage of the sample area of the sample comprising viable cells, a percentage of the sample area of the sample comprising necrosis (figure 1, pages 825-826 section “Histopathologic Evaluation”, "% Viable tumor cells", “% Necrosis”, “The percentage of residual tumor was estimated by comparing the estimated cross-sectional area of the viable tumor foci with estimated cross-sectional areas of necrosis, fibrosis, and inflammation on each side."; emphasis added); for each sample of the set of samples, computing a percentage of the sample area of the sample comprising stroma based on the respective percentages of the sample area of the sample comprising viable cells and necrosis (figure 1, "% Stramal tissue"); and determining that a specified condition is detected in the set of samples based on the computed weighted percentage of the set of samples comprising viable cells satisfying a threshold correlating with an indication of the specified condition (figure 1, pages 825-826 section “Histopathologic Evaluation”, “The results for all slides were averaged together to determine the mean values for each patient"; also see Table 2, histopathologic changes (conditions) by percentage of viable tumor cells, e.g. 0-10%).
Pataer does not explicitly show that for each sample of the set of samples, computing weighting factors based on the dimensions of the sample area of the sample and at least one of a mass of the sample relative to a tissue block from which it was taken, a density of the sample relative to that of the tissue block, and a position of the sample in the tissue block; computing a weighted percentage of the set of samples comprising viable cells based on the computed weighting factor and percentage of the sample area of each sample of the set of samples comprising viable cells.
In the same field of endeavor, Geschwind teaches ; for each sample of the set of samples, computing weighting factors based on the dimensions of the sample area of the sample (page 1247, section "Histological Preparation”) and at least one of a mass of the sample relative to a tissue block from which it was taken, a density of the sample relative to that of the tissue block, and a position of the sample in the tissue block; computing a weighted percentage of the set of samples comprising viable cells based on the computed weighting factor and percentage of the sample area of each sample of the set of samples comprising viable cells (page 1247, section "Histological Preparation” i.e., in the context of a similar histological evaluation involving the determination of the fraction of viable tumor cells remaining after treatment: "The overall percentage of viable tumor in each rabbit was calculated based on the average of viable tumor in each slice, weighted for the tumor area per slice”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention was made to use, for each sample of the set of samples, computing weighting factors based on the dimensions of the sample area of the sample and at least one of a mass of the sample relative to a tissue block from which it was taken, a density of the sample relative to that of the tissue block, and a position of the sample in the tissue block; computing a weighted percentage of the set of samples comprising viable cells based on the computed weighting factor and percentage of the sample area of each sample of the set of samples comprising viable cells, as taught by Geschwind, in order to assess the efficacy of chemoembolization of liver tumors by determining the fraction of viable tumor cells remaining after treatment with use of diffusion magnetic resonance imaging and histologic analysis.
Consider claim 2, Pataer further teaches wherein the data input received for each sample of the set of samples comprises at least one of a mass of the sample, a density of the sample, and a position of the sample in the tissue block (figure 1, "% Stramal tissue").
Consider claim 3, Pataer further wherein the threshold is determined based on the specified condition, a number of samples in the set of samples, a quality of the samples in the set of samples, physical characteristics of the samples in the set of samples, or any combination thereof (figure 1, pages 825-826 section “Histopathologic Evaluation”).
Consider claim 4, Pataer further teaches computing an average non-weighted percentage of the set of samples comprising viable cells; and determining that the specified condition is detected in the set of samples based on the computed average non-weighted percentage of the set of samples comprising viable cells satisfying a second threshold correlating with the indication of the specified condition (figure 1, pages 825-826 section “Histopathologic Evaluation”, “The results for all slides were averaged together to determine the mean values for each patient"; also see Table 2, histopathologic changes (conditions) by percentage of viable tumor cells, e.g. 0-10%).
Consider claim 5, Pataer further teaches assessing a reliability of the determination that the specified condition is detected in the set of samples based at least in part on a comparison between the computed weighted percentage of the set of samples comprising viable cells and the computed average non-weighted percentage of the set of samples (page 827, section “Histopatho!ogk Features in Patients Treated
with and without Neoadjuvant Chemotherapy”).
.
Consider claim 6, Geschwind further teaches computing clinical population metrics based on the weighted percentage of a plurality of sets of samples comprising viable cells, each set of samples corresponding to a member of the clinical population (page 826, section, “Statistical Analysis”).
Consider claim 7, Pataer further teaches receiving the data input comprises detecting one or more sources of error in the received data input, the sources of error comprising: a percentage greater than 100%; missing data values; incomplete data values; dimensions of the sample area failing to satisfy a threshold sample area; the mass of the sample failing to satisfy a threshold sample mass; the density of the sample failing to satisfy a threshold sample density; or received data input values exceeding a specified range, where the specified range is based on other received data values (page 1253, left column, i.e., motion artifacts can he further reduced by the use of navigator echoes, which are useful to correct the phase errors in MR data caused by macroscopic motions of the organ to be imaged (31, 32)).
Consider claim 8, Geschwind further teaches in response to detecting one or more sources of error, displaying a prompt to instruct an operator to correct the detected source of error (page 1253, left column, i.e., motion artifacts can he further reduced by the use of navigator echoes, which are useful to correct the phase errors in MR data caused by macroscopic motions of the organ to be imaged (31, 32)).
Consider claim 9, Pataer further teaches requesting an operator to review the data input, computed percentage of the sample area comprising stroma, and weighted percentage of the first set of samples comprising viable cells (figure 1, "% Stramal tissue").
Consider claim 10, the subject-matter of independent claim 10 relates to a method comprising: by one or more computing devices with features fully corresponding to the characteristics of claim 1. Therefore, the same argumentation presented in relation to claim 1 is, mutatis mutandis, of application to claim 10.
Consider claim 11, Pataer further teaches wherein assessing the one or more images corresponding to each sample comprises applying one or more computer vision models to the one or more images (figure 1, pages 825-826 section “Histopathologic Evaluation”).
Consider claim 12, Pataer further teaches prior to determining that a specified condition is detected in the set of samples, displaying a prompt to request an operator to review the determined percentages and one or more images (figure 1, pages 825-826 section “Histopathologic Evaluation”).
Consider claim 13, the previous rejections of claim 4 apply mutatis mutandis to corresponding claim 13.
Consider claim 14, the previous rejections of claim 5 apply mutatis mutandis to corresponding claim 14.
Consider claim 15, the previous rejections of claim 6 apply mutatis mutandis to corresponding claim 15.
Consider claim 16, the previous rejections of claim 7 apply mutatis mutandis to corresponding claim 16.
Consider claim 17, the previous rejections of claim 8 apply mutatis mutandis to corresponding claim 17.
Consider claim 18, the previous rejections of claim 9 apply mutatis mutandis to corresponding claim 18.
Consider claim 19, the subject-matter of independent claim 19 relates to a system with features fully corresponding to the characteristics of claim 1. Therefore, the same argumentation presented in relation to claim 1 is, mutatis mutandis, of application to claim 19.
Consider claim 20, the previous rejections of claim 4 apply mutatis mutandis to corresponding claim 20
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tuan H. Nguyen whose telephone number is (571) 272-8329. The examiner can normally be reached on 8:00Am - 5:00Pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pan Yuwen can be reached on (571) 272-7855. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/TUAN H NGUYEN/Primary Examiner, Art Unit 2649
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