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 Status
Claims 1-10, 12-17, 19-48, 50-55, 57-86, 88-93, and 95-114 are pending and examined on the merits.
Claims 11, 18, 49, 56, 87, and 94 are cancelled.
Priority
The instant application claims priority to US Provisional Application 63/014,226, filed 04/23/2020. As such, the effective filing date of claimed invention is 04/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the list of cited references was considered in full by the examiner. A signed copy of the corresponding 1449 form has been included with this Office action.
Withdrawn Rejections/Objections
Rejections and/or objections not reiterated from previous office actions are hereby
withdrawn in view of the amendments filed 11/19/2025.
All rejections of claims 11, 18, 49, 56, 87, and 94 are hereby withdrawn; their cancelation moots the rejections.
The following rejections and/or objections are either maintained or newly applied. They constitute the complete set presently being applied to the instant application.
Objections
Claim 18 is objected to because of the following informalities:
Cancelled claim 18 recites “s.” which should be removed. Appropriate correction is required.
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 1-10, 12-17, 19-48, 50-55, 57-86, 88-93, and 95-114 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claims 1-10, 12-17, and 19-38 being representative) is directed to a system, a method (claims 39-48, 50-55, and 57-76 being representative), and a computer readable medium (claims 77-86, 88-93, and 95-114 being representative). Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 1-10, 12-17, 19-48, 50-55, 57-86, 88-93, and 95-114 recite the following steps which fall under the mathematical concepts, mental processes, and/or certain methods of organizing human activity groupings of abstract ideas:
Claims 1, 39, and 77 recite determining at least one time-dependent dose for each voxel of at least one organ of said subject within said nonspherical simulation model; the limitation determining a dose using a simulation model/mathematical model, is considered a mathematical calculation, and as such, falls into mathematical concepts groupings of abstract ideas (also, mental process of determining based on the result of a mathematical calculation/simulation).
Claims 1, 39, and 77 further recite creating a blood flow model, including nonuniform blood velocities calculated from said subject data and organ-specific cardiac output, for said at least one organ of said subject within said simulation model; the limitation creating a blood flow model is considered a mathematical calculation since it involves calculating the approximate cross-sectional area, as claimed in claims 23, 61, and 99. As such, said limitation falls within mathematical concepts groupings of abstract ideas.
Claims 1, 39, and 77 further recite simulating the delivery of a radiation dose to moving blood within said subject's body within said nonspherical simulation model using said at least one time-dependent dose for each voxel of said at least one organ of said subject and said blood flow model; the limitation simulating delivery involves mathematical calculation of calculating the approximate cross-sectional area, as stated above. As such, said limitation falls within mathematical concept groupings of abstract ideas.
Claims 1, 39, and 77 further recite determining at least one absorbed dose value for said subject's lymphocyes within said simulation model; the limitation determining absorbed dose value is considered a mathematical calculation, as disclosed in instant application (pg.14; “the absorbed dose value, is calculated and stored in the blood voxel matrix”), as such, said limitation falls within mathematical concepts groupings of abstract ideas.
Claims 1, 39, and 77 further recite calculating a remaining count of lymphocytes; the limitation calculating count of lymphocytes is considered a mathematical calculation, and as such falls within mathematical concepts groupings of abstract ideas.
Claims 13-17, 51-55, and 89-93 recite determining at least one absorbed dose value (mathematical concept, see above).
Claims 26-28, 64-66, and 102-104 recite an average blood density per voxel is determined for said at least one organ of said subject using a formula; the limitation of determining an average blood density per voxel is considered a mathematical formula, and as such falls within mathematical concepts groupings of abstract ideas.
Claims 30, 68, and 106 recite determining blood cell sub type count by a formula; the limitation determining blood cell sub type count formula is considered a mathematical formula, and as such, falls within mathematical concepts groupings of abstract ideas.
Claim 32, 70, and 108 recite fitting at least one cell kill model to said subject data (mathematical calculation of fitting a model to data/mathematical concepts).
Claim 34, 72, and 110 recite cell kill model is an exponential function using the linear-quadratic model determined by a formula (mathematical formula/mathematical concepts).
Claim 37, 75, and 113 recite fitting at least one cell kill model to a measured LYA reduction wherein the absolute value of said at least one cell kill model and said measured LYA reduction is decreased (mathematical calculation of fitting a model to data/mathematical concepts).
Claims 38, 76, and 114 recite plotting kill probability function against the measurement day of said subject to calculate the slope of the trend line (mathematical calculation of a slope/mathematical concepts).
Claims 7-11, 19-25, 29, 31, and 33 provide additional information about the abstract ideas.
The identified claims recite a law of nature, a natural phenomenon (product of nature) or fall into one of the groups of abstract ideas of mathematical concepts, mental processes, and/or certain methods of organizing human activity for the reasons set forth above. See MPEP 2106.04 (a)(2) III and MPEP 2106.04 (b) I. Therefore, claims are directed to a judicial exception and require further analysis in Prong Two. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
The additional elements of claims 1-114 include the following.
Claims 1, 39, and 77 recite a computer processor; a memory configured to store instructions that are executable by said computer processor, wherein said computer processor is configured to execute the instructions; importing subject data into a simulation model; transmitting said remaining blood cell sub type count to a secondary source; a non-transitory, computer readable storage medium having instructions stored thereon
Claims 2, 40, and 78 recite secondary source includes one or more of anyone of the following: local memory; remote memory; or display or graphical user interface.
Claims 3, 41, and 79 recite one computer.
Claims 4, 42, and 80 recite a server coupled to a network; a user interface coupled to said network; and an application coupled to said server and/or said user interface, wherein the application is configured for executing said computer processor.
Claims 5, 43, and 81 recite a main memory and a static memory.
Claims 6,44, and 82 recite memory comprises one or more of anyone of the following: electrically programmable read-only memory; electrically erasable programmable read-only memory; flash memory drive; magnetic disk; internal hard disk; external hard disk; removable disk; magneto-optical disk; CD-ROM disk; or DVD-ROM disk
The additional elements of a system comprising a processor, a non-transitory computer-readable storage medium, memory, a display, a user interface, and executable instructions are generic computer components and/or processes. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
Furthermore, the additional elements of importing data and transmitting data amounts to necessary data gathering and outputting.
Furthermore, the additional element of an application coupled to a server and a server coupled to a network being used in their ordinary capacity are merely tools to execute the abstract idea and do not integrate a judicial exception into a practical application.
Therefore, these additional elements amount to insignificant extra-solution activity, which is not sufficient to integrate the recited judicial exception into a practical application. See MPEP 2106.05(g).
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. An inventive concept cannot be furnished by an abstract idea itself. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
The additional elements of claims 1-114 include the following.
Claims 1, 39, and 77 recite a computer processor; a memory configured to store instructions that are executable by said computer processor, wherein said computer processor is configured to execute the instructions; importing subject data into a simulation model; transmitting said remaining blood cell sub type count to a secondary source; a non-transitory, computer readable storage medium having instructions stored thereon
Claims 2, 40, and 78 recite secondary source includes one or more of anyone of the following: local memory; remote memory; or display or graphical user interface.
Claims 3, 41, and 79 recite one computer.
Claims 4, 42, and 80 recite a server coupled to a network; a user interface coupled to said network; and an application coupled to said server and/or said user interface, wherein the application is configured for executing said computer processor.
Claims 5, 43, and 81 recite a main memory and a static memory.
Claims 6,44, and 82 recite memory comprises one or more of anyone of the following: electrically programmable read-only memory; electrically erasable programmable read-only memory; flash memory drive; magnetic disk; internal hard disk; external hard disk; removable disk; magneto-optical disk; CD-ROM disk; or DVD-ROM disk
The additional elements of a system comprising a processor, a non-transitory computer-readable storage medium, memory, a display, a user interface, and executable instructions are conventional computer components and/or processes. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TU Communications LLC v. AV Auto, LLC, 823 F.3d 607,613,118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Furthermore, the additional elements of importing data and transmitting data amounts to necessary data gathering and outputting.
Furthermore, the additional element of an application coupled to a server and a server coupled to a network being used in their ordinary capacity are merely tools to execute the abstract idea and do not amount to significantly more. See MPEP 2106.05 (f) (2).
Therefore, the additional element is not sufficient to amount to significantly more than the judicial exception.
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive. Applicant states:
Applicant respectfully notes that the claim limitation the Office Action asserts as reciting a mental process cannot, as a practical matter, be performed entirely in a human's mind. The claims, as amended, are not directed to "determining at least one time- dependent dose." The claims, as amended, require at minimum "determining from said subject data at least one time-dependent dose for each voxel of at least one organ of said subject within said nonspherical simulation model." (Emphasis added.)
In short, a person cannot mentally determine from the subject data a dose for each voxel in any practical manner as required by a plain reading of the claims. Such actions require, even with pen and paper, the ability to mentally maintain a three-dimensional model of complicated shape and volume as well as mentally apply radiation doses from varying angles and with varying intensities as stipulated, indicated, or implied by the subject data. Additionally, much like a picture is stored as a two-dimensional computer data structure composed of pixels, the simulation model is stored as a three-dimensional computer data structure composed of voxels. As such, determining from the subject data a dose for any or each voxel of a three-dimensional nonspherical simulation model made of voxels inherently involves the "manipulation of computer data structures" that the Federal Circuit held "could not, as a practical matter, be performed entirely in a human's mind." CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1376 (Fed. Cir. 2011).
It is respectfully submitted that above statements are not persuasive. The Applicant remarks are directed to Step 2A Prong One of 101 analysis, specifically that whether the claims recite a judicial exception.
As stated above, the limitation determining a dose using a simulation model/mathematical model, is considered a mathematical calculation/ mathematical concept. Additionally, the limitation of determining using a model, is considered a mental process of determining based on the result of a mathematical calculation/simulation (emphasis added). The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a computer) to perform the claim limitation. See MPEP 2106.04(a)(2) III. B. & C.
Applicant further states:
Applicant respectfully argues that claims 1, 39, and 77, as amended and as a
whole, integrate the asserted judicial exceptions into an improvement to a technology or technical field. The Supreme Court held in Alice Corp. Pty. Ltd.vCLS BankIntern., 573 U.S. 208, 223 (2014) that claims that applied abstract ideas "in a process designed to solve a technological problem" were patent eligible. Following that reasoning, the Federal Circuit held in Amdocs (Israel) Ltd.v Openet Telecom, Inc., 841 F.3d 1288, 1303 (Fed. Cir. 2016), that "[w]hile some individual limitations arguably may be generic, others are unconventional and the ordered combination of these limitations yields an inventive concept sufficient" for patent eligibility. (Emphasis added.)
Applicant respectfully notes that claims 1, 39, and 77, as amended, recite the
additional elements the Examiner noted in the Office Action, (Office Action, pg. 6-7), but recite them, along with the asserted abstract ideas, in such an ordered combination that the claim as a whole is integrated into an improvement to the technical field of estimating post-treatment count of lymphocytes for radiation therapy.
Applicant also respectfully asserts that claims 1, 39, and 77, as amended, also contain meaningful limitations as stipulated in MPEP § 2106.5(e). In Alice, 573 U.S. at 225, the Supreme Court determined that the mere application of an abstract idea, in particular, the "idea of intermediated settlement," on a computer, did not constitute sufficient limitation. Similarly, as noted by the Supreme Court in Diamond v. Diehr, 450 U.S. 175, 191 (1981), abstract ideas such as "mathematical formula[e]... [are] not accorded the protection of our patent laws." However, the Supreme Court also held that sufficient limitations of the use of such abstract ideas to practical applications would be "deserving of patent protection," id. at 187, such as a limitation of an equation "to the practical application of molding rubber products." Id. at 184. Applicant also respectfully notes that "even in the situation where the individually-viewed elements do not add significantly more or integrate the exception, those additional elements when viewed in combination may render the claim eligible." MPEP §2106.5(e). For instance, the Federal Circuit in Thales Visionix Inc. v. United States, 850 F.3d 1343, 1349 (Fed. Cir. 2017), held that even though "a mathematical equation is required to complete the claimed method and system," that does not "doom the claims to abstraction" as the claims specified a "particular configuration" and "particular method" to create an improved or new and useful technique. As such, claims 1, 39, and 77, as amended, involve, in combination, a highly specific step-by-step application of additional elements and any abstract ideas the Examiner asserts to a specific end, being that of estimation of the post- treatment count of lymphocytes, an improved or new and useful technique. Applicant further emphasizes that none of the claims are directed to the general usage of any such asserted abstract idea in accordance with the principle set out by the Supreme Court in Diamond and Alice; the general concept and use of the underlying asserted abstract ideas remain outside the scope of the claims, which are "[f]ar from claiming the [abstract ideas] themselves." Thales Visionix Inc., 850 F.3d at 1349. In conclusion, Applicant respectfully concludes that claims 1, 39, and 77, as amended, are patentable under Step 2A, Prong 2.
It is respectfully submitted that the above statements are not persuasive. The Applicant remarks are directed to Step 2A Prong Two of 101 analysis, specifically whether the additional elements integrate the recited judicial exception into a practical application of the exception.
With regards to Applicant stating that “the claim as a whole is integrated into an improvement to the technical field of estimating post-treatment count of lymphocytes for radiation therapy”, Examiner submits that taken as a whole, the claims are interpreted as being directed to mental and/or mathematical calculations related to estimating lymphocyte counts/a judicial exception(s). It is important to note, the judicial exception alone cannot provide the improvement (See MPEP 2106.04(d) III). The improvement must be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)).
With regards to Applicant asserting that that “claims 1, 39, and 77, as amended, also contain meaningful limitations” by referring to Diamond v. Diehr, Examiner submits that the claim of Diehr was directed to the use of the Arrhenius equation (an abstract idea or law of nature) in an automated process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4, which contained additional elements such as the steps of installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time, and found them to be meaningful because they sufficiently limited the use of the mathematical equation to the practical application of molding rubber products (emphasis added). See MPEP 2106.05(e).
In contrast to claims of Diehr, none of the additionally recited elements in the instant claims integrate the judicial exception(s) into a practical application. Specifically instant claims recite the additional elements of a system comprising a processor, a non-transitory computer-readable storage medium, memory, a display, a user interface, and executable instructions which are generic computer components and/or processes that do not integrate the judicial exceptions into a practical application. Instant claims further recite the additional element of importing data and transmitting data amounts to necessary data gathering and outputting, which do not integrate the judicial exception into a practical application. Instant claims further recite the additional element of application coupled to a server and a server coupled to a network being used in their ordinary capacity are merely tools to execute the abstract idea and do not integrate a judicial exception into a practical application. Therefore, in contrast to claims of Diehr, the additionally recites elements are not sufficient to amount to significantly more than the judicial exception.
With regards to applicant referring to Thales Visionix for rendering the claim eligible, Examiner submits that the claims of Visionix are directed to unconventional /particular configuration of inertial sensors (unconventional additional element) and a particular method of using raw data from the sensors to perform their calculations, as a result, it renders the claims subject matter eligible. See MPEP 2106(a)(2) I.
On the other hand, the present claimed invention is directed to estimating lymphocytes count using generic and conventional computer system components and processes, and therefore, not subject matter eligible.
Applicant further states:
Further under Step 2B Analysis, Applicant also respectfully contends that the additional elements do not fall under insignificant extra-solution activity. with the Examiner's assertion that the additional elements amount to insignificant extra-solution activity. Under MPEP § 2106.5(f), claims 1, 39, and 77, as amended, recite details of how a solution to a problem is accomplished. As stated above, the claims provide a specific step-by-step application of elements to accomplish the solution of estimation of the post- treatment count of lymphocytes. Further, under MPEP § 2106.5(f), claims 1, 39, and 77, as amended, are not existing processes merely invoked on computers or other machinery, and are particular and not broad. The claims also are not directed to a highly general or abstract idea and its mere implementation on computers or machinery "without any recitation of details of how to carry out the abstract idea," id., nor are they directed to highly general or abstract ideas whose steps are carried out by computers or other machinery in their ordinary capacity. In re TLI Commc'ns LLC Pat. Litig., 823 F.3d 607, 615 (Fed. Cir. 2016). Lastly, the claims are particular and not broad, as stated previously.
It is respectfully submitted that these are not persuasive. The Applicant remarks are directed to Step 2B of 101 analyses, specifically evaluating additional elements to determine whether they amount to an inventive concept by considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.
With respect to determining whether the claim recites an inventive concept, the MPEP states: “an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).”. in Instant claims. As stated above, the limitations of determining, creating, simulating, determining, and calculation are considered abstract ideas, and therefore, a judicial exception. In instant claims, elements that are recited in the claims in addition to (beyond) the judicial exception are: a system comprising a processor, a non-transitory computer-readable storage medium, memory, a display, a user interface, executable instructions, importing data and transmitting data, application coupled to a server and a server coupled to a network. As stated above, said additional elements are well-understood, routine, and conventional and are not sufficient to amount to significantly more than the judicial exception. The presently claimed invention is directed to an abstract idea of estimating lymphocytes count using mental and/or mathematical processes and merely uses conventional general-purpose computer components and processes as a tool to perform the process and therefore not subject matter eligible. Taken alone, the additional elements do not amount to significantly more than the identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself.
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
As such, the rejection of claims under U.S.C. 101 is maintained.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10, 12-17, 19, 29, 39-48, 50-57, 67, 77-86, 88-93, 95, and 105 are rejected under 35 U.S.C. 103 as being unpatentable over Ellsworth (WO2015116932A2) in view of Ellsworth et al. (Comprehensive Analysis of the Kinetics of Radiation-Induced Lymphocyte Loss in Patients Treated with External Beam Radiation Therapy, November 1, 2019, Radiation Research Society 193 (1): 73-81), hereinafter refer to as “Ellsworth 2019” and further in view of Hammi et al. (Four-dimensional Blood Flow Model for Dose Calculation to Circulating Blood and Lymphocytes, Published in final edited form as: Physics in Medicine & Biology. 2020 Mar 2;65(5):055008).
Regarding claims 1, 39, and 77, Ellsworth discloses a non-transitory, computer readable storage medium having instructions stored thereon that, when executed by a computer processor, cause the computer processor to receive medical imaging data from a subject including information about a treatment site receiving a dose of radiation and determine using the plurality of subject/treatment-specific variables as quantity of radiation received by circulating blood within the subject when receiving the dose of radiation (claim 1). Ellsworth further discloses methods for calculating the radiation doses received by circulating blood cells such as lymphocytes [0031]. Ellsworth further discloses generating a treatment plan [0036]; reading on limitations of a system for use in estimating the a post-treatment blood cell sub type count of lymphocytes of a subject treated via radiation therapy and for use in prospectively designing and optimizing radiation therapy treatment plans, wherein said system comprising: a computer processor; a memory configured to store instructions that are executable by said computer processor, wherein said computer processor is configured to execute the instructions for performing processing associated with importing subject data into a nonspherical simulation model;
Ellsworth further discloses that blood flows through the radiation treatment zone as radiation is delivered. In its simplest form, given (a] the length of treatment time (for each beam], (b] the flow rate of the blood through the site (for example, organ) and (c] the size of the treatment site, the amount of blood transiting through the irradiated zone may be calculated: specifically, as the voxel of blood flows through an irradiated voxel, the dose received is incremented by the dose delivered during the time it takes for the blood to transit through the voxel. [0043]. Ellsworth further discloses receiving medical imaging data from a subject including information about a treatment site receiving a dose of radiation and receiving a plurality of subject/treatment-specific variables including at least two of a target volume size associated with the dose of radiation, a radiation treatment technique associated with the dose of radiation, a dose rate associated with the dose of radiation, a total dose associated with the dose of radiation, a fraction size associated with the dose of radiation, a treatment time associated with delivering the dose of radiation, a speed of circulating blood within the subject, and a presence of vasculature relative to the treatment site (claim 1). Ellsworth further discloses that the processor may create a tumor volume with a specific shape (for example, nonspherical), e.g., spherical, calculate dose to the site, delineate the entire site and generate a three-dimensional dose grid for the site [0065]; reading on limitations of performing processing associated with determining from said subject data, at least one time-dependent dose for each voxel of at least one organ of said subject within said nonspherical simulation model.
Ellsworth further discloses modelling blood flow [0041]. Ellsworth further discloses a compartmental model which supplements the blood dose model to calculate dose distribution to the lymphocyte population [0044]; reading on limitations of performing processing associated with creating a blood flow model for said at least one organ of said subject within said simulation model.
Further regarding claims 1, 39, and 77, Ellsworth and Ellsworth 2019 do not expressly disclose that the blood flow model includes nonuniform blood velocities calculated from said subject data and organ-specific cardiac output. Hammi discloses developing a computational human body blood flow model (BFM), that enables to estimate the dose to the circulating blood during the course of fractionated radiation therapy to better understand how radiotherapy delivery parameters affect the depletion of circulating lymphocytes (abstract). Hammi further discloses developing a hemodynamic cardiovascular system based on human body reference values to distribute the cardiac output to 24 different organs, described by a discrete Markov Chain. Hammi further discloses extracting major cerebral vasculature from MRI data of a patient and complemented them with an extension network of generic vessels in the frontal and occipital lobes to guarantee even overall blood supply to the entire brain volume. Hammi further discloses that an explicit Monte Carlo simulation was implemented to track the propagation of each individual blood particle (BP) through the brain and time-dependent radiation fields, accumulating dose along their trajectories (abstract).
Ellsworth discloses simulating radiation dose delivery to the site using the tumor volume by using a software program [0037]. Ellsworth further discloses modeling the radiation dose delivered to circulating blood during a typical partial intracranial field in an effort to determine the role of radiation in the observed lymphopenia [0050]; reading on limitations of performing processing associated with simulating the delivery of a radiation dose to moving blood within said subject's body within said simulation model using said at least one time dependent dose for each voxel of said at least one organ of said subject and said blood flow model.
Ellsworth further discloses calculating the dose received by circulating blood during a course of external beam radiotherapy comprising the steps of obtaining medical imaging data of a site in a patient; creating a tumor volume within the site using the medical imaging data; determining a dose of radiation delivered to the site including the tumor volume and surrounding normal tissues; generating a three-dimensional dose grid for the site; using the three-dimensional dose grid for the site, calculating a distribution of radiation dose to a blood pool that is within or transits through the site [0009]; reading on limitations of performing processing associated with determining at least one absorbed dose value for said subject's lymphocytes within said nonspherical simulation model.
Ellsworth further discloses choosing specific dose of radiation based on in vitro data on lymphocyte radiosensitivity that showed a Dio (dose required to reduce the surviving lymphocyte (for example, calculating remaining lymphocyte count) population to 10% of initial values] of ~3 Gy, a D50 of ~2 Gy, and a D90 of ~0.5 Gy [0046].
Ellsworth further discloses a compartmental model which supplements the blood dose model to calculate dose distribution to the lymphocyte population including cells present in the blood initially as well as radiation treatment progresses which will be different from the generic blood volume dose distribution [0044].
Ellsworth further discloses determining a radiation treatment technique used to deliver the dose of radiation, a dose rate used to deliver the dose of radiation, a treatment time used to deliver the dose of radiation, a speed of circulating blood within the subject, and a of maj or vasculature proximate to at least one of the tumor volume and the site (claim 15).
Ellsworth further discloses a display to display a report of radiation doses received by circulating blood cells in a patient (claim 15), for example, transmitting dose related data to a secondary source.
Further regarding claim 1, Ellsworth does not expressly disclose calculating a remaining blood cell sub type count.
Ellsworth 2019 discloses a comprehensive analysis of the kinetics of radiation-induced lymphocyte loss in patients treated with radiotherapy. Ellsworth 2019 further discloses plotting the serial absolute lymphocyte count against radiotherapy fraction number and that during initial phase of fractionated radiotherapy, the lymphocyte depletion follows an exponential decay in the form ALC(x) = ae–bx, Where ALC is the absolute lymphocyte count after (x) fractions, a is initial lymphocyte count and b is the fractional lymphocyte loss rate (abstract). Ellsworth 2019 further discloses the relationship between radiation therapy parameters such as dose per fraction (absorbed dose delivered to tissue), mean organ dose (spatially absorbed dose), and the kinetics of lymphocyte loss and subsequently contributing to prediction of radiation-induced lymphopenia (abstract).
Regarding claims 2, 40, 78, Ellsworth discloses a display to display a report of radiation doses received by circulating blood cells in a patient (claim 15); reading on limitations of wherein said secondary source includes one or more of anyone of the following: local memory; remote memory; or display or graphical user interface.
Regarding claims 3, 41, 79, Ellsworth discloses a computer comprising a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data (claim 1 [0074]); reading on limitations of computer processor comprises at least one computer.
Regarding claims 5-6, 43-44, and 81-82, Ellsworth discloses a random-access memory (RAM] unit, and a read-only memory (ROM] unit [0061]; reading on limitations of memory further comprises a main memory and a static memory, electrically programmable read-only memory; electrically erasable programmable read-only memory; flash memory drive; magnetic disk; internal hard disk; external hard disk; removable disk; magneto-optical disk; CD-ROM disk; or DVD-ROM disk.
Regrading claims 7, 45, and 83, Ellsworth discloses radiation treatment planning [0027]; reading on limitations of radiation therapy treatment plans; molecular imaging planning image sets; dose maps; structure sets; delivery times of said radiation dose; blood cell sub type distribution pre-treatment rate of regeneration; pre-treatment rate of redistribution; or subject age.
Regarding claim 8, 46, and 84, Ellsworth discloses that suitable medical imaging data may include either one of magnetic resonance imaging (MRI] data or computed tomography (CT] data [0031]; reading on limitations of molecular imaging includes computed tomography (CT).
Regarding claim 9, 47, and 85, Ellsworth discloses a non-transitory, computer readable storage medium having instructions stored thereon that, when executed by a computer processor, cause the computer processor to determine radiation doses received by circulating blood within the subject when receiving the dose of radiation [0027-0030]; reading on limitations of nonspherical simulation model is controlled by said computer processor.
Regarding claim 10, 48, and 86, Ellsworth discloses that voxel is a three-dimensional shape within a three-dimensional matrix [0037].
Regarding claims 12, 50, and 88, Ellsworth discloses that the cellular component of interest, lymphocytes (for example, T cells, B cells, and/or natural killer cells) in the circulating blood with subtypes CD4+ and CD8+ [0046]; reading on limitations of cell sub type comprises lymphocytes, wherein said lymphocytes includes any one or more of the following sub types: CD3+; CD4+; CD8+; CD19+; or
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Regarding claims 13, 51, and 89 Ellsworth discloses quantifying a total volume of blood receiving radiation [0031], heart-to-heart circulation time, a treatment delivery time, a dose delivered to moving blood, [0043], and blood flow model [0041].
Regarding claim 14, 52, and 90, Ellsworth discloses that the term “subject" or "individual" refers to a human or other vertebrate animal, for example a child or an adult human or other vertebrate [0023]. Ellsworth further discloses quantifying a total volume of blood receiving radiation [0032]. Inherently disclosing a blood volume range of about 2 to about 7 liters; about 5 liters; or a range of about 4 to about 6 liters depending on the subject’s sex and age; reading on limitations of total blood volume is one of the following: a range of about 2 to about 7 liters; about 5 liters; or a range of about 4 to about 6 liters.
Regarding claims 15, 53, and 91, Ellsworth discloses that heart-to- heart blood circulation time is 30-s [0043]; reading on limitations of heart-to- heart blood circulation time is one of the following: a range of about 10 seconds to about 50 seconds; about 30 seconds; or a range of about 20 seconds to about 40 seconds.
Regarding claims 16, 54, and 92, Ellsworth discloses that dose rate, expressed in monitor units (MU]/min and the dose delivered per fraction by scaling the total number of monitor units delivered [0043] and that intensity modulated radiation therapy (IMRT] involves selecting the appropriate beam energy (photons, and perhaps protons], energy (for example, 6 MV, 18 MV] and arrangements [0028]. Ellsworth further discloses that subject/treatment-specific variables may include a target volume size associated with the dose of radiation, a radiation treatment technique associated with the dose of radiation, a dose rate associated with the dose of radiation, a total dose associated with the dose of radiation, a fraction size associated with the dose of radiation, a treatment time associated with delivering the dose of radiation, a speed of circulating blood within the subject [0030]; reading on limitations of treatment delivery time is determined by a total delivered machine units and a dose rate of energy used.
Regarding claim 17, 55, and 93, Ellsworth discloses that the dose may be extracted beam- by-beam for the plans other than IMRT and segment-by-segment for IMRT. Ellsworth further discloses using the dose to the brain during a normal course of radiation therapy (RT] as its input calculating the associated dose to blood circulating through this radiation field [0039-0040]. Ellsworth further discloses that given (a] the length of treatment time (for each beam], (b] the flow rate of the blood through the site and (c] the size of the treatment site, the amount of blood transiting through the irradiated zone may be calculated: specifically, as the voxel of blood flows through an irradiated voxel, the dose received is incremented by the dose delivered during the time it takes for the blood to transit through the voxel. Each blood voxel is followed or moved incrementally in the direction of blood flow specific to the anatomical region under treatment until the treatment time ends or the blood voxel exits the site [0043]; reading on limitations of dose delivered to moving blood is determined by: dividing a total beam time into time steps; applying said dose delivered to moving blood to a blood matrix; rotating said blood matrix; and randomly permuting blood.
Regarding claim 19, 57, and 95, Ellsworth discloses determining a radiation treatment technique used to deliver the dose of radiation, a dose rate used to deliver the dose of radiation, a treatment time used to deliver the dose of radiation, a speed of circulating blood within the subject, and a of major vasculature proximate to at least one of the tumor volume and the site (claim 14; [0030]); reading on limitations of blood velocities vary from a center to at least one wall of great vessels.
Regarding claims 29, 67, and 105, Ellsworth discloses cumulative dose calculation over time (for example, a time dependent dose) [0043]. Ellsworth further discloses identifying circulating blood as an organ at risk in radiation therapy by using the present method [0059]; reading on limitations of at least one time-dependent dose is organ specific.
In KSR Int 'l v. Teleflex, the Supreme Court, in rejecting the rigid application of the teaching, suggestion, and motivation test by the Federal Circuit, indicated that “The principles underlying [earlier] cases are instructive when the question is whether a patent claiming the combination of elements of prior art is obvious. When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR Int'l v. Teleflex lnc., 127 S. Ct. 1727, 1740 (2007).
Applying the KSR standard to Ellsworth and Ellsworth 2019, the examiner concludes that the combination of Ellsworth and Ellsworth 2019 represents applying a known techniques to a known method. Both Ellsworth and Ellsworth 2019 are directed to prediction of radiation-induced lymphopenia risk. Ellsworth only disclosed determining absorbed dose value from patient imaging data. In the same field of research, Ellsworth 2019 discloses estimating post-treatment lymphocyte count. Combining the absorbed dose value determination of Ellsworth with remaining lymphocyte count estimation of Ellsworth 2019 would have allowed for examining the relationship between absorbed radiation dose and lymphocyte depletion for the purpose of optimizing treatment planning. One ordinary skilled in the art before he effective filing data of the claimed invention would have had a reasonable expectation of success at combining the method of Ellsworth and Ellsworth 2019. This combination would have been expected to have provided a better prediction of lymphocyte counts post-treatment and potentially adjusting treatment to mitigate lymphopenia related risks. Therefore, the invention would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention, absent evidence to the contrary. Further, it would have been obvious to one ordinary skilled in the art before the effective filing the claimed invention to use the known Blood flow model of Hammi for nonuniform blood velocities as part of their analysis instead of bold flow model of Ellsworth that assumes evenly blood distribution to better understand how radiotherapy delivery parameters affect the depletion of circulating lymphocytes in patients treated for tumors. This substitution of one model to another would have provided better estimation of lymphocyte counts in radiation therapy patient improving their treatment plan. One ordinary skilled in the art could have substitutes the blood flow model of Ellsworth for blood flow model of Hammi and the results of the substitution would have been predictable.
Claims 4, 42, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Ellsworth et al. (WO2015116932A2) in view of Ellsworth et al. (Comprehensive Analysis of the Kinetics of Radiation-Induced Lymphocyte Loss in Patients Treated with External Beam Radiation Therapy, November 1, 2019, Radiation Research Society 193 (1): 73-81), hereinafter refer to as “Ellsworth 2019” and further in view of Hammi et al. (Four-dimensional Blood Flow Model for Dose Calculation to Circulating Blood and Lymphocytes, Published in final edited form as: Physics in Medicine & Biology. 2020 Mar 2;65(5):055008), as applied to claims 1-10, 12-17, 19, 29, 39-48, 50-57, 67, 77-86, 88-93, 95, and 105 above, further in view of Zhou et al. (US20190336793A1).
Claims 4, 42, and 80 depends on claims 1, 39, and 77. Limitations of claims 1, 39, and 77 are taught in the above rejections.
Regarding claim 4, Ellsworth discloses a computer processor having user interface, an application specific circuit, and the like. Ellsworth and Ellsworth 2019 do not expressly disclose that the system comprises a server coupled to a network.
Zhou discloses a method for generating a radiation treatment plan comprising determining a set of one or more optimization goals for radiation delivery (claim 1), where they capture images during or after radiation therapy [0043]. Zhou further discloses a processing device that may obtain, via the network, user instruction(s) for generating images, adjusting a treatment plan, delivering radiation according to a treatment plan, etc. where the network may be any type of wired or wireless network, or combination thereof. Zhou further discloses that the may be and/or include a public network (e.g., the Internet), a private network (e.g., a local area network (LAN), a wide area network (WAN)), etc.), a wired network (e.g., an Ethernet network), a wireless network (e.g., an 802.11 network, a Wi-Fi network), a cellular network (e.g., a Long Term Evolution (LTE) network), a frame relay network, a virtual private network (“VPN”), a satellite network, a telephone network, routers, hubs, switches, server computers, and/or any combination thereof; reading on limitations of system further comprises: a server coupled to a network; a user interface coupled to said network; and an application coupled to said server and/or said user interface, wherein the application is configured for executing said computer processor.
Applying the KSR standard to Ellsworth, Ellsworth 2019, and Zhou, the examiner concludes that the combination of Ellsworth, Ellsworth 2019, and Zhou represents applying a known techniques to a known method. Ellsworth, Ellsworth 2019, and Zhou are directed to radiation therapy treatment planning. Ellsworth and Ellsworth 2019 only disclosed determining absorbed dose value from patient imaging data and estimating post-treatment lymphocyte count. In the same field of research, Zhou discloses using a sever coupled to a network for executing instructions. Combining the absorbed dose value determination of and remaining lymphocyte count estimation of Ellsworth and Ellsworth 2019 with a server coupled to a network of Zhou would have allowed for providing data and resources to other computers on a network for examining the relationship between absorbed radiation dose and lymphocyte depletion. One ordinary skilled in the art before he effective filing data of the claimed invention would have had a reasonable expectation of success at combining the method of Ellsworth, Ellsworth 2019, and Zhou. This combination would have been expected to have provided a better prediction of lymphocyte counts post-treatment enhancing performance, scalability, and reliability. Therefore, the invention would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention, absent evidence to the contrary.
Claims 20-25, 58-63, and 96-101 are rejected under 35 U.S.C. 103 as being unpatentable over Ellsworth et al. (WO2015116932A2) in view of Ellsworth et al. (Comprehensive Analysis of the Kinetics of Radiation-Induced Lymphocyte Loss in Patients Treated with External Beam Radiation Therapy, November 1, 2019, Radiation Research Society 193 (1): 73-81), hereinafter refer to as “Ellsworth 2019” and further in view of Hammi et al. (Four-dimensional Blood Flow Model for Dose Calculation to Circulating Blood and Lymphocytes, Published in final edited form as: Physics in Medicine & Biology. 2020 Mar 2;65(5):055008), as applied to claims 1-10, 12-17, 19, 29, 39-48, 50-57, 67, 77-86, 88-93, 95, and 105 above, further in view of Pinter (Dynamic Representation of Anatomical Structures in Radiation Therapy Treatment Planning, Queen’s University Kingston, Ontario, Canada July, 2019, pages 1-112).
Claims 20-25, 58-63, and 96-101depends on claims 1, 39, and 77. Limitations of claims 1, 39, and 77 are taught in the above rejections.
Regarding claims 20-25, 58-63, and 96-101, Ellsworth discloses a compartmental model which supplements the blood dose model to calculate dose distribution to the lymphocyte population [0044].
Further regarding claims 20-25, 58-63, and 96-101, Ellsworth and Ellsworth 2019 do not expressly disclose that the blood flow model comprises at least one logical mask, at least one dose map, at least one structure set, and at least one blood matrix.
Pinter discloses a radiation therapy treatment planning analysis. Pinar further discloses that for radiation therapy, the first generation of the DICOM standard requires the structures to be stored as “structure sets” – a series of planar contours (Figure 1/D). Structure sets may also be represented as ribbons (Figure 1/E), which is an efficient way to display planar contours in 3D.
Pinar further discloses segmenting targets to treat and organs to avoid by delineating their cross-section in multiple slices of the image, which results in a list of planar contours. Contours are then voxelized into labelmaps (for example, masks), so that they can be used as masks for selecting voxels of dose distribution volumes (for example, dose map) (g. 3, last para., pg. 4, first para.). Pinar further discloses optimizing spatial distribution of delivered dose (for example, blood matrix) and addressing spatial distribution by segmentation (pg. 2, last para.).
Pinar further discloses 2D/3D visualization and bulk transformation of segmentations (for example, matrix shift) using PolySeg for dynamic representation management (pg. 78, first para.; figure 21) which allows assigning a directions matrix in addition to the origin and spacing geometry properties (pg. 29, last para.).
Applying the KSR standard to Ellsworth, Ellsworth 2019, and Pinar, the examiner concludes that the combination of Ellsworth, Ellsworth 2019, and Pinar represents applying a known techniques to a known method. Ellsworth, Ellsworth 2019, and Pinar are directed to radiation therapy treatment planning. Ellsworth and Ellsworth 2019 only disclosed determining blood flow model and absorbed dose value from patient imaging data and estimating post-treatment lymphocyte count. In the same field of research, Pinar discloses details of blood flow model, such as a mask, dose map, structure set, and matrix. Combining the absorbed dose value determination of and remaining lymphocyte count estimation of Ellsworth and Ellsworth 2019 with blood flow model details of Pinar would have allowed for better estimation of blood and immune cell circulation through irradiating regions. One ordinary skilled in the art before he effective filing data of the claimed invention would have had a reasonable expectation of success at combining the method of Ellsworth, Ellsworth 2019, and Pinar. This combination would have been expected to have provided a better prediction of lymphocyte counts and radiation-induced immune suppression. Therefore, the invention would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention, absent evidence to the contrary.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive. Applicant states:
While in disagreement with the present rejection, in an effort solely to advance prosecution and to emphasize distinction over the prior art, Applicant has amended the independent claims. For instance, independent claim 1 now recites, in part, "performing processing associated with determining at least one absorbed dose value for said subject's lymphocytes within said nonspherical simulation model,""performing processing associated with creating a blood flow model, including nonuniform blood velocities calculated from said subject data and organ-specific cardiac output," and "performing processing associated with determining at least one absorbed dose value for said subject's lymphocytes within said nonspherical simulation model." Support for this amendment, and similar if not identical amendments for claims 39 and 77, may be found throughout the Applicant's application.
It is respectfully submitted that the above statements are not persuasive. The amendment to claims necessitated a new round of art rejection. As stated above, the combination of Ellsworth, Ellsworth 2019 and Hammi read on all limitations of claims 1, 39, and 77.
Applicant further states:
the amended limitation of claims 1, 39, and 77 of "performing processing associated with determining at least one absorbed dose value for said subject's lymphocytes." The relevant Ellsworth method cited by the Examiner only calculates the dose received by blood in general, which does not correspond to the limitation that specifically calculates the absorbed dose value for lymphocytes, which make up only a fraction of the total composition of blood.
It is respectfully submitted that the above statements are not persuasive. Ellsworth discloses calculating a dose of radiation to a blood pool within or transiting through the site defining a radiation dose distribution to the blood volume considered as a whole [0010]. Ellsworth further discloses that the dose tally for each blood voxel, i, is the sum of doses received in the different physical voxels j through which the blood transited: wherein dDj/dt is the dose rate in voxel j and tj is the time the blood took to transit through voxel j with beam on. For each beam, the process is repeated, but the total blood voxel dose from each beam or each fraction is convolved with the dose distribution obtained from previous beams or fractions, thereby confirming that the received dose is the absorbed dose.
Applicant further states:
The Office Action also states that "[the] Ellsworth [patent]... discloses that as the voxel of blood flows through an irradiated voxel, the dose received is incremented by the dose delivered," (Office Action, pg. 12). The relevant paragraph cited in the Ellsworth patent similarly states that "as the voxel of blood flows through an irradiated voxel, the dose received is incremented by the dose delivered during the time it takes for the blood to transit through the voxel." [0043]. Though the Examiner asserts this disclosure reads upon the determination of the dose for each "voxel of at least one organ," Applicant respectfully submits that the "voxel of blood" of the Ellsworth patent is not the same as "voxel of at least one organ," as currently recited by the claimed invention, as blood is not an organ.
It is respectfully submitted that the above statement is not persuasive. Ellsworth in the same paragraph [0043] discloses that each blood voxel is followed or moved incrementally in the direction of blood flow specific to the anatomical region under treatment (for example, organ) until the treatment time ends or the blood voxel exits the site.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/G.S./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686