Prosecution Insights
Last updated: May 29, 2026
Application No. 17/399,704

SYSTEMS AND METHODS FOR PATIENT-SPECIFIC IMAGING AND MODELING OF DRUG DELIVERY

Non-Final OA §101§112§DOUBLEPATENT§DP
Filed
Aug 11, 2021
Priority
Sep 16, 2015 — provisional 62/219,490 +1 more
Examiner
CLOW, LORI A
Art Unit
1687
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Heartflow Inc.
OA Round
3 (Non-Final)
64%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
93%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
452 granted / 707 resolved
+3.9% vs TC avg
Strong +29% interview lift
Without
With
+28.7%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
23 currently pending
Career history
736
Total Applications
across all art units

Statute-Specific Performance

§101
13.2%
-26.8% vs TC avg
§103
48.0%
+8.0% vs TC avg
§102
12.8%
-27.2% vs TC avg
§112
9.4%
-30.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 707 resolved cases

Office Action

§101 §112 §DOUBLEPATENT §DP
DETAILED ACTION A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on filed 14 April 2026 has been entered. Applicant's response has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. 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 21-40 are currently pending and under exam herein. Claims 1-20 have been cancelled. Specification Note: All references to the Specification herein pertain to the PG publication: US20210375401. Claim Interpretation Claims 21, 35, and 38 have been amended to recite, “applying a trained machine learning system to the feature vectors to estimate the drug delivery data at the one or more locations where the drug is to be delivered target tissue model information, a plurality of data on target tissue locations, and a plurality of patient-specific data, ”, whereby the recitation “the trained machine learning system having been trained to estimate the drug delivery data…” is interpretated as not limiting to the instant claims to any active “training” step. As such, the “machine learning system” herein is any system that provides machine learning capabilities. Claim Rejections - 35 USC § 112(b)-Indefiniteness 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. Claims 21, 35, and 38, as amended, recite, “applying a trained machine learning system to the feature vectors to estimate the drug delivery data at the one or more locations where the drug is to be delivered of the patient-specific model, the trained machine learning system having been trained to estimate the drug delivery data based on a plurality of drug administration information, a plurality of data on target tissue locations, a plurality of patient-specific data, and a plurality of patient specific data”, wherein the claim, as amended, is still indefinite with respect to the estimation of drug delivery using an undefined trained machine learning system because the “feature vectors” are not clearly recited such that one is apprised of what information regarding drug delivery, location and patient-specific data are utilized such that there is a meaningful limit to the vectors themselves, whereby “estimation” of drug delivery to a model in locations on the target tissue could be determined. Clarification through clearer claim language is requested. Claims 21, 35, and 38 recite, “applying a trained machine learning system to the feature vectors to estimate the drug delivery data at the one or more locations wherein the drug is to be delivered of the patient-specific model”, wherein as amended the claim fails to make sense with respect to “wherein the drug is to be delivered of the patient-specific model”. It would appear as if this could be a typographical error but, as claimed it is unclear as to the meaning of a “drug delivered of the patient-specific model”. For examination purposes the claim is interpreted as a step whereby the ML system is applied to the feature vectors to estimate drug delivery data at the one or more locations where the drug is to be delivered to (or in) the patient specific model or the like. Clarification through clearer claim language is requested. 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 21-40 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the framework as outlined in the MPEP at 2106.04: Framework with which to Evaluate Subject Matter Eligibility: (1) Are the claims directed to a process, machine, manufacture or composition of matter; (2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea; Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and (2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept. Framework Analysis as Pertains to the Instant Claims: Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter With respect to step (1): yes, the claims are directed to a method, system and non-transitory computer readable medium of estimating drug delivery at a target tissue. Step 2A, Prong 1 Analysis: Do claims recite abstract idea With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as: mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations); certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information). With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information). The claim steps to abstract ideas are as follows: Claims 21, 35, and 38: -determining on or more feature vectors comprising on drug administration information, one or more locations where the drug is to be delivered, and the patient-specific data wherein steps directed to “determining” are those that are directed to mental operations using vector mathematics and observing data to form from it, vectors. As such, the step is abstract. -applying a trained machine learning system to the feature vectors to estimate the drug delivery data at the one or more locations wherein the drug is to be delivered of the patient-specific model of the patient… wherein a step directed to applying a machine learning model to estimate is interpreted herein under the Broadest Reasonable Interpretation (BRI) of the claim as a mental step of “estimating” using given data wherein the machine learning herein is merely a tool by which to perform said abstract step. There are no specifics as to the machine learning other than “using” it to perform estimations and therefore said step is abstract, as machine learning is generically recited. “Training” is not actually performed in the claim, as recited rather, the training has been performed previous to the claim. See, as example, claim 24 directed to numerous types of machine learning. As such, said steps are abstract. Dependent claims herein are further directed to steps of training a system that include using various ML operations (claim 24); “developing a patient-specific fluid dynamics model”, wherein computational fluid dynamics models are performed by mathematical operations; “calculating a transportation, spatial and/or temporal distribution…” whereby said distribution calculations are mathematical; (claims 25, 37 and 4), wherein said models are mathematical in nature; “assessing effectiveness…by comparing one or more actual drug delivery data” (claim 30, wherein said step is, under plan meaning, one that is mental by way of comparing one data to another. Further dependent claims have been assessed herein and further limit the recited judicial exception operations as in the independent claims herein. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper). There are no specifics as to the methodology involved in “determining” or in “estimating” and thus, under the BRI, one could simply, for example, perform said operations with the aid of a generic computer as a tool to perform said functions. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts. Further, see MPEP § 2106.04(a)(2), subsection III. 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 slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). Step 2A, Prong 2 Analysis: Integration to a Practical Application Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III). With respect to the instant recitations, the claims recite the following additional elements: Claims 21, 35 and 38: determining or receiving a patient-specific target-tissue model, where a drug is to be delivered, determining or receiving a patient-specific vascular model modeling a blood supply to the target tissue of a patient; deriving patient-specific data from the patient-specific target tissue model, wherein each of the steps recited above directed to “determining” and “receiving” and “deriving” are those that are directed to data gathering in the instant claims by way of getting models and drug administration information and patient data. Steps in claims 35 and 38 additionally recited those additional elements such as a “system”; “processor”; computer-readable medium”. Steps in the dependent claims have also been analyzed and serve as additional operations that merely provide for data collection in the instant claims or the provision of data in the claims as provided by way of operating said judicial exceptions. As such, the dependent claims 22-24, 36-37, and 39-40 further limit said operations. Further with respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g). Further steps herein directed to additional non-abstract elements of “processor; computer; storage medium etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)). Step 2B Analysis: Do Claims Provide an Inventive Concept The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi). With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s). With respect to the instant claims, said claims directed to data gathering elements are routine, well-understood and conventional wherein the data gathering steps constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)). The steps directed to data gathering herein by getting patient models is taught in the prior art at least at 8,315,812. Further art to 20090210209 disclose getting pharmacological patient data. As such, said operations were well-established in the art. With respect to claims 21-40, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. But rather, the additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III). The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception. For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter. Response to Applicant’s Arguments 1. Applicant points to Example 39, as well as the Office Memorandum pertaining to AI as published 4 August 2025, stating that "[c]laim limitations that encompass AI in a way that cannot be practically performed in the human mind do not fall within" the mental processes grouping. Memorandum, p. 2. For example, the "claim limitation 'training the neural network in a first stage using the first training set' of [published USPTO] example 39 does not recite a judicial exception. Even though 'training the neural network' involves a broad array of techniques and/or activities that may involve or rely upon mathematical concepts, the limitation does not set forth or describe any mathematical relationships, calculations, formulas, or equations using words or mathematical symbols." Id., p. 3 (citing published USPTO Example 39)”. Applicant states that “as applied to the present case, at least the "applying a trained machine learning system to the feature vectors to estimate the drug delivery data at the one or more locations where the drug is to be delivered of the patient-specific target tissue model" clause of amended claim 21 similarly encompasses AI in a way that cannot be practically performed in the human mind, and does not set forth or describe any mathematical relationships, calculations, formulas, or equations using words or mathematical symbols. As such, amended claim 21 does not recite a judicial exception” and further including that steps are directed to those that result in an improvement to the technology for drug delivery evaluation, which integrate the subject matter of amended claim 21 into a practical application, pointing to eh Specification at [0005] and [0036]. Applicant includes that “conventional methods of drug delivery evaluation are often inaccurate and ineffective as they often fail to account for inter-patient variation or require excessive amounts of compute to estimate. By at least "determining one or more feature vectors comprising (i) drug administration information, (ii) the data indicating the one or more locations where the drug is to be delivered, and (iii) the patient-specific data," where the "patient-specific data [is derived] from the patient- specific target tissue model and/or the patient-specific vascular model," inter-patient variation may be accounted for. Further, by utilizing the feature vectors as inputs for the trained machine learning system-as opposed to direct analysis of the patient-specific target tissue model and/or the patient-specific vascular model by the trained machine learning system-the amount of compute required by the trained machine learning "to estimate the drug delivery data at the one or more locations where the drug is to be delivered of the patient-specific target tissue model" may be significantly reduced. As such, the combination of elements recite a specific improvement to the technology for drug delivery evaluation by incorporating patient-specific models and data, and reducing required compute”. It is respectfully submitted that this is not persuasive. With respect to the Memorandum of 4 August 2025 and Example 39, Applicant will note that the exemplary claim from Example 39 is directed to “training the neural network in a first stage using the first training set” wherein the claim step is directed to actual “training”. The same is not the case with the instant claims that merely apply a trained system to “estimate” wherein the system itself is generically recited and not actively trained to do anything except perform the abstract step of “estimate”. As such, the system is a tool by which to perform the judicial exception of estimation and is therefore an additional element that is not significantly more in the claim. It is suggested that the step of actual “training” using specific parameters by which to do so be claimed if Applicant is relying on the analogy to Example 39. Even if said “training” were to be claimed, Applicant is advised that the training must lend itself to more than just applying a machine learning system to solve a known problem (i.e., provide evidence to improvement in technology, for example). Applicant currently states that the specification indicates that this provides a personalized approach by monitoring drug levels in blood plasma and adjusting dose so as to minimize toxicity and improve chemotherapy outcomes. However, no such steps directed to active drug level monitoring of a patient, for example are recited in a manner such that the integration of said technology using machine learning to calculate estimates is applied. Applicant is also reminded herein that the steps directed to “determining feature vectors” and “applying machine learning system…to estimate” are steps that are themselves the judicially recited exceptions herein. As such, said steps cannot represent the steps that provide for either integrate or inventive concept on their own. Rather, it is the additional elements that would provide for said integration of those steps that would provide for such, if, in fact there were additional elements that could meet said criteria. However, as pointed to above, there are no steps meeting said threshold. The step of “outputting” herein is merely one directed to outputting the result of the performed judicial exceptions without significantly more. As such, the claims remain non-eligible. Double Patenting 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 1. Claims 21-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,120,893. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘893 patent are directed to subject matter that includes: receiving a patient-specific anatomical model of at least one vessel of the patient and a target tissue where a drug is to be supplied; receiving patient-specific information defining administration of a drug to the patient; identifying one or more locations in the target tissue where drug delivery data will be computed; deriving patient-specific data from the patient-specific anatomical model and/or the patient, the patient-specific data including one or more physiological conditions; determining, by measuring or calculating, one or more personalized blood flow characteristics in a vascular network leading to the one or more locations in the target tissue where drug delivery data will be computed, using the patient-specific anatomical model, patient-specific information defining the administration of the drug and the patient-specific data including the one or more physiological conditions; simulating drug delivery by virtually modeling the administration of drug particles into the vascular network of the patient-specific anatomical model upstream from the one or more locations in the target tissue; calculating a transportation, spatial, and/or temporal distribution of the drug particles in one or more locations of the vascular network using size and amount of the drug particles, one or more equations describing drug transport, the patient-specific information defining the administration of the drug including size and amount of the drug particles, and calculated one or more personalized blood flow characteristics, wherein the amount of the drug particles are calculated based on a prescribed dosage of the drug; determining a ratio of the drug particles reaching the target tissue to the drug particles administered in total based on the calculating the distribution of the drug particles to the one or more locations of the vascular network and the calculated one or more personalized blood flow characteristics; computing personalized drug delivery data at the one or more locations in the target tissue of the patient-specific anatomical model using the patient-specific data derived from the patient-specific anatomical model and the transportation, spatial, and/or temporal distribution of the drug particles, the personalized drug delivery data including a circulatory destination probability of the drug particles administered into the vascular network leading to the target tissue based on the ratio of the drug particles reaching the target tissue to the drug particles administered in total; outputting the personalized drug delivery data in three-dimensional display overlaid on the patient-specific anatomical model to an electronic storage medium and/or display medium; and modifying drug administration to cause the computed personalized drug delivery data including the ratio of the drug particles reaching the target tissue to the drug particles administered in total in the target tissue to be within a range of desired drug delivery data in the target tissue, which overlaps in scope with the subject matter claimed herein in instant claims 21, 22, 35, 36 and 38-39 directed to: receiving a patient-specific model of the target tissue where a drug is delivered, and of a vascular network supplying blood to the target tissue of the patient; receiving information on drug administration of the patient; receiving data on one or more locations of the target tissue of the patient where the drug delivery data will be estimated or measured; determining feature vectors comprising information on drug administration, the data on one or more locations, and patient-specific data; applying a training machine learning system to the feature vectors to estimate the drug delivery data at one or more locations on the target tissue of the patient-specific model of the patient the trained machine learning system having been trained to estimate…. The claims to the ‘893 patent do not include the machine learning applications that include “vectorized data” or using machine learning as instantly claimed. However, it would have been obvious to one of skill in the art to have included machine learning in drug particle delivery in combination with ‘893 as taught in the prior art to, for example, Ding et al. (Briefings in Bioinformatics (2014) Vol. 15:734-747). Ding et al. disclose machine-learning techniques for computational predictions in drug-target interactions for drug target candidates (abstract). Response to Applicant’s Arguments 1. Applicant requests reconsideration of these double patenting rejections, or alternatively that these double patenting rejections be held in abeyance until the claims are otherwise in condition for allowance. It is noted that this is not persuasive as double patenting rejections may not be held in abeyance. As such, the rejections are maintained. Conclusion No claims are allowed. Inquiries Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. /Lori A. Clow/Primary Examiner, Art Unit 1687
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Prosecution Timeline

Aug 11, 2021
Application Filed
Jun 18, 2025
Non-Final Rejection mailed — §101, §112, §DOUBLEPATENT
Sep 18, 2025
Response Filed
Nov 21, 2025
Final Rejection mailed — §101, §112, §DOUBLEPATENT
Feb 23, 2026
Response after Non-Final Action
Apr 14, 2026
Request for Continued Examination
Apr 18, 2026
Response after Non-Final Action
May 06, 2026
Non-Final Rejection mailed — §101, §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
64%
Grant Probability
93%
With Interview (+28.7%)
4y 2m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 707 resolved cases by this examiner. Grant probability derived from career allowance rate.

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