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. Election/Restrictions Applicant’s election without traverse of Species A1 (claims 6-7) in the reply filed on 02/18/2026 is acknowledged. Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/18/2026. During a telephone conversation with Robert Smyth on 03/24/2026 a provisional election was made without traverse to prosecute the invention of Species B1 , claim 10-11. Affirmation of this election must be made by applicant in replying to this Office action. Claim 12 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim Status Claims 1-19 are pending. Claims 8-9 and 12 are withdrawn pursuant to a restriction requirement. Claims 1-7, 10-11 and 13-19 are under examination herein. Claims 1-3, 13 and 18-19 are objected to . Claims 1-7, 10-11 and 13-19 are rejected. Priority The instant application is the National Stage entry of PCT/ EP2020 /065831 , International Filing Date: 06/08/2020 and also claims foreign priority to EP19305734.6 , filed 06/06/2019 . As such, the effective filing date assigned to each of claims 1-7, 10-11 and 13-19 is 06/06/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The Information Disclosure Statement filed 12/02/2021 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “3.7”. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “3.” (fig 2). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The abstract of the disclosure is objected to because it uses phrases which can be implied ( e.g. “The invention concerns…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Claim Objections Claim s 1 -3 , 13 and 18-19 are objected to because of the following informalities: I n claims 1 and 13, there is i mproper indentation . W here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation . See MPEP 608.01(m). In claim 1, a cronyms are used without stating its spelled-out term or name (e.g. “Crap”, “CE”, “ CEmax ”, “ CEcut ”). For clarity, it is recommended to introduce an acronym by placing the acronym in parentheses after the first use of the spelled-out term or name . In claims 1-2 and 13, b oth reference characters and acronyms/abbreviations are in parentheses and cause confusion. For clarity, r eference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). In claims 2-3 and 13, “comprising” should be “ further comprising” In claims 18-19, “ programme ” should be “program”. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 1-7, 10-11 and 13-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 , and all claims dependent thereon, recites the limitation " the possible target(s) " in line 20 . There is insufficient antecedent basis for this limitation in the claim , as the claim does not previously recite possible target(s) . Furthermore, the metes and bounds of the configuration of the Bayesian model in claim 1 is rendered indefinite by the lack of a conjunction between the respective sub-steps. For the purposes of examination, the conjunction is interpreted to be “and/or”. Claim 5 , and all claims dependent thereon, recites the limitation “the product of a target ratio (RC) and a susceptibility factor (SUS) relative to said bacteria ” in lines 2-3, and “the ratio” and “the drug efficiency” in line 4. There is insufficient antecedent basis for this limitation in the claim, as the claims do not previously recite a product of a target ratio (RC) and a susceptibility factor (SUS) relative to said bacteria , ratio or a drug efficiency. Claim 7, and all claims dependent thereon, recites the limitation “ the product of the target ratio (RC) for the identified antibiotic and the susceptibility factor (SUS) ” in line 5. There is insufficient antecedent basis for this limitation in the claim, as the claims do not previously recite a product of the target ratio (RC) for the identified antibiotic and the susceptibility factor (SUS) . Claim 14, and all claims dependent thereon, recites the limitation “ t he dose and/or the dose interval for time and concentration-dependent antibiotics, or the dose, the dose interval and/or the duration of infusion for time dependent antibiotics ” in lines 2 -4 . There is insufficient antecedent basis for this limitation in the claim, as the claims do not previously recite a dose, dose interval or duration of infusion for any antibiotics (concentration- or time-dependent) . For the purpose of interpretation, antibiotic is interpreted as the drug. Claim 18, and all claims dependent thereon, recites the limitation “ the computer programme ” in line 1. There is insufficient antecedent basis for this limitation in the claim, as the claims do not previously recite a computer programme . 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 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim s are directed to software or a signal per se . Claims 1-7, 10-11 and 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter ( Step 1: YES ) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A , Prong 1). Although claims 18-19 are directed to non-statutory subject matter , they have been included in the analysis for the purposes of compact prosecution. For example, i n the instant application, the claims recite the following limitations that equate to an abstract idea: Claim 1 recites obtaining patient-related data related to said patient (2); - obtaining a concentration of said drug measured in the patient's body at an arbitrary time (Cm(t)) ; from said measured concentration (Cm(t)), computing ( E1 ) an estimated drug concentration ( C3 ) time-course by using a Bayesian model configured according to :" an initial dose previously administered to the patient;" mean values of parameters selected from said patient-related data " interindividual variability of said parameters amongst a population of patients; said method being characterized in that it further comprises: - from said estimated drug concentration time-course ( C3 ), determining an efficiency pharmacokinetic parameter (PPE) adapted to said drug and to said patient and a residual drug concentration (Cr); - determining possible targets including at least one possible target (Crap, CE) for the efficiency pharmacokinetic parameter (PPE) and one possible target for the residual drug concentration (Cr), defined as the residual drug concentration for which an increased risk of side effects is reported and called increased risk target ( Clim );- a first comparison step ( S1 ) wherein said efficiency pharmacokinetic parameter (PPE) is compared to at least one of the possible target(s) (Crap, CE, CEmax , CEcut ) for the efficiency pharmacokinetic parameter (PPE); - a second comparison step ( S2 ) wherein the residual drug concentration (Cr) is compared to a toxic concentration ( C t ox ) defined as a drug concentration beyond which serious side effects occur and wherein the residual drug concentration (Cr) is compared to the increased risk target ( Clim );- selecting at least one of the possible targets according to the first and second comparison steps S1,S2 ); - for each selected target, determining ( E13 ) said optimum drug dosing regimen to treat said patient to reach said selected target. These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, obtaining data, determining PPE, determining possible targets, performing comparison steps, selecting targets and determining an optimum drug dosing routine to reach the selected target can be practically performing the human mind as claimed, since the mind can read data , determine/select targets, make comparisons and determine a dosing regimen as claimed , and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC , 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps of computing an estimated drug concentration ( C3 ) time-course by using a Bayesian mode and determining PPE equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc. , 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations fall under the “mathematical concepts” grouping of abstract ideas. Claims 2-7, 10-11 and 13-19 also recite judicial exceptions or f urther qualify the judicial exceptions. As such, claims 1-7, 10-11 and 13-19 recite an abstract idea ( Step 2A , Prong 1: YES ). Claims found to recite a judicial exception under Step 2A , Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A , Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Rather, the instant claims recite additional elements that amount to mere data gathering and outputting and mere instructions to implement the abstract idea in a generic computing environment. Specifically, the claims recite the following additional elements : Claim 6 recites receiving bacteria data identifying the bacteria . Claim 7 recites displaying a value of a percentage of sensitive strains of the identified bacteria which can be annihilated by the measured drug concentration if, according to the first comparison step ( S1 ), the efficiency pharmacokinetic parameter (PPE) is strictly less than the possible target (CE) defined as the product of the target ratio (RC) for the identified antibiotic and the susceptibility factor (SUS) being the epidemiological cut-off value ( ECOFF ) of the identified bacteria. Claim 15 recites an application server and a client terminal . Claim 16 recites a patient database (5) from which the client terminal (3) and/or the application server (4) is adapted to retrieve patient-related data. Claim 17 recites a third- party database (6) from which the client terminal (3) and/or the application server (4) is adapted to retrieve information on pathogenic agents and/or information on drug interactions. Claim 18 recites a computer programme and a computer Claim 19 recites a medium for storing information, removable or not, readable by a computer (3) or a microprocessor (3.1) and comprising code instructions of a computer programme adapted for implementing the steps of the method according to claim 1, when said programme is executed by a computer. Claim 6 recites further limitations of how data is obtained. These limitations equate to mere data gathering activity to obtain the data necessary for the mental evaluations and judgements (see MPEP 2106.05(g)). It is noted that c laims 7 recites contingent limitations, which are not required to be performed. However, even if it were required, claim 7 recites limitations for outputting data that the courts consider to be an insignificant extra-solution activity (see MPEP 2106.05(d)). Claims 15-19 merely recites using a generic computing systems and computer program products to carry out instructions to implement an abstract idea on a computer. The computer system and computer program product as claimed fails to recite details of how a solution to a problem is accomplished and only recites the idea of a solution or outcome. There are no limitations that indicate that the claimed steps require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp. , 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Furthermore, 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 Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1-7, 10-11 and 13-19 are directed to an abstract idea ( Step 2A , Prong 2: NO ). Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself ( Step 2B ). Further analyzing the additional elements under step 2B , the additional elements as described above do not rise to the level of significantly more than the judicial exception. As 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 under the 2B analysis, the instant specification discloses there are third-party databases with information related to pathogenic agents (p 9, ln 11-16) . As such, activities such as data gathering and outputting do not provide a non-conventional or unconventional step. Rather, the data gathering and outputting steps as recited in the instant claims 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)). Furthermore, 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); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself ( Step 2B : NO ). As such, claims 1-7, 10-11 and 13-19 are not patent eligible under 35 U.S.C. 101. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim s 1-3, and 13-19 are rejected under 35 U.S.C. 102 (1) as being anticipated by Hirt et al. ( Antimicrobial agents and chemotherapy 2006 , 50(6), 2079-2086 ; hereafter referred to as Hirt). With respect to claim 1, and 15-19, Hirt discloses developing a population pharmacokinetic model in order to describe the concentration time course of nelfinavir and its metabolite M8 in pregnant and nonpregnant women and determining a dosage regimen (abstract). Hirt discloses obtaining patient data and plasma concentration of the drug (p 2080, col 1, para 1-2). Hirt discloses estimating drug concentration using Bayesian pharmacokinetic estimates configured to m ean data set mean for parameters and the corresponding intersubject percent variabilities (abstract; Table 3; p 2082, col 1, para 3-p 2083, col 2, para 4). Hirt discloses a significant relationship has already been demonstrated between nelfinavir antiretroviral efficacy/safety and minimum plasma concentration , and discloses Nelfinavir concentrations versus time were fitted using the NONMEM subroutine (i.e. PPE) (p 2079, col 2, para 2). Hirt discloses f or evaluation of the goodness of fit, the following graphs were compared: observed and predicted concentrations versus time, observed concentrations versus predictions, weighted residuals versus time, and weighted residuals versus predictions, as well as the corresponding graphs issued from the POSTHOC estimation step (p 2080, col 2, para 3). Hirt discloses comparing residual drug concentrations to the recommended and increased dosage , and taking into consideration drug exposure of the infant and increased gastrointestinal intolerability issues which could complicate deliver y , and determining optimum dosing regimen , suggesting drug concentrations should be compared to toxic concentrations that can cause serious side effects (p 2082, col 2, para 4 - p2083 , col 2, para 2 ; p 2085, col 1, para 4 ) . Hirt further discloses the method is computer implemented and using databases (p 2080, col 1, para 2-col 2, para 3; p 2081, col 2, para 1). With respect to claim s 2 -3 , Hirt discloses obtaining drug data and comparing efficient target to reported concentrations (p 2082, col 2, para 4- p2083 , col 2, para 2). With respect to claim 13, Hirt discloses delivering double the dose for pregnant women, but in 3 administrations (fig 6; p2083 , col 2, para 2). With respect to claim 14, Hirt discloses modifying the dose and dose intervals for the concentration dependent drug (fig 3-6). 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. Claim 4-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hirt et al. ( Antimicrobial agents and chemotherapy 2006 , 50(6), 2079-2086 ; hereafter referred to as Hirt) as applied to claim s 1-3 above, and further in view of Sy and Derendorf ( In Clinical pharmacology: current topics and case studies 2016, (pp. 185-217). Cham: Springer International Publishing ; hereafter referred to as Sy) . With respect to claims 4-7, and 10-11, Hirt discloses the limitations of claims 1-3, as applied above. However, Hirt does not disclose that the drug is an antibiotic. However, the prior art to Sy, in the same field of endeavor, discloses e stablishing pharmacokinetic-pharmacodynamic (PK-PD) relationship of a new drug candidate is very crucial for the drug development process and that t he therapeutic efficacy of antibiotics is very dependent not only on the drug itself but also on whether there is enough drug concentration at the site of infection for a sufficient amount of time that would stop the development of bacterial resistance and on the susceptibility and severity of the infection (p 185, para 1- 186, para 2). With respect to claim 4, Sy discloses t he bacterial pathogen is the target site of action for antibiotics (section 13.1.1). With respect to claims 5- 6 , Sy discloses p harmacokinetic- pharmacodynamic indices as targets for achieving antimicrobial efficacy and models to c haracterize the antimicrobial activity of the drug , such as peak concentration/MIC, (fig 13.1-13.2; section 13.1.1-13.1.3) With respect to claim 7, Sy discloses that t he microorganisms with MIC value that result in PD index with values lower than the target are categorized as resistant, whereas those with values higher than target are susceptible (abstract; p 190, para 3). With respect to claim 10-11, Sy discloses i f the relationship is time dependent as characterized by fT > MIC, the strategy is to maintain the free drug concentrations above the MIC for an extended period of time , such as the target PD index for ceftazidime is to maintain its concentration above MIC for 60 % of the dosing interval , and further that the time-course-based approach can be developed from time-kill kinetic studies that trace the time-course of bacterial response to both constant and dynamic drug concentrations (p 187, para 1-p 190, para 2; fig 13.1-13.3) Sy further discloses e ven with all these advancements, there are still areas of potential improvements as many antimicrobials are still poorly characterized s pecial populations (p 209, para 3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modeling the pregnancy related effects on the pharmacokinetics of Nelfinavir- M8 of Hirt, to also model the effects of pregnancies on the pharmacokinetics of antibiotics, as disclosed by Sy, as e ven with all these advancements, there are still areas of potential improvements as many antimicrobials are still poorly characterized s pecial populations and e stablishing pharmacokinetic-pharmacodynamic (PK-PD) relationship of a new drug candidate is very crucial for the drug development process , as t he therapeutic efficacy of antibiotics is very dependent not only on the drug itself but also on whether there is enough drug concentration at the site of infection for a sufficient amount of time that would stop the development of bacterial resistance and on the susceptibility and severity of the infection , as disclosed by Sy . There would be a reasonable expectation of success because analyzing a different drug would not impede the steps of Hirt for analyzing the impact of pregnancy on the pharmacokinetics of a drug, as the analysis steps can be applied to various drugs and populations . Therefore, the invention is prima facie obvious. 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 . Claims 1-7, 10-11 and 13-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19429679 in view of Hirt et al. ( Antimicrobial agents and chemotherapy 2006 , 50(6), 2079-2086 ) and Sy and Derendorf ( In Clinical pharmacology: current topics and case studies 2016, (pp. 185-217). Cham: Springer International Publishing ). This is a provisional nonstatutory double patenting rejection. Conclusion No claims allowed. 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Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center ( EBC ) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /N.D./ Examiner, Art Unit 1686 /Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687