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 .
Summary
Claims 1-4 and 8-20 are pending in this office action. Claims 5-7 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on October 12, 2023 is a 371 of PCT/EP2021/084678 filed December 7, 2021. The current application claims foreign priority to EP20212320.4 filed December 21, 2020.
Claim Objections
Claims 1-4 and 8-20 are objected to because of the following informalities:
Claim 1: At the end of (2) please insert a colon and list each parameter as a bullet point or 1, 2, 3, 4, etc. Within step (5) delete “at least one” and make “parameter” plural to be consistent with the earlier portion of the claim. Within step (6) the Applicant did not include deletion of the text “optionally.”
Dependent claims 2-4 and 8-20 are included here because they fail to cure the defects of claim 1.
Claim 2: Additionally, please make “multi layer” hyphenated (multi-layer).
Appropriate correction is required.
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 non-obviousness.
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 1-4 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (WO2017/112290A1) in view of Nie et al. (WO2019/025869A1).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Anderson et al.
Anderson et al. is the closest prior art to the present invention as it teaches a server and method for determining a drug for a patient (see title). Furthermore, Anderson et al. disclose that technologies for customized drug provisioning include a drug dosage determination server and a drug dispenser device. The drug dosage determination server is configured to obtain patient physiological data associated with a patient, determine a drug dosage for the patient based on the patient physiological data, generate drug dosage instructions for a drug dispenser device, based on the determined drug dosage, and transmit the drug dosage instructions to the drug dispenser device. The drug dispenser device is configured to receive drug dosage instructions from the drug dosage determination server, prompt the patient for authentication credentials, determine whether the patient is authenticated, generate the drug based on the drug dosage instructions in response to a determination that the patient is authenticated, and dispense the drug. Other embodiments are described (see abstract).
2. Nie et al.
Nie et al. teach additively manufactured controlled release dosage forms (see title). In addition, Nie et al. disclose 3D printed functional dosage forms, and methods for making thereof are disclosed. In one aspect of the disclosure, a dosage form is presented that includes an outer shell printed from a first material and at least one inner core containing an active pharmaceutical ingredient (API) disposed within the outer shell. The dosage form includes an opening structure extending from an outer surface of the outer shell to the at least one inner core. The dosage form may include a plurality of pH sensitive mucoadhesive projections printed from a third material and extending from the outer shell. The dosage form may include a plug printed from the second or third material within the opening structure and can include an outer cap printed over the plug from a fourth material. The dosage form also may include an internal hollow cavity such that the dosage form is buoyant in an aqueous solution (see abstract).
Combination of Anderson et al. and Nie et al.
Regarding instant claim 1, Anderson et al. and Nie et al. teach a method for producing patient-optimized pharmaceutical dosage forms. The necessary citations of Anderson et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Anderson et al. and Nie et al. Citations
A method for producing patient-optimized pharmaceutical dosage forms comprising the steps of: (1) analyzing of individual and/or disease-related data of a patient after administrating one or more active ingredients;
Anderson et al. disclose a method for producing patient-optimized pharmaceutical dosage forms
(see claim 13: "method for determining a drug dosage for a patient"; problem addressed according to paragraph [0002]: "the patient continues to consume doses of the drug in accordance with a prescription that was prepared based on conditions that have since changed."); (also see claim 1 “A drug dosage determination server for determining a drug dosage for a patient,
the drug dosage determination server comprising:
a physiological data aggregator module to obtain patient physiological data from physiological sensors associated with the patient; a drug dosage determination module to determine a drug dosage for the patient based on the obtained patient physiological data and to generate drug dosage instructions for a drug dispenser device, based on the determined drug dosage, wherein the drug dosage instructions are usable by the drug dispenser device to generate a drug; and
a communication module to transmit the drug dosage instructions to the drug dispenser device.” all within Anderson et al.).
Step (1): analyzing individual and/or and disease-related data of a patient suffering from a disease condition (see claim 13: "obtaining, by a drug dosage determination server, patient physiological data from physiological sensors associated with the patient"; also see paragraphs [0015], [0035], [0038] and [0049]; and figure 6, 604: "patient physiological sensors 110 are configured to monitor various characteristics of the patient's health, activities, and environment as discussed below; the drug dosage determination server 102 may also consider the patient's health history and medical records (e.g., allergies, past reactions to drugs, etc.), which may be obtained from the health history server 106"; also see claim 4: “wherein the drug dosage determination module is further to determine at least one of a type of drug to be prescribed, a dosage amount of the drug to be prescribed, and a treatment schedule for the drug to be prescribed based additionally on the aggregated patient physiological data and at least one predefined heuristic.” all within Anderson et al.).
(2) determining administration-relevant parameters of a pharmaceutical dosage form from the analysis of data of step (1), wherein the administration-relevant parameters are a composition of the dosage form, an amount of the active ingredient(s) per unit dose of the dosage form, a distribution of the active ingredient(s) in the dosage form, an inner structure of the dosage form, a dissolution rate of the active ingredient(s) from the dosage form, and a surface coating of the dosage form;
Step (2): determining at least one administration-related parameter of the previous active substance for a dosage form on the basis of the analysis of the data according to step (1) (see claim 13: "determining, by the drug dosage determination server, the drug dosage for the patient based on the obtained patient physiological data"; also see paragraph [0053]; and figure 7, 622; "determine drug dosage based on patient physiological data 630, patient's health history 632, patient's schedule 634"; using the patient’s health history and physiological data ensures monitoring of the subject; all within Anderson et al.).
Nie et al. disclose the manufacture of controlled release dosage forms by a 3D printer (see title and abstract within Nie et al.). Furthermore, Nie et al. disclose “a 3D printed functional dosage form comprising an outer shell printed from a first material, at least one inner core disposed within the outer shell, the inner core being printed from a second material including an active pharmaceutical ingredient (API) [a composition of the dosage form] [an amount of the active ingredient(s) per unit dose of the dosage form] [a distribution of the active ingredient(s) in the dosage form] [an inner structure of the dosage form] [a dissolution rate of the active ingredient(s) from the dosage form] [and a surface coating of the dosage form]; and an opening structure extending from an outer surface of the outer shell to the at least one inner core.” (see claim 1 within Nie et al.).
(3) printing a first dosage form containing the active ingredient(s) according to the administration-relevant parameters determined in step (2) by means of 3D and/or 2D printing, wherein the administration-relevant parameters are converted into one or more corresponding printing parameters for the 3D and/or the 2D printing to provide the first dosage form with a desired controlled release of the active ingredient(s) from the first dosage form;
Step (3): printing, by means of 3D and/or 2D printing, a first dosage form containing the active substance(s) in accordance with the at least one administration-related parameter determined in step (2), the at least one administration-related parameter being converted into one or more corresponding printing parameters for the 3D and/or 2D printing (see claim 13: "generating by the drug dosage determination server, drug dosage instructions for a drug dispenser device, based on the determined drug dosage[…],and transmitting, by the drug dosage determination server, the drug dosage instructions to the drug dispenser device"; also see paragraphs [0057]-[0058]; and figure 8, 648 and 652: "drug dosage determination server 102 generates drug dosage instructions 516 that are usable (e.g., as executable instructions) by the drug dispenser device 102 to control the generation of drug doses and the dispensing of the drug doses; when drug dispenser device 102 is embodied as a 3D printer, drug dosage determination server 102 may generate 3D drug printing instructions 650 based on the determined drug dosage, configured to be executed by the drug dispenser device 102 to print the drug into a pill or other form"; finally see paragraph [0062]; figure 10, 900, 930, 940: "the drug dispenser device 104 generates the drug based on the drug dosage instructions 516 and dispenses the drug dosage to the patient" all within Anderson et al.).
Nie et al. disclose a controlled release dosage form based on the printed shells that surround the active pharmaceutical intermediate (API) (see abstract within Nie et al.).
(4) analyzing individual and disease-related data of the patient under administration of the first dosage form;
Step (4): analyzing individual and disease-related data of the patient under administration of the first dosage form (see claim 23: "further comprising determining, by the drug dosage determination server, health threat data for the drug dosage"; also see paragraph [0058]: [following transmission of the dosage instructions to the printer 652] "method 600 may subsequently loop back to block 602 of Fig.6 in which the drug dosage determination server 102 obtains additional patient physiological data"; and paragraphs [0039] and [0054]; further see figure 7, 636 and 638: "The health threat analysis module 407 is configured to identify threats to a patient based on one or more sources of data, including current physiological conditions of a patient"; all within Anderson et al.).
(5) adjusting the administration-relevant parameters of the active substance or substances for a dosage form according to the analysis of the data according to step (4);
Step (5): adjusting at least one administration-related parameter of the active substance(s) for a dosage form on the basis of the analysis of the data according to step (4) (see claim 23; and paragraph [0039]: "and adjusting, by the drug dosage determination server, the drug dosage instructions based on the health threat data"; also see paragraph [0056]; and figure 7, 646: "the method 600 loops back to block 622 in which the drug dosage determination server 102 adjusts the drug dosage to account for the identified health threat"; all within Anderson et al.).
(6) printing a further dosage form containing the active ingredient(s) according to the at least one administration-relevant parameter adjusted in step (5) by means of 3D and/or 2D printing to provide the further dosage form with a desired controlled release of the active ingredient(s) from the further dosage form; and, optionally (7) repeating steps (4) to (6).
Step (6): printing, by means of 3D and/or 2D printing, a further dosage form containing the active substance(s) in accordance with the at least one administration-related parameter adjusted in step (5) (see paragraph [0056]; and figure 7, 622-636: "drug dosage determination server 102 may execute blocks 622, 636 periodically or continually to monitor for trending health threats and adjust a patient's previously determined prescription response to an identified health threat and/or preemptively"; also see paragraph [0063]; and figure 10: "method 900 subsequently loops back to block 904 in which the drug dispenser device 104 again determines whether to dispense a drug"; all within Anderson et al.).
Nie et al. disclose a controlled release dosage form based on the printed shells that surround the active pharmaceutical intermediate (API) (see abstract within Nie et al.).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Anderson et al. with the teachings of Nie et al. to create a method for producing patient-optimized pharmaceutical dosage forms. The motivation for doing so would have been to develop 3D printing option incorporating controlled release dosage forms.
Regarding instant claim 2, Anderson et al. and Nie et al. teach wherein the
inner structure of the dosage form is a multi-layer structure built up layer by layer by a jetting process.
Anderson et al. disclose determination of the amount of active ingredient(s) per unit dose of the dosage form, the concentration of the active ingredient(s) in the dosage form [amount of active substance; see claims 19-22; paragraph [0053]; figure 7, 624, 625, and 628: "comprising determining a dosage amount for the patient"], and the overall structure of the drug to be administered (see paragraphs [0057]-[0058]; and figure 8, 648 and 652: "drug dosage determination server 102 generates drug dosage instructions 516 that are usable (e.g., as executable instructions) by the drug dispenser device 102 to control the generation of drug doses and the dispensing of the drug doses; when drug dispenser device 102 is embodied as a 3D printer, drug dosage determination server 102 may generate 3D drug printing instructions 650 based on the determined drug dosage, configured to be executed by the drug dispenser device 102 to print the drug into a pill or other form"; all within Anderson et al.). Nie et al. disclose “the printing process can occur at different stages during the printing process. During polyjet printing, for example, curing can occur after each layer is deposited, after a partial layer has been deposited, or even after multiple layers have been deposited.” (see paragraph [0072] within Nie et al.).
Regarding instant claim 3, Anderson et al. and Nie et al. teach wherein the individual parameters of the patient are selected from the group consisting of a disease state, age, gender, developmental state, genetic predispositions, height, weight, body surface area, body mass index, general physical condition, drug consumption, eating and drinking habits, sleeping habits, physical activity, and combinations of two or more thereof.
Anderson et al. disclose the age, weight, genetic predispositions (health history), and physical activity data are collected from the patient (see paragraphs [0049] and [0051][0052]; and figure 6, 604, 618, and 620, e.g. "adverse reactions to certain drugs"; also see paragraph [0053]; figure 7, 630, 632, and 634: "For example, the drug dosage determination server 102 may adjust the dosage of the drug based on the weight and/or age of the patient[... ] to include a particular amount of a particular drug that will reduce exhaustion during a scheduled sports activity.").
Regarding instant claim 4, Anderson et al. and Nie et al. teach wherein the disease-related data are selected from the group consisting of blood pressure, heart rate, ECG findings, EEG findings, sonographic findings, CT findings, MRI findings, biopsy findings of diseased tissue, blood count, electrolyte blood levels, blood liver levels, nephrological blood and urine levels, blood lipid levels, blood glucose levels, vitamin metabolism data, metabolic interactions, medication schedule, side effect profiles, urine status, virological findings, bacteriological findings, fungal findings, parasitic findings, stage of disease, course of disease and combinations of two or more thereof.
Anderson et al. disclose disease-related data is obtained for a subject such as blood pressure, heart rate, and EEG reports (see paragraphs [0049] and [0051]-[0052]; figure 6, 604, 618, and 620; also see paragraph [0053]; figure 7, 604, e.g. "patient physiological data obtained from a heart rate sensor; a blood pressure sensor; and an electroencephalogram (EEG)".).
Regarding instant claims 8 and 9, Anderson et al. and Nie et al. teach wherein the disease state is a rheumatological disease and the active ingredient(s) is/are selected from the group consisting of glucocorticoids, calcineurin inhibitors, inhibitors of inosine monophosphate dehydrogenase and inhibitors of tyrosine kinase.
Nie et al. teach wherein the disease state is a rheumatological disease and the active ingredient is inhibitors of tyrosine kinase [see paragraphs [0130-0133] within Nie et al.: “CEP-701 is a tyrosine kinase inhibitor with limited solubility in water of ~0.3 ug/ml. CEP-701 is classified as a Biopharmaceutics Classification System (BCS) Class II molecule having high permeability, low solubility, as defined by the U.S. FDA Center for Drug Evaluation and Research (CDER).”; oncology agent (inflammation)].
Regarding instant claim 10, Anderson et al. and Nie et al. teach wherein the disease state is Morbus Parkinson and the active ingredient(s) is/are selected from dopamine antagonists.
Nie et al. disclose wherein the neurological diseases is Morbus Parkinson and the active ingredient(s) is/are selected from dopamine antagonists [see paragraph [0093] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class Ill API.…(including) chlorpromazine hydrochloride”; Parkinson’s Disease active agent and dopamine antagonist].
Regarding instant claims 11 and 12, Anderson et al. and Nie et al. teach wherein the disease state is an anemia.
Nie et al. disclose wherein the hematological disease is an anemia [see paragraph [0093] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class Ill API.…(including) folic acid”; anemia active agent].
Regarding instant claims 13 and 14, Anderson et al. and Nie et al. teach wherein the disease state is selected from the group consisting of high blood pressure, stroke, ventricular fibrillation and risk for heart attack.
Nie et al. teach wherein the cardiovascular disease is high blood pressure (hypertension) [see paragraph [0094] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class IV API.…(including) furosemide”; diuretic and anti-hypertensive active agent].
Regarding instant claim 15, Anderson et al. and Nie et al. teach wherein the anticoagulants are selected from the group consisting of vitamin K antagonists, thrombin inhibitors and coagulation factor Xa inhibitors.
Nie et al. disclose wherein the anticoagulants are vitamin K antagonists [see paragraph [0091] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class II API.…(including) warfarin”; vitamin K antagonist active agent].
Regarding instant claim 16, Anderson et al. and Nie et al. teach wherein the antihypertensive drugs are selected from the group consisting of calcium antagonists, betablockers, ACE inhibitors, diuretics and AT1 inhibitors.
Nie et al. disclose wherein the antihypertensive drugs are calcium antagonists [see paragraph [0091] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class II API.…(including) amlodipine”; calcium antagonist active agent].
Regarding instant claims 17-19, Anderson et al. and Nie et al. teach wherein several steps are carried out with the aid of a computer.
Please see the discussion and citations within instant claims 1-5. Additionally, Anderson et al. disclose method steps that take place in a computer-assisted manner (see paragraphs [0013] and [0015]; figure 1, "drug dosage determination server 102".).
Regarding instant claim 20, Anderson et al. and Nie et al. teach a method of instant claim 1 wherein the one or more active ingredient(s) selected from the group consisting of glucocorticoids, calcineurin inhibitors, inhibitors of inosine monophosphate dehydrogenase, inhibitors of tyrosine kinase, dopamine antagonists, iron preparations, vitamin B12, folic acid, calcium antagonists, betablockers, ACE inhibitors, diuretics, AT1 inhibitors, vitamin K antagonists, thrombin inhibitors and factor Xa inhibitors.
Please see the discussion and citations within instant claims 1-4 and 8-19 for the necessary rejection text. [This instant claim combines many of the earlier presented limitations.] In addition, Anderson et al. disclose preparation of a pharmaceutical dosage having a particular structure (see paragraph [0012] within Anderson et al.: references in the specification to "one embodiment," "an embodiment," "an illustrative embodiment," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may or may not necessarily include that particular feature, structure, or characteristic). Furthermore, Nie et al. disclose functional dosage techniques (see paragraph [0072] within Nie et al. including “FFF, FDM, HME, SLS, SLA, and inkjet or polyjet printing”).
Analogous Art
The Anderson et al. and Nie et al. references are directed to the same field of endeavor as the instant claims, that is, a method for producing patient-optimized pharmaceutical dosage forms disclosed within instant claim 1.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method for producing patient-optimized pharmaceutical dosage forms disclosed by Anderson et al., using the teachings of Nie et al. in order to arrive at the subject matter of the instant claims.
The Anderson et al. and Nie et al. references all have considerable overlap with the treatment of disease states. In this instance, both Anderson et al. and Nie et al. supply the method for producing patient-optimized pharmaceutical dosage for different disease states or disorders, and Nie et al. further discloses controlled release dose forms. All references are directed to the treatment of various disease states and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the two references when seeking to improve or adapt a method for producing patient-optimized pharmaceutical dosage forms.
Starting with Anderson et al., the skilled person only had to try the necessary claim limitations disclosed by Nie et al. The combination of Anderson et al. and Nie et al. would allow one to arrive at the present application without employing inventive skill. This combination of the method for producing patient-optimized pharmaceutical dosage forms taught by Anderson et al. along with the use of the necessary claim limitations taught by Nie et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the method for producing patient-optimized pharmaceutical dosage forms disclosed by Anderson et al. with the use of the necessary claim limitations taught by Nie et al. Incorporating the disclosure of Anderson et al. into the disease or disorder states presented by Nie et al. represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Nie et al. would have been viewed by a POSITA as routine design optimizations or known modifications to expand the applicable treatment of diseases or disorders with therapeutics. The motivation for doing so would have been to develop 3D printing option incorporating controlled release dosage forms into the therapeutics. Implementing these features in Anderson et al.’s patient-optimized pharmaceutical dosage forms would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Anderson et al., supplemented by Nie et al. provides all the elements of the claimed invention. The resulting method for producing patient-optimized pharmaceutical dosage forms constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Response to Arguments
Applicant's arguments filed June 29, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the claim objections and the 35 U.S.C. §102 rejection. Therefore, they are both withdrawn from the non-final office action dated December 29, 2025.
The amendments did not necessitate a new ground of rejection. The Granger reference was withdrawn from the record due to the cancellation of instant claim 6.
Applicant Argument: The Applicant argues that Anderson et al. does not disclose a controlled release dosage form.
Examiner’s Rebuttal: The 35 U.S.C. §102 rejection has been withdrawn from the record due to the lack of controlled release dosage forms within Anderson et al. However, a combination of Anderson et al. and Nie et al. form a strong 35 U.S.C. §103 rejection. Anderson et al. supplies the patient-optimized pharmaceutical dosage for different disease states or disorders, while Nie et al. supplies the controlled release dosage forms. Both analogous art references employ 3D printing.
[Furthermore, Applicant may also argue impermissible hindsight reasoning. However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight [or piece-meal reasoning.] But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).]
Thus, the 35 U.S.C. §103 rejection for instant claims 1-4 and 8-20 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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