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 1-20 are pending in this office action. 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.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on October 12, 2023 and June 21, 2023 are acknowledged. A signed copy of the two documents are attached to this office action.
Claim Objections
Claims 2, 4, and 15-16 are objected to because of the following informalities:
Claim 2 has the text, “…ingredient (s))…”. Please amend it to read, “…ingredient (s)…”.
Claim 4 has the acronyms ECG, EEG, CT, and MRI. Please define these in full.
In a similar fashion, claims 15-16 have the acronyms Xa, ACE, and AT1. Please define these in full.
Once these are defined, thereafter, the acronym within the claims can be used.
Furthermore, claim 15 has the text, “…selected from the group consisting vitamin…”. Please amend it to read, “…selected from the group consisting of vitamin …”.
Appropriate correction is required.
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.
Claims 1-5 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (WO2017/112290A1).
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).
Regarding instant claim 1, Anderson 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. 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 suffering from a disease state, wherein, optionally, the patient may be exposed to an active ingredient for the treatment of the patient's disease state; (1a) where appropriate, selecting one or more active ingredients to treat the patient's disease state, if the patient has not already been exposed to an active ingredient to treat the disease state; or (1b) where appropriate, selecting one or more other active ingredients for the treatment of the patient's disease state, if the previous active ingredient(s) has disadvantages compared to the other active ingredient based on the analysis of step (1) for the treatment of the patient's disease state;
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.").
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 dosagedetermination module is further to determine at least one of a type of drug to be prescribed, adosage amount of the drug to be prescribed, and a treatment schedule for the drug to beprescribed based additionally on the aggregated patient physiological data and at least one predefined heuristic.”).
(2) determining at least one administration-relevant parameter of the previous active ingredient or of the active ingredient(s) selected according to step (1a) or (1b) for a pharmaceutical form from the analysis of the data according to step (1), where appropriate taking into account potential side effects and/or influences of further active ingredients for the treatment of the same or another disease of the patient to which the patient is exposed;
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).
(3) printing a first dosage form containing the active ingredient(s) according to the at least one administration-relevant parameter determined in step (2) by means of 3D and/or 2D printing, wherein the at least one administration-relevant parameter is converted into one or more corresponding printing parameters for the 3D and/or the 2D printing;
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").
(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").
(5) adjusting the at least one administration-relevant parameter 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").
(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; 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").
Regarding instant claim 2, Anderson et al. teach wherein the administration-relevant parameter(s) is/are selected from the group consisting of amount of active ingredient(s) per unit dose of the dosage form, release kinetics of the active ingredient(s) from the dosage form at the site of administration and/or along the route of the dosage form in the patient, concentration of the active ingredient(s) in the dosage form, distribution of the concentration of the active ingredient(s) in the dosage form, size of the dosage form, geometric shape of the dosage form, coating parameters of the dosage form, surface structure of the dosage form, inner structure of the dosage form, distribution of the active ingredient(s) in the dosage form and combinations of two or more thereof. 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".)
Regarding instant claim 3, Anderson et al. teach wherein the individual parameters of the patient are selected from the group consisting of 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. 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 claim 5, Anderson et al. teach wherein the disease state is selected from the group consisting of diseases of internal organs, rheumatological diseases, oncological diseases, cardiovascular diseases, neurological diseases and hematological diseases. Anderson et al. disclose wherein the disease state includes a disease of the internal organs. This term is extremely broad because it encompasses largely all organs apart from the skin and thus also encompasses, for example, the proposed use within the patient (see paragraph [0053]: "adjust the dosage to include a particular amount of a particular drug that will boost the patient's immune system against illness in a relatively cold environment.").
Regarding instant claims 17-19, Anderson 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".).
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, 5-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. in view of Nie et al. (WO2019/025869A1) and Granger (Transplantation Proceedings, 2001).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. 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).
2. Granger
Granger teaches enteric-coated mycophenolate sodium: results of two pivotal global multicenter trials (see title). In addition, Granger discloses inhibitors of inosine monophosphate dehydrogenase (IMPDH) are effective immunosuppressants; however, the use of mycophenolate mofetil (MMF), one of the most common IMPDH inhibitors, may be limited by dose related gastrointestinal (GI) toxicity. Typical GI-related
disorders associated with MMF include nausea, vomiting, ulcers, gastritis, diarrhea, and abdominal pain. In addition to the GI adverse events, hematological disorders (thrombocytopenia, anemia, leucopenia, and lymphoproliferative disorders) have also been reported. Increases in the incidence of opportunistic infections have also been observed, particularly cytomegalovirus (CMV) infection, which may have a link with some episodes of abdominal pain (see abstract).
The teachings of Anderson et al. are presented in the 35 U.S.C. §102 Section above. Furthermore, the claim limitations of instant claim 1 are taught in full by Anderson et al.
Combination of Anderson et al. and Granger
Regarding instant claim 6, Anderson et al. and Granger teach wherein the disease of internal organs is selected from the group consisting of kidney, liver and pancreas transplantations. Granger discloses wherein the disease condition is a disease of the internal organs, selected from the group consisting of kidney, liver and pancreas transplants (see page 3242, column 1, paragraph 4 within Granger: "renal transplant"). Although the Granger disclosure does not use computer aided 2D and/or 3D printing to administer dosage forms, a skilled artisan (POSITA; person of ordinary skill in the art) would incorporate the appropriate disease condition into the disclosure of Anderson et al.
Combination of Anderson et al. and Nie et al.
Regarding instant claim 7, Anderson et al. and Nie et al. teach wherein the active ingredient(s) is/are selected from the group consisting of glucocorticoids, calcineurin inhibitors and inhibitors of inosine monophosphate dehydrogenase. Nie et al. disclose wherein the active ingredient is a glucocorticoid [see paragraph [0091] within Nie et al.: “a 3D printed dosage form is provided that includes an effective amount of a BCS Class I API…(including) prednisolone”; glucocorticoid active agent].
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 neurological diseases 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 hematological disease 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 cardiovascular diseases are 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 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 claim 20, Anderson et al. and Nie et al. teach a method for producing patient-optimized pharmaceutical dosage forms comprising: printing a pharmaceutical dosage form containing 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; wherein the pharmaceutical dosage form has a size, shape, inner structure and outer structure, and contains an amount of active ingredient(s) selected for a specific patient; and wherein the pharmaceutical dosage form is printed using filament fusion fabrication (FFF), fused layer modelling (FLM), voxel printing, binder jetting, or spot printing. Please see the discussion and citations within instant claims 1-19 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., Nie et al., and Granger 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. and further in light of the claim-specific features described in Granger, in order to arrive at the subject matter of the instant claims.
The Anderson et al., Nie et al., and Granger 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, while Granger supplies an example of a disease of internal organs. 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 three 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. and Granger. The combination of Anderson et al., Nie et al., and Granger 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. and Granger 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. and Granger. Incorporating the disclosure of Anderson et al. into the disease or disorder states presented by Nie et al. and Granger 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. and Granger 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. 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. and Granger 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.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615