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 .
This communication is in response to the application filed on 8/8/25. Claims 1-7, 9-11, 13-14, 16, 20-21, 25, 27-28; and 35 are pending.
The IDSs filed on 10/17/25 and 5/22/26 have been considered.
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.
Claim 35 is 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.
Claim 35 recites “[a] computer readable medium comprising instructions which, when executed by one or more processors…” The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. (See MPEP 2106 II and 2106.03 (I) ). When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non-statutory subject matter. See In re Nuijten, 500. F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter).
A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation “non-transitory" to the claim.
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 applicant regards as his invention.
Claims 1-7, 9-11, 13-14, 16, 20-21, 25, 27-28; and 35 is 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 actively recites the step of administering a dosage of Dabigatran to a patient. However, as drafted, it is not clear that other steps recited are actively performed as a part of the claimed method. Examiner suggests that steps be actively recited, rather than nested as part of a wherein clause.
Claims 2-7, 9-11, 13-14, 16, 20-21, 25, 27-28; and 35 inherit the deficiencies of claim 1, through dependendcy, and are therefore also rejected.
As drafted the claim recites a CRM with instructions causing a processor to perform the method of claim 1. However, the first step of claimed method is administering a dosage of dabigatran, an anti-coagulant. It is unclear to the whether the CRM with instructions is merely performing the dosage calculation functions and/or how the instructions cause the processor to perform the step of administering the drug.
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) 1-7, 9-11, 13-14, 16, 20-21, 25, 27-28; and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurst et al( US 20220254457 A1)
Claims 1 and 35 Hurst teaches a method for administering a dosage of dabigatran to a patient for the treatment or prevention of thrombosis, the method comprising: administering a dosage of dabigatran to the patient, wherein the dosage of dabigatran is determined by:
receiving patient data relating to a patient, wherein the patient data includes a kidney function metric of the patient; and (par. 75; Table 2; par. 204)
processing, using one or more processors, the patient data with a dosage calculator to determine the dosage of dabigatran for the patient, (par. 155) wherein the dosage calculator is derived from a plasma level prediction model that predicts dabigatran drug plasma levels, and (par. 46)
the dosage calculator determines the dosage for the patient based in part on the kidney function metric of the patient. (par. 204)
Claim 2. Hurst teaches The method of claim 1, wherein the patient data further comprises one or more of: a patient age; a patient ethnicity; a patient gender; a patient weight; a patient haemoglobin level; a patient left ventricular function; and a patient medication list.(par. 46; par. 79; par. 171)
Claim 3. Hurst teaches he method of claim 2, wherein, the patient medication list comprises an indication of whether the patient is consuming one or medications comprising: a proton-pump inhibitor; a calcium channel blocker; a nonsteroidal anti-inflammatory drug; a H2 receptor antagonists, verapamil, amiodarone, clopidogrel, aspirin, and diltiazem. (par. 154-161; Table 3)
Claim 4. Hurst teaches The method of claim 1, wherein the patient data further comprises one or more of: reported side-effects; alcohol intake; smoking history, a patient clotting metric; a treatment purpose; patient genetic determinants; patient co-conditions; a patient activity level; a patient dosage compliance; a patient liver function; a patient thrombosis history; a patient haemorrhage history; a patient cancer history; a family thrombosis history; familial stroke history, familial bleeding history; cardiovascular history; metabolic history; a patient blood pressure history; a patient platelet count; a patient heart rate; and a patient haematocrit. (par. 152; . par. 46; par. 79; par. 171)
Claim 5. Hurst teaches The method of claim 4, wherein the treatment purpose comprises: prevention of thrombosis, embolism and/or stroke, optionally including patients with non-valvular atrial fibrillation and one or more risk factors including: a previous stroke or transient ischaemic attach, heart failure, diabetes or hypertension; active thrombosis treatment and/or active pulmonary embolism treatment; or prevention of venous thromboembolism in people who have undergone surgery, optionally including hip or knee replacement therapy. (intended use limitation) (par. 5-9)
Claim 6. Hurst teaches The method of claim 1 further comprising: receiving updated patient data; and processing the updated patient data with the dosage calculator to determine an updated dosage; and indicating the updated dosage.(par. 44)
Claim 7. Hurst teaches The method of claim 6, wherein the updated patient data includes a patient clotting metric and/or a drug concentration, from a blood test result, and wherein the method further comprises calibrating the dosage calculator by adjusting the dosage calculator and/or the plasma level prediction model using the patient clotting metric and/or drug concentration. ( par. 9; par. 44)
Claim 9. Hurst teaches The method of claim 1, wherein the plasma level prediction model comprises a time-based differential equation model for modelling a time dependence of a plasma concentration of dabigatran as a function of the patient data. (par. 53-61)
Claims 10. Hurst teaches The method of claim 1, wherein processing the patient data with a dosage calculator to determine the dosage of dabigatran for administering to the patient comprises: receiving a target plasma level metric; and calculating the dosage for administering to the patient by processing the patient data and the target plasma level metric with the dosage calculator .(par. 44)
Claim 11. Hurst teaches The method of claim 1, wherein processing the patient data with a dosage calculator to determine the dosage of dabigatran for administering to the patient comprises: setting an initial value of a dose estimate; processing the dose estimate with the dosage calculator to estimate a plasma level metric; comparing the plasma level metric to a target plasma level metric; and determining the dosage for administering to the patient by refining the dose estimate based on the comparison. (par. 228-230)
Claim 13. Hurst teaches The method of claim 10 wherein the target plasma level metric comprises one or more of: a target trough plasma level comprising an ideal therapeutic level; a target maximum plasma level being less than a maximum level threshold; a target average plasma level over a dosing interval at steady state comprising an ideal therapeutic level; a target area under the curve of a plasma level time profile comprising an ideal therapeutic level; a target ratio of a maximum plasma level to a trough plasma level comprising an ideal therapeutic ratio and level; or a target ratio of the maximum plasma level to the area under the curve of the plasma level time profile comprising an ideal therapeutic ratio and level. (par. 162-165)
Claim 14. Hurst teaches The method of claim 10, wherein the patient data comprises one or more target dependent patient parameters, and wherein the method comprises: determining the target plasma level metric as a personalised target plasma level metric based on the one or more target dependent patient parameters. (par. 162-165)
Claim 16. Hurst teaches The method of claim 14, wherein the personalised target plasma level metric comprises: a trough plasma level comprising a personalised adjustment to an ideal therapeutic level based on the one or more target dependent patient parameters; and/or a ratio of a maximum plasma level to an area under a plasma level time profile being less than a bleeding risk threshold. (par. 162-165)
Claim 20. Hurst teaches The method of claim 1, wherein the dosage calculator comprises a machine learning algorithm trained using the plasma level prediction model. (par. 162-165)
Claim 21. Hurst teaches The method of claim 20, wherein the dosage calculator comprises a machine learning algorithm trained using simulated population data obtained from the plasma level prediction model. (par. 15-16)
Claim 25. Hurst teaches The method of claim 1, wherein the dosage calculator comprises the plasma level prediction model or one or more look-up tables defined according to simulated population data obtained from the plasma level prediction model. (Tables 11-13)
Claim 27. Hurst teaches The method of claim 1 claim, wherein processing the patient data with the dosage calculator to determine the dosage of dabigatran for administering to the patient comprises: processing the patient data with the dosage calculator to determine an ideal dosage regime; and selecting the dosage for administering to the patient from a selection of available dosage regimes based on the ideal dosage regime. (par. 57; par. 83)
Claim 28. Hurst teaches The method of claim 27, wherein the selection of available dosage regimes comprise dosage amounts comprising: 75 mg, 110 mg, 150 mg, any multiple 1 mg, any multiple of 10 mg, or any multiple of 25 mg of dabigatran. (par. 57; par. 83; par. 162-163)
Claim 31 Hurst teaches. The method of claim 1 wherein processing the patient data with the dosage calculator to determine the dosage of dabigatran for administering to the patient comprises processing the patient data with the dosage calculator to determine one or more of: a dosage amount; a dosage time; a dosage frequency; and/or a dosage type. (par. 57; par. 83)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/Primary Examiner, Art Unit 3684
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