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 .
DETAILED ACTION
Claims 1-8 are pending and currently under prosecution.
Priority
3. Applicant’s claim under 35 U.S.C. §§ 119(e) and 365(c) for benefit of the earlier filing date of applications, is acknowledged.
4. 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 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.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (US 20190121935, published on 04/25/2019, IDS).
Claims 1-8 are drawn to a method of providing immunosuppressive therapy to a subject in need of immunosuppression, comprising:
a) administering known dosages of a combination of N immunosuppressive drugs to the subject;
b) performing a time course of p measurement instances of the dosages of the N drugs in the patient;
c) performing a time course of p measurement instances of the therapeutic outcome
of the patient in response to the N immunosuppressive drugs;
d) fitting results of the measurements of the dosages of the N drugs in the patients
and the therapeutic outcomes of the patients to a prediction of therapeutic outcome;
e) using the model of the therapeutic outcome to identify preferred changes to the
dosages of the N immunosuppressive drugs; and
f) treating the patient with the changed dosages of the N immunosuppressive drugs,
wherein N is an integer of 2 or more,
wherein the model of therapeutic outcome is a quadratic function of dosages of the N drugs with m parameters where m = 1 + 2N + (N(N-1))/2, wherein mis the number of
parameters needed, and wherein p ≥ m.
Ho et al. teach a method for applying drugs to treat a human patient following organ transplantation, the method comprises : (1) deriving an initial phenotypic map for a patient subjected to an initial therapeutic regimen including a first drug and a second drug, based on values of a phenotypic output for the patient and corresponding values of doses of the first drug and the second drug; (2) following a change from the initial therapeutic regimen to an updated therapeutic regimen, receiving an updated value of the phenotypic output for the patient subjected to the updated therapeutic regimen; (3) re-calibrating the initial phenotypic map according to the updated value of the phenotypic output; and (4) using the re-calibrated phenotypic map, identifying values of the doses of the first drug and the second drug for the patient subjected to the updated therapeutic regimen; wherein deriving the parameters of the individual phenotypic map includes fitting the values of the therapeutic outcome and the corresponding values of the dose of the drug with respect to a quadratic function relating the therapeutic outcome and the dose of the drug, a total number of parameters p is 1+2m+(m(m−1))/2, wherein m is drug; see entire document, e.g., title, abstract, [0006], [0027], [0046], [0068-0112], claims 1-17, Table 1.
For claims 2-3, Ho et al. teach optimizing liver transplant immunosuppression using a phenotypic personalized medicine platform; see page 9.
For claim 4, Ho et al. teach drugs (m) is 3 or more; see Table 1.
For claims 6-7, Ho et al. teach that immunosuppressive drugs include tacrolimus (calcineurin inhibitor), mycophenolate (immunosuppressant), prednisone (anti-inflammatory); see [0072-0076].
For claim 8, Ho et al. teach parameters p comprises immunosuppression drug dose; see [0046-0047], Table 1.
Double Patenting
7. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 1, 4-5 and 8 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,603,390. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1, 4-5 and 8 are drawn to a method of providing immunosuppressive therapy to a subject in need of immunosuppression, comprising:
a) administering known dosages of a combination of N immunosuppressive drugs to
the subject;
b) performing a time course of p measurement instances of the dosages of the N
drugs in the patient;
c) performing a time course of p measurement instances of the therapeutic outcome
of the patient in response to the N immunosuppressive drugs;
d) fitting results of the measurements of the dosages of the N drugs in the patients
and the therapeutic outcomes of the patients to a prediction of therapeutic outcome;
e) using the model of the therapeutic outcome to identify preferred changes to the
dosages of the N immunosuppressive drugs; and
f) treating the patient with the changed dosages of the N immunosuppressive drugs,
wherein N is an integer of 2 or more,
wherein the model of therapeutic outcome is a quadratic function of dosages of the N drugs with m parameters where m = 1 + 2N + (N(N-1))/2, wherein mis the number of
parameters needed, and wherein p ≥ m.
Claims 1-4 of U.S. Patent No. 10,603,390 are drawn to a method, comprising: for a combination of N drugs with N being 2 or more, representing a model of a therapeutic outcome as a quadratic function of dosages of the N drugs, wherein the quadratic function includes m parameters, with m=1+2N+(N(N<1))/2; applying the combination of the N drugs to a patient; performing measurements at p measurement instances of a time course variation of the dosages of the N drugs in the patient, wherein p≥m; performing measurements at the p measurement instances of a time course variation of the therapeutic outcome of the patient in response to the N drugs; fitting results of the measurements of the dosages and the therapeutic outcome into the model of the therapeutic outcome; using the model of the therapeutic outcome to identify optimized dosages of the N drugs; and treating the patient with the optimized dosages of the N drugs.
9. Claims 1-8 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8, 11, 13 and 25 of copending Application No. 18/684546. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-8 are drawn to a method of providing immunosuppressive therapy to a subject in need of immunosuppression, comprising:
a) administering known dosages of a combination of N immunosuppressive drugs to
the subject;
b) performing a time course of p measurement instances of the dosages of the N
drugs in the patient;
c) performing a time course of p measurement instances of the therapeutic outcome
of the patient in response to the N immunosuppressive drugs;
d) fitting results of the measurements of the dosages of the N drugs in the patients
and the therapeutic outcomes of the patients to a prediction of therapeutic outcome;
e) using the model of the therapeutic outcome to identify preferred changes to the
dosages of the N immunosuppressive drugs; and
f) treating the patient with the changed dosages of the N immunosuppressive drugs,
wherein N is an integer of 2 or more,
wherein the model of therapeutic outcome is a quadratic function of dosages of the N drugs with m parameters where m = 1 + 2N + (N(N-1))/2, wherein mis the number of
parameters needed, and wherein p ≥ m.
Claims 1-8, 11, 13 and 25 of copending Application No. 18/684546 are drawn to a method for determining an immunosuppressant dosage for a patient after an organ transplant, the method comprising: obtaining a first dosage of an immunosuppressant drug administered to a patient on a first time period; obtaining a first serum level of the patient associated with the first time period; determining a second dosage of the immunosuppressant drug based on a first immunosuppressant ratio between the first dosage and the first serum level; generating a first output based on the second dosage; wherein: the second dosage associated with a second time period; and the first time period immediately precedes the second time period.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
