DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 3-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) a method of calculating a dose. This judicial exception is not integrated into a practical application because the method requires only mathematical steps to arrive at a number, it is therefore a purely abstract method. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no addition steps are required and therefore no step which makes the abstract idea tied to a practical application nor recites steps which are more than mental steps.
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 5-9, 11-14 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.
Claims 5-9, 11-14 recite the term “sub-optimal”, this term is not defined in the specification and is a subjective or relative term that renders the claim indefinite. It is unclear how sub-optimal is determined and what level might be considered sub-optimal. Further in any treatment the optimal goal could be defined in a multitude of ways. This renders the claims indefinite as it is unclear what the metes and bounds of the invention are as a treatment may be sub optimal or not depending on the definition used. For example optimal may be results for a specific time frame, a different time frame may result in a different optimum. The size of an organ, a level of a biomarker or amount of different enzymes may be the optimal response, the optimum for these responses may all be different concentrations.
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 3-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12076376. Although the claims at issue are not identical, they are not patentably distinct from each other because, Claims 3-4 claim methods of calculating the amount of therapeutic to used in glass vials. The ability to determine the amount of containers of a therapeutic based on the desired dosage is obvious to one of ordinary skill in the art as it is a routine and necessary step of administering a therapeutic. The claims recite glass vial however glass vials are routine and further these are mental steps that don’t impose a limitation on the abstract idea. Claims 1-7 claim the administration of the same therapeutic claimed for treatment of those in need via the same routes and populations at the same inteverals as instantly claimed. Claims 5-15 differ from claims 1-7 of ‘376 by requiring changes based on “sub-optimal” responses using known biomarkers. These limitations would be obvious based on the claims of 1-7 as the determination of effective dosages based on known biomarkers and assays are routine to therapeutic treatments.
The claims of ‘376 thus render obvious the instant claims.
Claims 3-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10166274. Although the claims at issue are not identical, they are not patentably distinct from each other because, Claims 3-4 claim methods of calculating the amount of therapeutic to used in glass vials. The ability to determine the amount of containers of a therapeutic based on the desired dosage is obvious to one of ordinary skill in the art as it is a routine and necessary step of administering a therapeutic. The claims recite glass vial however glass vials are routine and further these are mental steps that don’t impose a limitation on the abstract idea. Claims 1-7 claim the administration of the same therapeutic claimed for treatment of those in need via the same routes and populations at the same intervals as instantly claimed. Claim 2 further teaches monitoring biomarkers. Claims 5-15 differ from claims 1-7 of ‘274 by requiring changes based on “sub-optimal” responses using additional known biomarkers. These limitations would be obvious based on the claims of ‘274as the determination of effective dosages based on known biomarkers and assays are routine to therapeutic treatments.
The claims of ‘274 thus render obvious the instant claims.
Claims 3-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 8663631. Although the claims at issue are not identical, they are not patentably distinct from each other because, Claims 3-4 claim methods of calculating the amount of therapeutic to used in glass vials. The ability to determine the amount of containers of a therapeutic based on the desired dosage is obvious to one of ordinary skill in the art as it is a routine and necessary step of administering a therapeutic. The claims recite glass vial however glass vials are routine and further these are mental steps that don’t impose a limitation on the abstract idea. Claims 1-32 claim the administration of the same therapeutic claimed for treatment of those in need via the same routes and populations at the same intervals as instantly claimed. Claim 2-8 further teaches monitoring biomarker sincluding AST, ALT heptomegly. Claims 5-15 differ from claims 1-32 of ‘631 by requiring changes based on “sub-optimal” responses using the same biomarkers that are being monitored in the claims of ‘631. These limitations would be obvious based on the claims of ’631 as the determination of effective dosages based using monitored biomarkers is routine to therapeutic treatments.
The claims of ‘631 thus render obvious the instant claims.
Conclusion
Claims 1-2 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657
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