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 .
Claim Status
Claims 21-40 are currently pending and under exam herein.
Claims 1-20 have been cancelled.
Claims 21-40 are rejected.
Priority
The instant application is a Continuation of US Application 16/695,489, filed 26 November 2019, now US Patent 11,728,039, which is a Continuation of US Application 15/298,964, filed 20 October 2016, now US Patent 10,522,254, which is a Continuation of US Application 14/596,622, filed 14 January 2015, now US Patent 9,501,622 and claiming the benefit of priority to US Provisional application 61/948,325, filed 5 March 2014. Priority is granted to the Provisional application for each of claims 21-40.
Information Disclosure Statement
The Information Disclosure Statement filed 27 June 2023 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings submitted 27 June 2023 are accepted.
Specification
The abstract of the disclosure is objected to because at line 1, the abstract recites, “Embodiments include methods and systems and for determining a sensitivity of a patient’s blood flow characteristic to anatomical or geometrical uncertainty”. Said recitation is grammatically incorrect and should be amended to recite, for example, “Embodiments include methods and systems for determining a sensitivity of a patient’s blood flow characteristic to anatomical or geometrical uncertainty”, so as to provide a complete sentence structure. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 includes two periods at the conclusion of the claim, reciting “using the machine learning database and the plurality of features..”. Appropriate correction is required by deleting one of the periods.
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.
Claims 21-40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 21, 28, and 35 recite, “determining a sensitivity of a blood flow characteristic of the patient to at least one value of uncertainty in geometry in the geometric model of at least part of the patient’s vascular system, using the machine learning database and the plurality of features” (Machine learning is hereinafter abbreviated as “ML”). The claim is unclear with respect to the step of “using the ML database and the plurality of features” for the process of determining a sensitivity. In step two of the claim, a mapping step occurs so as to map in a ML database, a plurality of features to obtained sensitivities. However, the final step does not delineate what portions of a ML database and features are used for any determination. One interpretation is that the same ML database that appears in claim step two is “used” for the “determining” in said step. Another is that somehow the mapped features are used to make said determination. Without clarity of the language and steps for “using” in the claims are indefinite. For examination purposes, the claim is interpreted as only the ML database as in step two is used for said determination. Further with respect to “use”, there are no specifics on parameters for “use” and as such the claim is limited only to a step of making a determination.
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 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.j sp.
1. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,728,039. The instant claims are directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in a geometric model of a patient’s vascular system. The claims of the ‘039 patent are directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in a geometric model of a patient’s vascular system. The claims in the ‘039 patent include “obtaining, for a plurality of individuals, a geometric model” wherein the instant claims include “obtaining, for a patient, a geometric model” and wherein the ‘039 patent includes a third step of “obtaining a geometric model of a patient’s vascular system”, making it prima facie obvious to one of skill in the art to get geometric model data from a plurality to apply to an individual patient and thus the claims are obvious variants one of the other herein.
2. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,501,622. The instant claims are directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in a geometric model of a patient’s vascular system. The claims of the ‘622 patent are directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in anatomical or geometrical features. The claims of ‘622 patent further include associating vessel regions with a determined sensitivity and identifying vessel regions of interest using am machine learning predictor.
The species “vessel regions” claimed in the conflicting patent or application anticipates the claimed genus (“vascular system”) in the application being examined and, therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus. The instant Specification includes that “regions of interest” can be utilized and that said region encompass vessels of interest [0047] and as such, the instant claims pertain to the genus of “vascular region”.
3. Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,522,254. The instant claims are directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in a geometric model of a patient’s vascular system. The claims of the ‘254 patent are also directed to determining a sensitivity of a patient’s blood flow characteristic to uncertainty in a geometric model of a patient’s vascular system. The ‘254 patent includes calculation of the sensitivity, wherein the instant application :obtains said sensitivity of a blood flow characteristic”.
It would have been prima facie obvious to one of skill in the art to have calculated said sensitivity for the geometric model as a method of “obtaining” as an obvious variant of the method. The prior art to, for example, Sankaran et al. (Journal of Biomechanical Engineering (2011) Vol. 133:12 pages; IDS reference) makes obvious the step of calculating sensitivities (see abstract and entire disclosure, for example calculating sensitivities pertaining to uncertainties).
Conclusion
No claims are allowed.
The instant claims meet the statutory subject matter requirement and are eligible under 35 USC 101 because said claims are not directed to judicially recognized exceptions. The instant claims include steps whereby geometric models are obtained and features are mapped from the model to the sensitives and wherein blood flow sensitivity to uncertainty is determined using said ML database. Said operations are improvements to the technology of cardiac imaging overall and provide non-invasive methodology for assessment of coronary lesions and blood flow and are further not operations that may be performed in the mind nor are they drawn to mathematical concepts, per se. See Specification at least at [0006]-[0010].
The instant claims appear to be free from the prior art as the closest prior art to Sankaran et al. (Journal of Biomechanical Engineering (2011) Vol. 133:12 pages; IDS reference) fail to teach or fairly suggest steps whereby mapping in a machine learning database for the plurality of features is performed or using said database to determine sensitivity of a blood flow characteristic.
It is noted that art of record in the parent applications pertains to applicant’s own work and/or is commonly owned.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Friday from 10 am to 6:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karl Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
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