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 .
Priority
Acknowledgement is made of Applicant’s claim of the present application being a continuation of U.S. Application No. 18/491,366, filed on October 20, 2023, now U.S. Patent No. 12,484,871, which is a continuation of International Patent Application No. PCT/AU2022/050365, filed on April 21, 2022, and claims the benefit of priority to Australian Patent Application No. AU2021901188, filed on April 21, 2021.
Information Disclosure Statement
The information disclosure statements (“IDS”) filed on 10/24/2024, 01/17/2025 and 03/05/2026 were reviewed and the listed references were noted.
Drawings
The 10-page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-24 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a vessel seed detector to identify …”, “a vessel seed detector configured to …”, “a vessel tracker configured to …”, “an anomaly detector configured to …”, “a vessel wall segmenter configured to …”, and “a disease assessment unit configured to …” in Claim 1-24.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 time-wise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). In order to expedite the processing/approval of the terminal disclaimer, Applicants may choose to file an electronic terminal disclaimer (eTerminal Disclaimer) by referring to the following website:
http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of parent Patent No. 12,484,871. Although the claims at issue are not identical, they are not patentably distinct from each other, because the claims of the instant application are broader in every aspect than the claims in the parent patent, and are therefore, obvious variants thereof. For example, the following chart compares independent Claim 1 of the instant application and Claim 1 of the parent patent.
Instant Application
Patent Application No. 12,484,871
Claim 16. A method of identifying coronary artery disease comprising:
receiving contrast cardiac CT data indicative of a contrast cardiac CT scan carried out on a patient;
using a vessel seed detector to identify in the contrast cardiac CT data, for each of a desired plurality of coronary arteries of the patient, a set of predicted coronary artery centreline seed points;
for each of the desired plurality of coronary arteries, predicting the coronary artery centreline by selecting centreline points from the set of predicted coronary artery centreline seed points;
determining whether all of the coronary artery centrelines of the desired plurality of coronary arteries have been identified;
if all of the coronary artery centrelines of the desired plurality of coronary arteries have not been identified, reconfiguring the vessel seed detector to modify the number of predicted coronary artery centreline seed points identified by the vessel seed detector, and for each coronary artery in respect of which a coronary artery centreline has not been identified, using the reconfigured vessel seed detector to:
identify a reconfigured set of predicted coronary artery centreline seed points;
and predict the coronary artery centreline by selecting centreline points from the reconfigured set of predicted coronary artery centreline seed points;
for each coronary artery of the patient, producing data indicative of transverse image slices of the coronary artery using the contrast cardiac CT data and the identified coronary artery centreline; and
for each coronary artery of the patient, analysing the transverse image slice data to identify presence of coronary artery disease.
Claim 1. A method of identifying coronary artery disease comprising:
receiving contrast cardiac CT data indicative of a contrast cardiac CT scan carried out on a patient;
analysing the contrast cardiac CT data using machine learning to identify a plurality of centreline seed points in the contrast cardiac CT data predicted to correspond to locations on centrelines of the cardiac arteries of the patient by:
analysing the contrast cardiac CT data using machine learning to identify a plurality of predicted centreline seed points; and
determining a plurality of centreline seed points corresponding to predicted locations on centrelines of the coronary arteries using machine learning by predicting from an instant determined centreline seed point a probable direction to a further centreline seed point of the coronary artery, and selecting a predicted centreline seed point from the plurality of predicted centreline seed points using the predicted probable direction to a further centreline seed point of the coronary artery;
producing data indicative of transverse image slices of the cardiac arteries of the patient using the contrast cardiac CT data and the identified centreline seed points;
analysing the transverse image slice data using machine learning to produce inner artery wall data and outer artery wall data indicative of predicted respective inner and outer walls of the coronary arteries of the patient; and
identifying presence of coronary artery disease using the predicted inner and/or outer walls of the coronary arteries of the patient.
Allowable Subject Matter
Claims 1-21 are not rejected over prior art and will be allowed once the above-described rejection based on non-statutory double patenting is overcome. The following is Examiner’s stated reasons for the allowable subject matter: consider Claim 1, Wolterink et al. (“Coronary artery centerline extraction in cardiac CT angiography using a CNN-based orientation classifier” - IDS) discloses “A method of identifying coronary artery disease comprising: receiving contrast cardiac CT data indicative of a contrast cardiac CT scan carried out on a patient; using a vessel seed detector to identify in the contrast cardiac CT data, for each of a desired plurality of coronary arteries of the patient, a set of predicted coronary artery centreline seed points; for each of the desired plurality of coronary arteries, predicting the coronary artery centreline by selecting centreline points from the set of predicted coronary artery centreline seed points” (Wolterink, Abstract discloses “an algorithm that extracts coronary artery centerlines in CCTA using a convolutional neural network (CNN)”. It further discloses “The proposed method is able to accurately and efficiently determine the direction and radius of coronary arteries based on information derived directly from the image data. The method can be trained with limited training data, and once trained allows fast automatic or interactive extraction of coronary artery trees from CCTA images”. And Page 47, right column, second paragraph discloses “We describe an algorithm that utilizes the direction and radius predictions by the CNN to extract centerlines based on a single seed point that can be placed either manually or automatically” ). In an analogous field of endeavor, Buckler et al. (US 2019/0244347 - IDS) discloses “Systems and methods for analyzing pathologies utilizing quantitative imaging are presented herein. Advantageously, the systems and methods of the present disclosure utilize a hierarchical analytics framework that identifies and quantify biological properties/analytes from imaging data and then identifies and characterizes one or more pathologies based on the quantified biological properties/analytes. This hierarchical approach of using imaging to examine underlying biology as an intermediary to assessing pathology provides many analytic and processing advantages over systems and methods that are configured to directly determine and characterize pathology from underlying imaging data” (Buckler, Abstract and Figure 1). In yet another field of endeavor, Isgum et al. (US 2019/0318476 - IDS) discloses obtaining coronary image dataset, extract coronary centerline, create multi-planer reformatted (MPR) image, and create a machine learning based vessel obstruction assessment (VOA) model to predict coronary parameters, and compare with reference standard to determine disease of the coronary (Isgum, Paragraphs [0074]-[0077] and Fig. 2). However, none of the cited prior art references, alone or in combination, provides a motivation to teach the ordered combination of “determining whether all of the coronary artery centrelines of the desired plurality of coronary arteries have been identified; if all of the coronary artery centrelines of the desired plurality of coronary arteries have not been identified, reconfiguring the vessel seed detector to modify the number of predicted coronary artery centreline seed points identified by the vessel seed detector, and for each coronary artery in respect of which a coronary artery centreline has not been identified, using the reconfigured vessel seed detector to: identify a reconfigured set of predicted coronary artery centreline seed points; and predict the coronary artery centreline by selecting centreline points from the reconfigured set of predicted coronary artery centreline seed points; for each coronary artery of the patient, producing data indicative of transverse image slices of the coronary artery using the contrast cardiac CT data and the identified coronary artery centreline; and for each coronary artery of the patient, analysing the transverse image slice data to identify presence of coronary artery disease.” Consider independent Claim 13, none of the cited prior art, alone or in combination, provides a motivation to teach the ordered combination of “an anomaly detector configured to determine whether all of the coronary artery centrelines of the desired plurality of coronary arteries have been identified; wherein if all of the coronary artery centrelines of the desired plurality of coronary arteries have not been identified, the system is arranged to reconfigure the vessel seed detector to modify the number of predicted coronary artery centreline seed points identified by the vessel seed detector, and thereby cause the vessel tracker to produce coronary artery centrelines based on the modified number of predicted coronary artery centreline seed points; a vessel wall segmenter configured to analyse each coronary artery of the patient and produce data indicative of transverse image slices of the coronary artery using the contrast cardiac CT data and the identified coronary artery centreline; and a disease assessment unit configured to analyse the transverse image slice data to identify presence of coronary artery disease.” Dependent Claims 2-12 and 14-24 are not rejected over prior art ed as they depend from the allowable independent Claims 1 and 13, respectively.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
Conclusion and Contact
The prior arts made of record and not relied upon is considered pertinent to Applicant’s disclosure: Gulsun et al. (US 2007/0248250): Fig. 2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Siamak HARANDI whose telephone number is (571)270-1832. The examiner can normally be reached Monday - Friday 9:30 - 6:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amandeep Saini can be reached on (571)272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Siamak Harandi/Primary Examiner, Art Unit 2662
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