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 by preliminary amendment.
Priority
The instant application is a Continuation of US 16/540,440, filed 14 August 2019, now US Patent 11,701,175, which is a Continuation of 15/094,626, filed 8 April 2016, now US Patent 10,420,610 and claiming the benefit of priority to US Provisional application 62/145,714, filed 10 April 2015. Each of claims 21-40 herein is granted priority to 10 April 2015.
Information Disclosure Statement
The Information Disclosure Statements filed 5 June 2023 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Drawings
The Drawings submitted 5 June 2023 are accepted.
Specification
Reference to the Specification herein is to US PG Publication: US20230320789A1.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Process, machine, manufacture/composition of matter Assessment
With respect to step (1): yes, the claims are directed to a computer-implemented method; a system; and a non-transitory computer readable medium for generating a vascular tree model.
Step 2A, Prong 1: Do Claims Recite Abstract Idea Assessment
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Independent Claim 21:
determining, using a processor, one or more associations between a vascular network of a patient-specific vascular model and one or more perfusion characteristics of a target tissue of a patient-specific target tissue model using intensity variation data in one or more patient-specific images of a patient's anatomy; generating, using a processor, a vascular tree model including a microvascular model that extends to perfusion regions in the target tissue, using the determined associations between the vascular network of the patient-specific vascular model and the perfusion characteristics of the target tissue; and providing a diagnosis of cardiovascular disease based on the generated vascular tree model
Independent Claim 32:
determining, using a processor, one or more associations between a vascular network of a patient-specific vascular model and one or more perfusion characteristics of a target tissue of a patient-specific target tissue model using intensity variation data in one or more patient-specific images of a patient's anatomy; generating, using a processor, a vascular tree model including a microvascular model that extends to perfusion regions in the target tissue, using the determined associations between the vascular network of the patient-specific vascular model and the perfusion characteristics of the target tissue; and providing a diagnosis of cardiovascular disease based on the generated vascular tree model.
Independent Claim 40:
Determining, using a processor, one or more associations between a vascular network of a patient-specific vascular model and one or more perfusion characteristics of a target tissue of a patient-specific target tissue model using intensity variation data in one or more patient-specific images of a patient’s anatomy; generating, using a processor, a vascular tree model including a microvascular model that extends to perfusion regions in the target tissue, using the determined associations between the vascular network of the patient-specific vascular model and the perfusion characteristics of the target tissue; and providing a diagnosis of cardiovascular disease based on the generated vascular tree model
The step that recites, “determining one or more associations between a vascular network…and one or more perfusion characteristics…using intensity variation data ” in each of independent claims 21, 32, and 40 is directed to abstract ideas in the category of mental processes whereby one can make a determination of associations by merely visually assessing a model using given intensity data to make a determination of association. Save for using a processor, which is a generic computing processor, said operations contain no additional elements that remove the claim element from this Broadest Reasonable Interpretation (BRI). The same holds for the claim step directed to “generating…a vascular tree model…using determined associations” as there are no specific elements of the claim that go beyond the BRI of doing so using pen and paper (or in this case with the aid of a generic computer as a tool) to “generate” a model. This can be drawn, for example using appropriate data. Last, the step directed to “provide a diagnosis” is one that is a step that is mental in nature whereby one can simply “inform” someone of a diagnosis by assessing the data elements from steps one and two of the claim, and can do so, for example, using a pen and paper.
With respect to dependent claims, the following recite steps that further limit the judicial exceptions in the independent claims and as such, are further directed to abstract ideas:
Claims 26 and 37: directed to further limiting the determination of an association by using mathematical operations of Euclidean distance weights.
Claims 27 and 37:
directed to further limiting the determination of an association by grouping, which can be performed using pen and paper or with the aid of a computer as a tool to place items into groups.
Claims 28 and 38:
directed to further limiting the determination of an association by grouping, performed by mathematical techniques.
Claims 29 and 39:
directed to further limiting the association determination by generating a tree model, which is a mathematical operation and can be done mentally on paper or with the aid of a computer as a tool to perform said mental operation
Claim 30:
directed to further limiting the association determination
Claim 31:
directed to further limiting the association
Dependent claims 22-25 and 33-35 include further limitations on the data of the abstract concepts above.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation. There are no specifics as to the methodology involved in said operations and thus, under the BRI, perform said steps by drawing said models with pen and paper or using a computer as a tool to perform the abstract operations. These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2:Integration to a Practical Application Assessment
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 21-40 include operations by computer-implementation with a processor, data storage, and non-transitory computer-readable medium with executable instruction.
Said steps directed to additional non-abstract elements of “processor; computer; storage medium etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
Step 2B: Do Claims Provide an Inventive Concept Assessment
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to claims 21-40, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The specification herein discloses that computer processors and systems, as example, are commercially available or widely used at [0035]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
Dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
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. 10,420,610, in view of Karch et al. (IDS reference). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims include the exact limitations as recited in each of claims 1-20 of the ‘610 patent. The ‘610 patent additionally include a first step of “receiving a patient-specific vascular model of a patient’s anatomy, the vascular model including a vascular network comprising one or more arteries, arterioles, or capillaries, the patient-specific vascular model being derived from one or more patient-specific images of a patient’s anatomy” and a second step of “receiving patient-specific target tissue model in which to estimate blood supply, the patient-specific target tissue model being derived from the one or more patient-specific images of a patient’s anatomy”. The ‘610 patent lastly includes a forth step, after the “receiving joint prior information…” wherein “receiving data related to the one or more perfusion characteristics of the target tissue” is performed.
It would have been prima facie obvious to one of skill in the art to have “received” the data at steps 1, 2, and 4 of the ‘610 in the context of the instant claimed steps, as a modification to and further detail of the characteristics of the recited patient-specific vascular model and the patient-specific target model herein, in view of the art to Karch et al. who disclose physiological characteristics such as real arterial trees, which may be interpreted as joint prior information as the instant Specification merely defines such to include physiological indications, topological indications etc. (See disclosure herein at least at [0042]; [0043]). The instant Specification defines said models to includes those elements as detailed in the ‘610 application and thus the claims are obvious variants ones of the other.
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. 11,701,175 in view of Karch et al. (IDS reference). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims include the exact limitations as recited in each of claims 1-20 of the, save for the elements in the ‘175 patent that are further directed to “receiving joint prior information associated with a patient-specific vascular model of a patient's anatomy and a patient-specific target tissue model, the joint prior information including geometrical, physiological, and/or topological priors electronically learned from intensity variation data in one or more patient-specific images of the patient's anatomy” a claim element 1 in claim 1 and “calculating an estimation of supplied blood to the target tissue according to the generated vascular tree model” at claim element 4 in claim 1.
It would have been prima facie obvious to one of skill in the art to have “received” the data related to “joint prior” information for determaiton of blood flow as disclosed in the art to Karch et al. (IDS reference) at p. 21 wherein Karch et al. disclose physiological characteristics such as real arterial trees, which may be interpreted as joint prior information as the instant Specification merely defines such to include physiological indications, topological indications etc. (See disclosure herein at least at [0042]; [0043]). Thus the modification to and further detail of the characteristics of the recited patient-specific vascular model and the patient-specific target model herein is obvious. The instant Specification further defines said models to includes those elements and thus the claims are obvious variants ones of the other.
Conclusion
No claims are allowed.
With regard to the closest prior art, the art to Karch (IDS reference) in view of Taylor (8,315,812-IDS reference), does not teach or fairly suggest the particular steps of generating a vascular tree model that includes a microvascular model that extends perfusion regions into the target tissue by using determined associations between the vascular network of the patient-specific vascular model and the perfusion characteristic of the target tissue.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
