CTNF 17/955,688 CTNF 88073 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement 06-49-06 AIA The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Double Patenting 08-33 AIA 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. 08-37 AIA Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/722,562 in view of Zilberstien et al. U.S. Patent Publication No. 20190355118 (hereinafter “Zilberstien”). Although the claims at issue are not identical, they are not patentably distinct from each other because the sole differentiating claim limitation is directed to calculating blood flow energies. Zilberstien discloses improving image accruace based on calculations of a functional index parameters for an anatomical territory of a blood vessel (see paragraph [0008]). Therefore, one of ordinary skill in the art at the time the invention was filed, would have concluded that the incorporation of Zilberstien into the instant application would provide a mthod of utilizing additional imaging data to model blood vessels . This is a provisional nonstatutory double patenting rejection. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 3 is 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. In regard to claim 3, the claim contains a formula that contains variables that are not defined in the claim itself nor the claim(s) from which it depends. Specifically, the variables ᵖ, Q, and U are not explicitly or implicitly defined. Therefore, the scope of the claim is unclear. 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, the computer readable medium does not further limit the scope of claim 1 as it only specifies limitations directed to the computer readable medium . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 (i.e., changing from AIA to pre-AIA) 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. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim (s) 1,2, 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Malota et al. U.S. Patent Publication No. 2020/0105420 (hereinafter “Malota”) in view of Taylor U.S. Patent Publication No. 2012/0053918 (hereinafter “Taylor”) . In regard to claim 1, Malota teaches A computer-implemented method for modelling blood vessels, the method comprising steps of: obtaining medical imaging data of the blood vessels (Fig. 2a step 11, Paragraphs [0023], [0065]-[0066] disclose obtaining medical imaging data for blood vessels); generating a three-dimensional model of the blood vessels, based on the medical imaging data including identifying one or more pathological plaques (Figure 6, Paragraphs [0023] and [0065]-[0066] disclose obtaining a three dimensional model that includes plaques.); generating a three-dimensional reconstructed model of the blood vessels that reflects the condition of healthy blood vessels and lacks lesions visible in the results of medical imaging (Figure 2a, Paragraphs [0023], [0065]-[0066] disclose generating a reference model that includes a state of healthy blood vessels that lack lesions that is based on a reconstruction.); performing pre-simulation of the three-dimensional model, establishing boundary conditions and initial conditions for both models for a steady flow of blood and a transient flow of blood (Paragraph [0068] discloses a simulation step using pre-established identical physical and boundary conditions as well as flow simulation for laminar flow and turbulent flow.) ; performing a numerical simulation of the transient flow of blood, for selected physical and boundary conditions, for the three-dimensional model for an increasing blood flow rate that increases from a laminar flow to a developed turbulent flow, the simulation comprising, determined during the pre-simulation, initial conditions of blood flow (Paragraph [0068] discloses a simulation step using pre-established identical physical and boundary conditions as well as flow simulation for laminar flow and turbulent flow. The simulation using a numerical flow simulation for an increasing inlet flow rate starting with from an absence of flow, through start of the flow, until achieving a developed turbulent flow.); performing a numerical simulation of the steady flow of blood, for selected physical and boundary conditions, for the three-dimensional model for transitional or turbulent flow, the simulation comprising, determined during the pre-simulation, initial conditions of blood flow ( Paragraph [0068] discloses a simulation step using pre-established identical physical and boundary conditions as well as flow simulation for laminar flow and turbulent flow. The simulation using a numerical flow simulation for an increasing inlet flow rate starting with from an absence of flow , through start of the flow, until achieving a developed turbulent flow.); However, where Malota does not explicitly teach, Taylor discloses and for a selected plaque, identifying geometrical parameters of a surface of the plaque, including shape, curvature, curvature of the major surface, and/or Gauss curvature of the plaque surface (Taylor Paragraphs [0145]-[0148] disclose using a computer system to determine the geometry of a plaque in a blood vessel.) . Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to make the combination of Malota and Taylor, in order to enable the user to make corrections to the imaging data as necessary to reduce inaccuracies (Taylor Paragraph [0149]). In regard to claim 2, Malota, in view of Taylor, teaches The method of claim 1, comprising determining a pressure force acting on the plaque surface at any one or more points as a force acting on a fixed curved wall of the atherosclerotic plaque for a steady flow and/or for a transient flow (Taylor Paragraphs [0302]-[0304] disclose identifying pressures acting on the plaques within the vessel to assess risk of plaque rupture). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed, to make the combination of Malota and Taylor, in order to determine plaque rupture risk (Taylor [0304]). In regard to claim 4, Malota, in view of Taylor, teaches The method of claim 1, further comprising determining a probability of rupture or damage to the plaque, by comparing the pressure force present in the plaque with a reference pressure force for normal, healthy coronary vessels, based on a calculated Reference Dynamic Pressure (RDP) and Degree of Stenosis (DS) (Taylor Paragraphs [0308]-[0309] and [0314]-[0321] disclose determining a plaque vulnerability index calculated based on e.g. plaque strength and may use computed blood flow and pressure information as well as simulated blood pressure). Note the motivation to combine as used in the rejection of claim 2 is applicable. In regard to claim 5, Malota, in view of Taylor, teaches The method of claim 4, wherein the Reference Dynamic Pressure (RDP) expresses the ratio of the dynamic pressure in the stenosed model to the dynamic pressure in the reference model in the plaques region and the Degree of Stenosis (DS) is a coefficient that increases as a function of the degree of vessel constriction (Malota Pragraphs [0073]-[0078] disclose calculating energy using pressure values and comparing between the reference model and personalized model where the difference indicates the impact of lesions on the blood flow.). In regard to claim 6, Malota, in view of Taylor, discloses A computer-implemented system, comprising: at least one nontransitory processor-readable storage medium that stores at least one of processor-executable instructions or data; and at least one processor communicably coupled to at least one nontransitory processor- readable storage medium, wherein at least one processor is configured to perform the steps of the method of claim 1 (Malota Paragraph [0104] teaches the components of the system containing a non-transitory medium and executing computer instructions via a processor.) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The referenced claim is directed to determining a pressure force acting on a plaque surface utilizing a formula that incorporates tangent and normal components of force to the surface of a plaque at a point of action as well as the angle of the slope between the tangent curve at the pressure point and the main axis of the vessel. The closest prior art (Malota, in view of Taylor), teaches determining various factors related to risk of plaque rupture in blood vessels, but fails to disclose or render obvious the abovementioned combination of elements. Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Buckler U.S. Patent Publication No. 2021/0390689 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K MCINNISH whose telephone number is (571)270-1089. The examiner can normally be reached Monday - Friday 9 am - 6 pm (Flexible Fridays). 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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEVIN K MCINNISH/Primary Examiner, Art Unit 6221 Application/Control Number: 17/955,688 Page 2 Art Unit: 6221 Application/Control Number: 17/955,688 Page 3 Art Unit: 6221 Application/Control Number: 17/955,688 Page 4 Art Unit: 6221 Application/Control Number: 17/955,688 Page 6 Art Unit: 6221 Application/Control Number: 17/955,688 Page 7 Art Unit: 6221 Application/Control Number: 17/955,688 Page 8 Art Unit: 6221 Application/Control Number: 17/955,688 Page 9 Art Unit: 6221 Application/Control Number: 17/955,688 Page 10 Art Unit: 6221