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 1-20 are pending and under examination.
Claims 1-20 are rejected.
Claim 8 is objected to.
Claim 1 is independent.
No claims are allowed, amended, canceled, new, or withdrawn.
Office Action Outline
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In the Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 06/28/2023 filing receipt, this application claims priority to U.S. Provisional Application 63/349,807, filed 06/07/2022.
However, claims 1-20 are being examined with an effective filing date of 06/06/2023, the filing date of the instant invention. This is because the claims recite limitations which are not supported by the disclosure of provisional application 63/349,807.
As examples, the claims at least recite the following unsupported limitations:
• obtaining a first MRI of the heart (independent claim 1)
• generating a simulation of flow patterns (claims 1 and 4)
• simulating blood flow in the heart (claim 1 and 5)
• selecting the shunt device that complements the flow patterns (claims 1 and 6)
• obtaining a 4D MRI of the heart (claim 2, 3, 16, and 17)
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites "the tissue wall in which the shunt device is implant that complements," which should be corrected to "the tissue wall in which the shunt device is implanted that complements." Appropriate correction is required.
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 1-20 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 depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
In claim 1, the relationship is unclear between the “obtaining a first MRI of the heart” and the other steps of the claim, as no subsequent step in claim 1 is linked to the obtained first MRI. It is additionally noted that all other steps of claim 1 (the generating, simulating, selecting, and implanting steps) have uncertain relationships between themselves, in that there is a general and/or specific disconnect between all steps.
An example of general disconnect includes: In claim 1, it is not clear if the generating step is intended to be based on the first MRI.
An example of specific disconnect includes: In claim 1, the relationship is unclear between the “flow patterns” (in the generating step) and the “flow patterns” (in the selecting step), in that it is not clear if the selecting step is referring to the flow patterns which are simulated in the generating step, or to actual flow patterns of the heart.
If it is Applicant’s intention that the generating a simulation step be based on the first MRI, and that the subsequent steps be based on previous steps, then it is suggested to amend claim 1 to appropriately reflect this intention.
The "simulating blood flow" element of claim 5 is unclear in that at least the first of three sub-elements is not clearly separated from the rest of the element, in reciting: "simulating blood flow in the heart when the shunt devices having varying cross sectional areas of a flow path of the shunt device, varying angles of central flow tubes of the shunt devices with respect..."
The rejection might be overcome by possibly amending claim 5 to number the sub-elements as follows: "simulating blood flow in the heart when the shunt devices having (i) varying cross-sectional areas of a flow path of the shunt device, (ii) varying angles of central flow tubes of the shunt devices with respect to a tissue wall in which the shunt devices are implanted, and/or (iii) varying placement of the shunt devices along a coronary sinus are implanted in the heart." Claim 5 will be interpreted as suggested to amend.
Claim 5 first recites "the shunt devices" in the recitation "simulating blood flow in the heart when the shunt devices having..." This instance of "the shunt devices" requires but lack clear antecedent. If "the shunt devices" refers to the previously instantiated "various shunt devices," then possibly amending the five recitations of "the shunt devices" in claim 5 to recite "the various shunt devices" might overcome the rejection. Alternatively, this rejection might be overcome by amending claim 5 to delete "the" from the first instance of "the shunt devices."
Claim 17, which depends from claim 15, recites “the 4D MRI,” which requires but lacks clear antecedent. It is noted claim 16 recites “a 4D MRI.” Amending claim 17 to depend from claim 16 would likely overcome the rejection. Claim 17 will be interpreted as suggested to amend.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP §§ 2106.04(a), 2106.04(a)(2), and 2106.04(b)).
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 1-20 are directed to a 101 process, here a method, which falls under a category of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 2A, Prong One:
The claims are found to recite abstract ideas in the form of mental processes (and mathematical concepts, where indicated), as follows:
Independent claim 1 recites mental processes of:
• generating a simulation of flow patterns of blood flow in the heart
• simulating blood flow in the heart when various shunt devices are implanted in the heart
• selecting the shunt device that complements the flow patterns of blood flow in the heart
Claim 19 recites a mental process of:
• comparing one or more of the measures (of heart anatomy and/or physiology, listed in claim 19) between the first MRI and the second MRI
Claims 4 and 5 further limit the simulating blood flow of claim 1.
Claims 6-14 further limit the selecting of the shunt device of claim 1.
Step 2A Prong One Summary: The claims recite mental processes. When considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claim 1 (e.g., generating a simulation of flow patterns; simulating blood flow in the heart when various shunt devices are implanted in the heart; and selecting the shunt device) are directed to processes that may be performed in the human mind, or with pen and paper, as there are no particular limitations recited in claim 1 which would prevent the mental processes from being performed in the human mind or with pen and paper. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s) and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see 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.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Obtaining an MRI or 4D MRI of the heart (claims 1-3 and 15-18) recite the additional elements of inputting or obtaining data. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology (see MPEP § 2106.04(d)(I)).
Additional element of therapy (surgery): Implanting the shunt device to the heart (claim 1). The additional element of implanting the shunt device does not integrate the judicial exception (JE; here, abstract ideas) into a practical application. This is because while the shunt device (which is implanted in the last step of claim 1) is selected in the selecting step, the implanting step has only an insignificant relationship to the selecting step, to the simulating step, and to the generating step. As such, the additional element of implanting the shunt device has only an insignificant relationship to the abstract ideas. Further, the generating, simulating, and selecting steps are not based on, nor linked in any way, to the first MRI of the heart. Therefore, the JE is not integrated into a practical application at Step 2A Prong Two of the 101 analysis. (See MPEP § 2106.04(d)(2).)
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. (Step 2A, Prong Two: No). (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the JE (here, abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of obtaining an MRI or 4D MRI of the heart (claims 1-3 and 15-18) do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; and storing and retrieving information in memory, etc. [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additionally, the obtaining of an MRI or 4D MRI of the heart is shown to be conventional by the following reference(s):
Geiger (Pediatric Radiology, vol. 51(8), pp.1503-1517 (2021); cited on the attached form PTO-892) presents a review on use of 4D MRI in congenital heart disease (entire document).
Additional element of therapy (surgery): Implanting the shunt device to the heart (claim 1) does not cause the claims to rise to the level of significantly more than the judicial exception, and as such do not provide an inventive concept. Implanting a shunt device to the heart is a well-known, understood, and conventional surgical procedure, as shown by the following reference:
Miyagi (Heart failure reviews, vol. 26(4), pp.749-762 (2021); cited on the attached form PTO-892) presents a review on device‑based treatment options for heart failure with preserved
ejection fraction and shows a section discussing interatrial shunt devices (p.751 -752).
All limitations of claims 1-20 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. Step2B: NO.
Therefore, the claims, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non-patent eligible subject matter.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eigler (US 2018/0243071 A1, published 08/30/2018; cited on the attached form PTO-892), in view of Geiger (Pediatric Radiology, vol. 51(8), pp.1503-1517 (2021); cited on the attached form PTO-892), in view of Hellmeier (Artificial organs, vol. 42(1), pp.49-57 (2018); cited on the attached form PTO-892).
In claim 1, the recited simulating blood flow in the heart when various shunt devices are implanted in the heart reads on “These measured data and simulations show that the valveless lumen of the hourglass shaped V-Wave Nitzan-type shunt is more efficient at supporting bulk flow over the expected physiological range of pressure gradients than an orifice - plate shunt” (Eigler, [0143]).
In claim 1, the recited selecting the shunt device that complements the flow patterns of blood flow in the heart reads on “In accordance with the principles of the present invention, the radial dimensions, axial lengths and contours of neck region 16 and flared end regions 14 and 18 preferably are selected to provide laminar flow through the interior of the shunt, to reduce the formation of eddy currents when implanted, and thus inhibit thrombus formation; to inhibit pannus formation that could obstruct the neck region; to promote tissue ingrowth around the exterior of the neck region to secure the shunt against migration; to provide a desired rate of blood flow between the left and right atria at physiological pressure differentials; and to prevent retrograde paradoxical embolization.” (Eigler, [0100]).
In claim 1, the recited implanting the shunt device in the heart reads on “FIGS. 8A and 9A depict positioning of the shunts immediately post implantation” (Eigler, [0124]).
In claim 5, the recited simulating blood flow in the heart when the shunt devices having varying cross-sectional areas of a flow path of the shunt device, varying angles of central flow tubes of the shunt devices, and/or varying placement of the shunt devices along a coronary sinus are implanted in the heart reads on “shown in FIG. 17, is the simulated flow for venturi tubes with orifice inner diameters of 5.1 and 6 mm with discharge coefficients of 0.97 and 0.96 respectively...Simulations of a conical convergent nozzle...with a convergence angle of 37 and 36 degrees and a discharge coefficient of 0.92 for the 5.1 and 6 mm orifice inner diameters, respectively, showed similar predictive accuracy with actual shunts.” (Eigler, [0142]).
In claim 6, the recited selecting a design of the shunt device that complements the flow patterns of blood flow in the heart reads on “Interatrial shunts are provided for redistributing interatrial blood volumes and reducing left atrial pressure, which may be advantageous in treating subjects suffering from heart failure (HF) or other disorders associated with elevated left atrial pressure. A preferred embodiment of the inventive device includes an anchor, which may be an hourglass or “diabolo" shaped stent or frame, and a conduit, formed by encapsulating the frame in a synthetic biocompatible material. The shunt is configured to be lodged securely within a passage formed in the atrial septum, preferably the fossa ovalis, and provides one-way blood flow from the left atrium to the right atrium, when blood pressure in the left atrium exceeds that on the right (Eigler, [0095]), and “In a preferred embodiment of shunt 10, the volume of blood displaced by the portion of the shunt protruding into the LA (left atrium)...should be less than or equal to 5% of the LA diastolic volume expected in the patient population” (Eigler, [0129]); and “Similar considerations exist for the RA (right atrium) side of the FO (fossa ovalis). The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]).
In claim 7, the recited selecting a cross-sectional area of a flow path of the shunt device that complements the flow patterns of blood flow in the heart reads on “neck region 16 may have a diameter suitable for implantation in the fossa ovalis, e.g., that is smaller than the fossa ovalis, and that also is selected to inhibit blood flow rates exceeding a predetermined threshold” (Eigler, [0120]). While Eigler uses varying orifice diameters in simulating blood flow, it would be obvious to use a related measurement such as cross-sectional area in the cardiac blood flow simulations.
In claim 8, the recited selecting an angle of a central flow tube of the shunt device with respect to the tissue wall in which the shunt device is implant that complements the flow patterns of blood flow in the heart. reads on “Simulations of a conical convergent nozzle...with a convergence angle of 37 and 36 degrees and a discharge coefficient of 0.92 for the 5.1- and 6-mm orifice inner diameters, respectively, showed similar predictive accuracy with actual shunts.” (Eigler, [0142]).
In claim 9, the recited selecting the design of the shunt device that complements a right-sided flow vortex in a right atrium of the heart. reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); and “blood entering the RA (right atrium) from the IVC (inferior vena cava) forms a clockwise vortex... in most patients with normal anatomy. Advantageously, this flow pattern...reduces the risk of blood pooling in the vicinity of neck region 16 of the inventive shunt 10, thus reducing the risk of local thrombus formation due to blood stasis” (Eigler, [0132]).
In claim 10, the recited selecting a placement of the shunt device along a coronary sinus that complements the flow patterns of blood flow in the heart reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); and “The more cylindrical shape of flared end region 14 further may reduce or inhibit contact between flared end region 14 , and the right side of atrial septum 70 , as well as ridge 77 separating the coronary sinus from the IVC 74” (Eigler, [0117]).
In claim 11, the recited selecting a placement of the shunt device along the coronary sinus that complements a right-sided flow vortex in a right atrium of the heart reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); and “blood entering the RA (right atrium) from the IVC (inferior vena cava) forms a clockwise vortex... in most patients with normal anatomy. Advantageously, this flow pattern...reduces the risk of blood pooling in the vicinity of neck region 16 of the inventive shunt 10, thus reducing the risk of local thrombus formation due to blood stasis” (Eigler, [0132]); and “The more cylindrical shape of flared end region 14 further may reduce or inhibit contact between flared end region 14 , and the right side of atrial septum 70 , as well as ridge 77 separating the coronary sinus from the IVC 74” (Eigler, [0117]).
In claim 12, the recited selecting the shunt device that complements a right-sided flow vortex in a right atrium of the heart, a left-sided flow vortex in a left atrium of the heart, and/or a helical flow pattern of blood flow in a coronary sinus of the heart reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); and “The more cylindrical shape of flared end region 14 further may reduce or inhibit contact between flared end region 14 , and the right side of atrial septum 70 , as well as ridge 77 separating the coronary sinus from the IVC 74” (Eigler, [0117]).
In claim 13, the recited selecting a design of the shunt device and a placement of the shunt device along a coronary sinus that enhances a right-sided flow vortex of blood flow in a right atrium of the heart reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); “blood entering the RA (right atrium) from the IVC (inferior vena cava) forms a clockwise vortex... in most patients with normal anatomy. Advantageously, this flow pattern...reduces the risk of blood pooling in the vicinity of neck region 16 of the inventive shunt 10, thus reducing the risk of local thrombus formation due to blood stasis” (Eigler, [0132]); and “The more cylindrical shape of flared end region 14 further may reduce or inhibit contact between flared end region 14 , and the right side of atrial septum 70 , as well as ridge 77 separating the coronary sinus from the IVC 74” (Eigler, [0117]).
In claim 14 the recited selecting a design of the shunt device and a placement of the shunt device along a coronary sinus that reestablishes a right-sided flow vortex of blood flow in a right atrium of the heart reads on “The shunt should occupy a minimal volume and have only a small effect on normal flow patterns (Eigler, [0130]); “blood entering the RA (right atrium) from the IVC (inferior vena cava) forms a clockwise vortex... in most patients with normal anatomy. Advantageously, this flow pattern...reduces the risk of blood pooling in the vicinity of neck region 16 of the inventive shunt 10, thus reducing the risk of local thrombus formation due to blood stasis” (Eigler, [0132]); and “The more cylindrical shape of flared end region 14 further may reduce or inhibit contact between flared end region 14 , and the right side of atrial septum 70 , as well as ridge 77 separating the coronary sinus from the IVC 74” (Eigler, [0117]).
In claim 20, the recited adjusting the shunt device reads on “shunt 30 may be positioned and repositioned in a passage formed in the interatrial septum until the clinician is satisfied with the device placement” (Eigler, [0108]).
While Eigler [0131] mentions “magnetic resonance velocity mapping,” Eigler does not specifically disclose a first MRI of the heart (claim 1) or a 4D MRI of the heart (claim 2) (shown by Geiger).
While Eigler [0142-0143] discloses simulations of blood flow for devices of different sizes, Eigler does not specifically show generating a simulation of flow patterns of blood flow in the heart (i.e., without the devices) of claim 1 (shown by Hellmeier).
Eigler does not show a 4D MRI to visualize flow patterns of the right atrium, left atrium, and/or coronary sinus of claim 3 (shown by Geiger).
Eigler does not show generating a simulation of the flow patterns of blood flow in a right atrium, a left atrium, and/or a coronary sinus of claim 4 (shown by Geiger).
While Eigler discusses follow-up imaging studies [0042], Eigler does not specifically disclose comparing measurements from a second MRI of claims 15-19 (shown by Geiger).
In claim 1, the recited obtaining a first MRI of the heart reads on the section titled “Four-dimensional flow magnetic resonance imaging - acquisition” (Geiger, bridging p.1505-1506); and “We usually perform the 4-D flow acquisition in axial orientation covering the complete heart and the aortic arch” (Geiger, p.1506, col.1, ¶ 5).
In claim 1, the recited generating a simulation of flow patterns of blood flow in the heart reads on “This study investigated the hemodynamic impact of different prostheses through patient-specific MRI-based CFD simulations.” (Hellmeier, p.1, abstract.)
In claim 2, the recited obtaining a 4D MRI of the heart reads on “We usually perform the 4-D flow acquisition in axial orientation covering the complete heart and the aortic arch” (Geiger, p.1506, col.1, ¶ 5).
In claim 3, the recited obtaining a 4D MRI of the heart to visualize the flow patterns of blood flow in a right atrium, a left atrium, and/or a coronary sinus of the heart reads on “4-D flow-based colour-coded pathline tracking demonstrate the abnormal flow of right (RPV, red) and left (LPV, orange) pulmonary veins entering the right atrium (RA) inferiorly via the coronary sinus (CS). Blood from the inferior caval vein (IVC) flows directly to the left atrium (LA) via an associated atrial septal defect” (Geiger, p.1509, fig. 6).
In claim 4, the recited generating a simulation of the flow patterns of blood flow in a right atrium, a left atrium, and/or a coronary sinus of the heart reads on “4-D flow-based colour-coded pathline tracking demonstrate the abnormal flow of right (RPV, red) and left (LPV, orange) pulmonary veins entering the right atrium (RA) inferiorly via the coronary sinus (CS). Blood from the inferior caval vein (IVC) flows directly to the left atrium (LA) via an associated atrial septal defect” (Geiger, p.1509, fig. 6).
In claim 15, the recited obtaining a second MRI of the heart reads on “assess the course of the disease by performing follow-up scans” (Geiger, p.1504, col.1, ¶ 1).
In claim 16, the recited obtaining a 4D MRI of the heart to visualize the flow patterns of blood flow in the heart. reads on “We usually perform the 4-D flow acquisition in axial orientation covering the complete heart and the aortic arch” (Geiger, p.1506, col.1, ¶ 5).
In claim 17, the recited obtaining the 4D MRI of the heart to visualize the flow patterns of blood flow in a right atrium, a left atrium, and/or a coronary sinus of the heart. reads on “4-D flow-based colour-coded pathline tracking demonstrates the abnormal flow of right (RPV, red) and left (LPV, orange) pulmonary veins entering the right atrium (RA) inferiorly via the coronary sinus (CS). Blood from the inferior caval vein (IVC) flows directly to the left atrium (LA) via an associated atrial septal defect” (Geiger, p.1509, fig. 6).
In claim 18, the recited obtaining the first MRI and the second MRI comprises measuring one or more of the listed measurements reads on “Four-dimensional flow pathline tracking analysis demonstrates that right ventricular stroke volume is divided into the pulmonary arteries and the Dao (descending aorta) somewhat equally (c), whereas most of the left ventricular stroke volume goes into the head and neck vessels” (Geiger, p.1512, Fig.10c and d); and “assess the course of the disease by performing follow-up scans” (Geiger, p.1504, col.1, ¶ 1).
In claim 19, the recited comparing one or more measurements from the first MRI with measurements from the second MRI reads on “assess the course of the disease by performing follow-up scans” (Geiger, p.1504, col.1, ¶ 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for implanting of, selecting of, and simulating with interatrial shunt devices of Eigler to include the first and second MRI, and 4D MRIs, in visualizing flow patterns of Geiger, with the generation of blood flow simulation of the heart of Hellmeier. This is because a PHOSITA would have had a reasonable expectation of success in doing so because Geiger states 4D MRI flow imaging has the potential to improve individualized management and become indispensable for individual risk stratification; and, while Hellmeier focuses on the aortic valve, Hellmeier discloses the general point that use of blood flow simulations could contribute to personalized decision making, reduce complications and improve patient care. Thus, it would have been obvious to modify Eigler with Geiger and Hellmeier, and as such, the combination would have been obvious.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith A Vassell whose telephone number is (571)272-1771. The examiner can normally be reached 8:30 - 4:30.
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/M.A.V./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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