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 .
Information Disclosure Statement
The examiner found the Third Party Submission of February 10, 2016 in 14/643,088 (submitted by Aaron Johnson) particularly helpful because it detailed how much of the technology underlying the present specification was previously developed by Dr. Taylor. If Applicant has similar documents, the examiner would appreciate copies.
The information disclosure statement filed October 2, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
There are not copies of any of the foreign patent documents or non-patent literature publications.
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification refers to most of the ancestor applications as “divisionals,” however, these applications are not divisionals because they do not receive the benefit of 35 U.S.C. 121. One way to resolve this issue is to identify these ancestors as either continuations or continuations-in-part.
Additionally, the brief description of Fig. 2 is incorrect.
Appropriate correction is required.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Drawings
Figures 2 and 14-16 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Fig. 2 shows a heart (spec. p. 8) and Figs. 14-16 describe principles known in the prior art (see the brief descriptions).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
Claims 2-28 (all claims) are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of each of U.S. Patent No. US 9877657 B2, US 10667699 B2, US 11375904 B2, and US 12127816 B2 in view of the prior art as applied below.
Both the pending claims and the conflicting patents are all directed to modeling cardiac bloodflow for treatment. Therefore, all of the conflicting patents are directed to the same problem as the present application. Further, any differences between the present claims and the claims in any of the conflicting patents are obvious in view of the prior art as applied below. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to combine the below prior art with any of the conflicting patents for implementation details (especially as the patent claims lack implementation details). Based on the findings herein, this is an example of “(A) Combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
Present Claim 2
Claim 1 of US 12127816 B2
2. A computer-implemented coronary artery analyzing method, comprising:
acquiring a blood flow index corresponding to a pressure ratio between two points in a coronary artery, the blood flow index being obtained based on the coronary artery in three- dimensional volume data;
specifying an inappropriate bypass portion of the coronary artery, where forming a bypass connection is inappropriate, based on a three-dimensional image and the blood flow index, the three-dimensional image being rendered from the three-dimensional volume data;
writing, into a memory, a position distribution of the inappropriate bypass portion in a three-dimensional space, the position distribution being obtained based on the three- dimensional image and the blood flow index; and
causing a display to display a location of the specified inappropriate bypass portion together with a marker superimposed on the three-dimensional image based on the position distribution written into the memory, the specified inappropriate bypass portion being displayed in a distinguishable manner.
1. A computer-implemented method, comprising:
acquiring, based on a coronary artery in three-dimensional volume data, a distribution of a blood flow index corresponding to a pressure ratio between two points in the coronary artery;
specifying an inappropriate bypass portion of the coronary artery, where forming a bypass connection is inappropriate, based on information acquired based on the coronary artery in three-dimensional volume data, the information comprising an elasticity coefficient of a blood vessel wall of the coronary artery;
writing, into a memory, a position distribution of the inappropriate bypass portion in a three-dimensional space, the position distribution being obtained based on threshold processing of the elasticity coefficient of the blood vessel wall;
calculating a rendering pixel value for a two-dimensional or three-dimensional image based on the position distribution written into the memory;
generating the two-dimensional or three-dimensional image using the calculated rendering pixel value; and
causing a display to display a location of the specified inappropriate bypass portion together with a marker superimposed on the two-dimensional or three-dimensional image, the specified inappropriate bypass portion being displayed in a distinguishable manner,
wherein
the specifying comprises specifying, as the inappropriate bypass portion, a portion of the coronary artery where the elasticity coefficient of the blood vessel wall is higher than a first threshold and lower than a second threshold.
The conflicting patents are commonly owned as shown by the earlier terminal disclaimers in this family (e.g., in 15/837,632, the terminal disclaimer of December 30, 2019 states that U.S. Pat. 9,877,6557 is commonly owned). Further, all of the conflicting patents appear to share the same specification and set of drawings. Further, the reasoning in the earlier double patenting rejections applies here. Therefore, all of the conflicting patents are directed to the same invention as presently claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-28 (all claims) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2, 11, and 20 recite “display a location of the specified inappropriate bypass portion together with a marker superimposed on the three-dimensional image based on the position distribution written into the memory.” (Earlier in each of the claims, the position distribution is defined as being of the inappropriate bypass.) Applicant has not pointed out where the new claims are supported, nor does there appear to be a written description of these claim limitations in the application as filed. MPEP 2163.04(I)(B).
The most relevant disclosure in the specification is from p. 16:
The display 112 also displays a marker representing the connection position, which is generated by the marker generator 111 and superimposed on the three-dimensional image g4 or the two-dimensional image g5 derived from the volume data, as shown in, for example, FIG. 8.
Note that in FIG. 8, since the inner diameter of the blood vessel on the downstream side of the connection position is so thin (for example, 1.5 mm or less) as not to satisfy the criterion, this portion is determined as inappropriate to bypass and excluded from the color mapping display target.
Here, the specification teaches the (appropriate) bypass position should be shown via superimposition and the inappropriate bypass should not be. Note that the abstract also describes showing where the bypass should go rather than an inappropriate location.
Claims 2, 11, and 20 recite “blood flow index.” Applicant has not pointed out where the new claims are supported, nor does there appear to be a written description of these claim limitations in the application as filed. MPEP 2163.04(I)(B). Here, the phrase “blood flow index” does not appear in the specification (but fractional flow reserve does).
Claims 2, 11, and 20 recite “writ[e/ing], into the memory, a position distribution of the inappropriate bypass portion in a three-dimensional space.” Applicant has not pointed out where the new claims are supported, nor does there appear to be a written description of these claim limitations in the application as filed. MPEP 2163.04(I)(B). Here, the phrase “position distribution” does not appear in the specification.
Dependent claims are likewise rejected.
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 2-28 (all claims) 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 2, 11, and 20 recite “blood flow index,” but this is new terminology. MPEP 2173.05(a). The specification does not use the phrase “blood flow index.” Limiting the claim to the known term “fractional flow reserve” overcomes this rejection.
Claims 2, 11, and 20 each twice recite “being obtained based on,” but this phrase is unclear as to whether it requires a step of obtaining (i.e., adding an active step to the claim) or if it is defining how the obtaining occurred (i.e., a product-by-process limitation).
Dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-28 (all claims) are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by US20120041739A1 (“Taylor”).
Claim 1. (Canceled)
Claim 2. (New) A computer-implemented coronary artery analyzing method, comprising: (Taylor, claim 1, “1. A system for determining cardiovascular information for a patient, the system comprising: at least one computer system configured to:”)
acquiring a blood flow index corresponding to a pressure ratio between two points in a coronary artery, the blood flow index being obtained based on the coronary artery in three-dimensional volume data; (Taylor, claim 3, “the fractional flow reserve indicates a ratio between a pressure in the aorta and a pressure at a location in the plurality of coronary arteries;” and claim 1 “create a three-dimensional model representing at least a portion of the patient's heart.”)
specifying an inappropriate bypass portion of the coronary artery, where forming a bypass connection is inappropriate, based on a three-dimensional image and the blood flow index, the three-dimensional image being rendered from the three-dimensional volume data; (Taylor, [0233] “For example, the cFFR model 54 shown in FIGS. 1 and 23 indicates that … the lowest cFFR value in the RCA artery is 0.80. Treatment may be proposed if a cFFR value is, for example, less than 0.75.” the cFFR value being above the threshold for proposed treatments teaches the claimed inappropriate. Fig. 23 shows the claimed three dimensional image and blood flow index.)
writing, into a memory, a position distribution of the inappropriate bypass portion in a three-dimensional space, the position distribution being obtained based on the three- dimensional image and the blood flow index; and (Taylor, Fig. 23. See also Fig 1 and [0109] “The computer 40 may include a processor, … a random access memory (RAM)”))
causing a display to display a location of the specified inappropriate bypass portion together with a marker superimposed on the three-dimensional image based on the position distribution written into the memory, the specified inappropriate bypass portion being displayed in a distinguishable manner. (Taylor, Fig. 23. The black dots are super imposed, see e.g., https://www.merriam-webster.com/dictionary/superimpose - “to place or lay over or above something.” See also, Taylor, claim 19 “wherein the fractional flow reserve is indicated on the three-dimensional simulation using colors or shading, and changes in the fractional flow reserve are indicated by changes in color or shading.” Color and shading also teach the claimed superimposed.)
Claim 3. (New) The computer-implemented coronary artery analyzing method according to claim 2, wherein the three-dimensional volume data is of a patient of ischemic heart disease who is treated with coronary artery bypass grafting (CABG). (Taylor, [0231] “surgery on any portion of the modeled anatomy or other portions of the heart (e.g., coronary artery bypass grafting.”)
Claim 4. (New) The computer-implemented coronary artery analyzing method according to claim 2, wherein the causing comprises causing the display to display the location of the specified inappropriate bypass portion together with the marker superimposed on the three-dimensional image, as well as display the blood flow index. (Taylor, Fig. 23)
Claim 5. (New) The computer-implemented coronary artery analyzing method according to claim 2, further comprising acquiring the blood flow index through computer simulation. (Taylor, claim 1, “determine a fractional flow reserve within the patient's heart based on the three-dimensional model and the physics-based model.”)
Claim 6. (New) The computer-implemented coronary artery analyzing method according to claim 2, wherein the three-dimensional image comprises a CT image of the coronary artery, and the causing comprises causing the display to display the location of the specified inappropriate bypass portion in a state superimposed on the CT image. (Taylor, claim 5, “5. The system of claim 4, wherein the imaging data is provided by computer tomography or magnetic resonance imaging techniques.”)
Claim 7. (New) The computer-implemented coronary artery analyzing method according to claim 2, wherein the three-dimensional image comprises an image of the coronary artery, and the causing comprises causing the display to display the location of the specified inappropriate bypass portion together with the image of the coronary artery in such a manner that a reason why the inappropriate bypass portion is inappropriate for the bypass connection is distinguishable. (Taylor, Fig. 23. The black dots are super imposed, see e.g., https://www.merriam-webster.com/dictionary/superimpose - “to place or lay over or above something.” Fig. 23’s cFFR values teach the claimed distinguishable reason.)
Claim 8. (New) The computer-implemented coronary artery analyzing method according to claim 2, further comprising, in response to receiving an input for selecting a bypass portion at a display of the three-dimensional image of the coronary artery, (Taylor, [0269] “The reduced order model may also be incorporated into an angiography system to allow for live computation of treatment options while a physician examines a patient in a cardiac catheterization lab. …”)
updating the display by rotating the three-dimensional image of the coronary artery. (Taylor, [0269] “… The model may be registered to the same orientation as the angiography display.” Taylor’s registering to an orientation teaches the claimed rotating because registering is being used in the sense of “8: a condition of correct alignment or proper relative position.” https://www.merriam-webster.com/dictionary/registering)
Claim 9. (New) The computer-implemented coronary artery analyzing method according to claim 2, wherein the three-dimensional image comprises an image of the coronary artery, and the method comprises: determining a bypass portion based on the blood flow index; and (Taylor, [0231] “As described above, the cFFR model 54 shown in FIGS. 1 and 23 indicates the cFFR values throughout the patient's anatomy represented by the mesh 380 of FIGS. 17-19 in an untreated state and under simulated hyperemia conditions. Using this information, the physician may prescribe treatments to the patient, such as an increase in exercise, a change in diet, a prescription of medication, surgery on any portion of the modeled anatomy or other portions of the heart (e.g., coronary artery bypass grafting”)
causing the display to display the bypass portion on the image of the coronary artery. (Taylor, [0238] “For example, coronary artery bypass grafting may involve creating new lumens or passageways in the solid model 320”)
Claim 10. (New) The computer-implemented coronary artery analyzing method according to claim 9, wherein the determining comprises determining the bypass portion to be on a downstream side of a stenosis. (Taylor, [0206] “For example, the functionally significant lesion(s) may be located by finding a narrowing or stenosis located near (e.g., upstream) from the location of the cFFR model 54 having the local minimum cFFR value.” The stenosis being located upstream teaches the claimed bypass being downstream of the stenosis.)
Claims 11-28 are rejected as per their counterpart claims. Additionally, Taylor claim 5 teaches “A non-transitory computer-readable storage medium” and Taylor claim 9 teaches “A device, comprising: processing circuitry configured to … .” See also, Taylor, Fig. 1, computer 40.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120072190 A1 – title, “Method And System For Non-Invasive Assessment Of Coronary Artery Disease”
US 20140046642 A1 – similar to the presently applied reference, but has more detail on the user interface, but less about the underlying modeling
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID ORANGE whose telephone number is (571)270-1799. The examiner can normally be reached Mon-Fri, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached at 571-272-3838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID ORANGE/ Primary Examiner, Art Unit 2663
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