Office Action Predictor
Application No. 17/244,479

CORONARY VEIN GUIDING SYSTEM AND ACCOMPANYING VEIN GUIDING METHOD AND SYSTEM

Final Rejection §101§103§112
Filed
Apr 29, 2021
Examiner
PORTILLO, JAIRO H
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Beijing Tuberculosis And Thoracic Tumor Research Institute
OA Round
2 (Final)
54%
Grant Probability
Moderate
3-4
OA Rounds
4y 6m
To Grant
94%
With Interview

Examiner Intelligence

54%
Career Allow Rate
179 granted / 333 resolved
Without
With
+39.7%
Interview Lift
avg trend
4y 6m
Avg Prosecution
43 pending
376
Total Applications
career history

Statute-Specific Performance

§101
20.7%
-19.3% vs TC avg
§103
46.7%
+6.7% vs TC avg
§102
9.3%
-30.7% vs TC avg
§112
21.0%
-19.0% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§101 §103 §112
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 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. Claim 1 and claims dependent thereon 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 pre-AIA the applicant regards as the invention. Claim 1 recites the limitation "the guide wire" in line 15. There is insufficient antecedent basis for this limitation in the claim. Regarding Claim 1, the term “adjusting an extension direction of the guide wire in the current segment in real time based on an actual extension direction of a previous segment of the accompanying vein” renders the claim indefinite because this limitation is introduced before a guide wire is delivered to the entrance position of the accompanying vein in S4. Thus, it is unclear if this intended to be 1) part of a description of operation before an accompanying vein segment is reached, 2) description of operation of a distinct guide wire from the guide wire in S4 and the intra-arterial guide wire in S6, or 3) is intended to be part of S4’s delivering step. Examiner believes the claim is following 3) above and suggests amending the claim in line with this interpretation, and further include in S4 how steps S1-S3 are followed for the totality of the segments in S4 until a target position is reached. 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 1, 4, and 7-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Regarding Claim 1, the claim(s) recites “S3: calculating an injection speed and a dosage of a contrast agent, so as to optimize a contrast agent injection plan and minimize an amount of the contrast agent to be used; wherein the step S3 further comprises dividing the estimated length into a plurality of segments and calculating the injection speed and the dosage of the contrast agent required for each of the segments, wherein in the step S3, the calculating further comprises… calculating the injection speed and the dosage of the contrast agent required for a current segment based on a length of the current segment and based on the blood flow velocity and blood pressure” which amounts to an abstract idea (mental process). This judicial exception is not integrated into a practical application because: - The claims fail to outline an improvement to the technical field. - The claims fail to apply the judicial exception to effect a particular treatment. - The claims fail to apply the judicial exception with a particular machine. - The claims fail to effect a transformation or reduction of a particular article to a different state or thing. Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered: “S1: acquiring position information of an occluded segment of an artery blood vessel;” “S2: obtaining an estimated length of an accompanying vein segment to be traversed based on the position information;” “acquiring a blood flow velocity and blood pressure in the accompanying vein;“ “S4: delivering a guide wire from an entrance position of the accompanying vein to a target position, accompanied by the injection of the contrast agent.” The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment. Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities. Furthermore, step S3’s adjusting of a guide wire based on extension in previous segments, step S4’s delivering a guidewire and injecting a contrast agent, S5’s delivering an intravascular ultrasound to the accompanying vein along the guide wire, and S6’s operating the intravascular ultrasound to guide an intra-arterial guide wire to travel in a true lumen in real time by intrasvascular ultrasound is not performed with any input from the mental processing in step S3 and thus those steps are just generic extrasolution activity as delivering a guidewire, adjusting a guidewire along its route, providing components along guide wire, injecting a contrast agent, and using intravascular ultrasound for guidance purposes are well-understood, routine, and conventional. Furthermore, guide wires and ultrasounds are general fields of use. None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of generally formulating a contrast agent injection plan with calculated injection speed and dosage of contrast agent and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 4 and 7-9 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above. Claim Rejections - 35 USC § 103 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. Claim(s) 1, 4, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogata et al (“Intravascular ultrasound-guided percutaneous coronary interventions with minimum contrast volume for prevention of the radiocontrast-induced nephropathy: report of two cases”) (“Ogata”) in view of Belef et al (US 6,475,226) (“Belef”) and further in view of Kalafut et al (US 2013/0253314) (“Kalafut”) and further in view of Keren (US 2009/0048497) and further in view of Schneider et al (US 2013/0131503) (“Schneider”) and further in view of Whiseant (US 2014/0180268). Regarding Claim 1, while Ogata teaches an accompanying vein guiding method (Abstract, p83), comprising following steps of: S1: acquiring position information of an occluded segment of an artery blood vessel (p84, Col. 1, Procedural outline – Diagnostic coronary angiography, where baseline coronary angiography was used to find position information of occlusion for Case 1, p84 “The baseline CAG was carried out with 18 cc of contrast dye, which showed a long diffuse narrowing of the proximal left anterior descending artery (LAD). The echocardiography showed that her LVEF was 78.1% (Fig. 2a).” and Case 2, p85 “He underwent a diagnostic CAG with 30 ml of contrast dye, with bi-plane projection. It showed that his right coronary artery (RCA) had a tight stenosis at the proximal portion and the left circumflex coronary artery (LCx) had a long diffuse stenosis.”); S3: minimizing an amount of the contrast agent to be used (p84, Col. 1, Procedural outline – PCI procedure, a final CAG performed at end of procedure using minimal contrast to judge effectiveness of procedure, Discussion, p85, 87, notes the reduction of contrast); and S4: delivering a guide wire from an entrance position of the artery to a target position, accompanied by the injection of the contrast agent (p84, Col. 1, Procedural outline – PCI procedure, delivery of coronary guidewire from an entrance position to a target position, accompanied by minimized injection of the contrast agent); and S5: delivering an intravascular ultrasound along the guide wire (p84, Col. Procedural outline, insertion of the IVUS catheter following the coronary guide wire, shown in Fig. 2b-2c). Ogata fails to teach S2: determining an accompanying vein segment to be traversed based on the position information; S4: delivering a guide wire from an entrance position of the accompanying vein to a target position, S5: delivering an intravascular ultrasound to the accompanying vein along the guide wire; and S6: operating the intravascular ultrasound to guide an intra-arterial guide wire to travel in a true lumen in real time by the intravascular ultrasound. However Belef teaches a percutaneous coronary intervention (Abstract, also known as PCI) comprising a percutaneous bypass surgery (Abstract) comprising following steps of: S1: having position information of an occluded segment of an artery blood vessel (Col. 6, L. 52 – Col. 7, L. 13, Col. 7, L. 62 – Col. 8, L. 31, PCI is described as providing an alternative path for oxygenated blood to flow around a restriction of an artery blood vessel by routing the blood through an accompany vein segment, guiding the catheter to the restriction requires the occluded segment’s position be known); S4: delivering a guide wire from an entrance of an accompanying vein to a target position (Col. 22, L. 25 – Col. 24, L. 57, teaches several details of an intravascular ultrasound based device, delivered from an entrance of an accompanying vein to act as a reference point to guide the tissue penetration from the artery blood vessel to the accompanying vein segment, where the ultrasound device itself may be in the form of a wire), S5: delivering an intravascular ultrasound to the accompanying vein as the guide wire (Figs. 23A-23B, Col. 24, L. 17-45, ultrasound guiding performed from the accompanying segment, where the intravascular ultrasound based device can be a guidewire in the accompanying vein); and S6: operating the intravascular ultrasound to guide an intra-arterial guide wire to travel in a true lumen by the intravascular ultrasound (Figs. 23A-23B, Col. 24, L. 17-45). Wherein a second embodiment teaches obtaining data of traversal of an accompanying vein segment (Col. 19, L. 57-65); Wherein a third embodiment teaches the application of contrast agents for guidance of bypass operation (Col. 17, L. 57 – Col. 18, L. 11); Where a fourth embodiment teaches delivering an intravascular ultrasound along a secondary device (Figs. 24A-24B, Col. 24, L. 46-65); and Wherein embodiment details may be incorporated into separate embodiments (Col. 17, L. 43-56). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the percutaneous coronary intervention teachings of Ogata to be applied to the percutaneous bypass intervention of Belef as this provides an example application of a specific well-known PCI method, involving an occluded artery and an accompanying vein segment, and Ogata explains how the ultrasound-based device of Belef in accompanying vein may be optimally guided – a feature unaddressed by Belef. Further, the use of ultrasound delivery and contrast agents is outlined for guidance in Belef, indicating the teachings of Ogata would be very relevant to one of ordinary skill in the art. Yet their combined efforts fail to teach S2: obtaining an estimated length of the accompanying vein segment to be traversed based on the position information; and S3: calculating an injection speed and a dosage of a contrast agent, so as to optimize a contrast agent injection plan and minimize an amount of the contrast agent to be used, wherein the step S3 further comprises dividing the estimated length into a plurality of segments and calculating the injection speed and the dosage of the contrast agent required for each of the segments, wherein in the step S3, the calculating further comprises acquiring a blood flow velocity and blood pressure in the accompanying vein; calculating the injection speed and the dosage of the contrast agent required for a current segment based on a length of the current segment and based on the blood flow velocity and blood pressure. However Kalafut teaches a method for providing optimized contrast agent for an imaging procedure (Abstract, [0081], [0169]) comprising S2: obtaining an estimated length of a vein segment to be traversed based on a targeted position information ([0072], [0075], [0079]-[0082] position of a second of region of interest is acquired as a target to perform an optimized contrast delivery, a volume to the target position is estimated based on a test bolus, where the estimated volume is representative of the length of the vein segment, an example vein segment could be the popliteal vein via the femoral artery); S3: calculating an injection speed and a dosage of a contrast agent ([0072], [0075], [0079]-[0082] optimized protocol generation for contrast delivery includes the parameters of flow rate and injection duration, [0166] where the delivered concentration of the contrast agent is also considered for the optimized delivery), so as to optimize a contrast agent injection plan and minimize an amount of the contrast agent to be used ([0080]-[0084], [0121]-[0123]), wherein the step S3 further comprises dividing the estimated length into a plurality of segments and calculating the injection speed and the dosage of the contrast agent required for each of the segments ([0081]-[0084], [0169]-[0170] where more than two regions of interest may be accounted for along the vein segment, the final region of interest being the desired target, and optimization of the contrast delivery is solved by the desired enhancement curve modeled at each region of interest. In setting a plurality of regions of interest along the volume of the vein segment and determining a final injection speed and dosage based on dynamics at each region of interest, one is essentially “dividing the estimated length into a plurality of segments and calculating the injection speed and the dosage of the contrast agent required for each of the segments”), wherein in the step S3, the calculating further comprises acquiring a blood flow velocity-related parameter and blood pressure-related parameter in the vein ([0072], [0075], [0079]-[0082] a blood volume between the contrast delivery site and the target location and a cardiac output of the patient is acquired in the vein segment); calculating the injection speed and the dosage of the contrast agent required for a current segment based on a length of the current segment and based on the blood flow velocity and blood pressure ([0072], [0075], [0079]-[0082] the injection speed and dosage of the contrast agent for a current segment leading up to the next region of interest is determined by volume and cardiac output, where a volume of the segment is based on the length of the segment, where a cardiac output of the patient can be considered a volumetric blood flow velocity, and a patient’s cardiac output is based on the patient’s blood pressure); It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the contrast optimization procedure of Ogata and Belef to comprise the above details of S3 as taught by Kalafut as these are detailed steps that are recognized to accomplish their desired minimization of contrast. Further, Kalafut states that these steps enable cardiovascular imaging through ultrasound ([0104]). Yet their combined efforts fail to teach wherein in the step S3, the calculating further comprises acquiring a blood flow velocity and blood pressure in the vein. However Keren teaches a medical device processing (Abstract) and teaches that it is known in the art that cardiac output can be found from either measurements of blood flow velocity or blood pressure ([0008]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to acquire blood flow velocity and blood pressure for the system of Ogata, Belef, and Kalafut as Keren teaches that these are parameters that can be used to find cardiac output. Finding cardiac output directly from these datasets reduces the amount of unknowns that that Kalafut must solve for and therefore simplifies Kalafut’s processing. Yet their combined efforts fail to teach adjusting an extension direction of the guide wire in the current segment in real time based on an actual extension direction of a previous segment of the accompanying vein; and However Schneider teaches that a radiological system for navigating a guidewire (Abstract, [0028]) can be performed using a real-time tracking of the guidewire using an electromagnetic sensor after an initial fluoroscopy imaging step ([0028]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the optimized contrast plan of Kalafut with the singular optimal contrast delivery act as the basis of the fluoroscopic image of Schneider as Kalafut ensures the initial fluoroscopic image is done with minimal harmful material while still outlining a path to the target position and Schneider real-time tracking takes maximal advantage of this contrast imaging to quickly deliver the guidewire to the desired location. Yet their combined efforts fail to teach S6: operating the intravascular ultrasound to guide an intra-arterial guide wire to travel in a true lumen in real time by the intravascular ultrasound. However Whiseant teaches a catheter steering operation (Abstract) comprising the use of real time travel guidance by the intravascular ultrasound to follow a true lumen ([0080]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the guidance of Ogata, Belef, Kalafut, and Keren in real time as taught by Whiseant to minimize delay in visualizing cardiac abnormalities for the healthcare provider. Regarding Claim 4, Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant teach the accompanying vein guiding method according to claim 1, wherein the target position is a distal end of the accompanying vein or a position in the accompanying vein corresponding to the occluded segment of the artery blood vessel (See Claim 1 Rejection, target position is a position in the accompanying vein corresponding to the occluded segment of the artery blood vessel). Regarding Claim 7, Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant teach the accompanying vein guiding method according to claim 1, wherein the artery is coronary artery, superficial femoral artery, internal carotid artery or renal artery; and the accompanying vein is coronary vein, superficial femoral vein, internal jugular vein or renal vein (See Claim 1 Rejection, Fig. 2, Col. 6, L. 52 – Col. 7, L. 13). Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogata in view of Belef and further in view of Kalafut and further in view of Keren and further in view of Schneider and further in view of Whiseant and further in view of Flaherty et al (US 6,375,615) (“Flaherty”). Regarding Claim 8, while Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant teach the accompanying vein guiding method according to claim 7, their combined efforts fail to teach wherein the coronary artery is anterior descending branch; the coronary vein is great cardiac vein; and the entrance position is at an ostium of coronary sinus. However Flaherty teaches a intravascular catheter with imaging (Abstract) where intravascular bypass surgery may be applied involving a coronary artery of the anterior descending branch; a coronary vein of the great cardiac vein; and an entrance position of the ostium of coronary sinus (Col. 12, L. 48 – Col. 13, L. 20). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the coronary artery and coronary vein bypass surgery of Belef specifically for a coronary artery of the anterior descending branch; a coronary vein of the great cardiac vein; and an entrance position of the ostium of coronary sinus as taught by Flaherty as a specific example of the anatomy both vulnerable occlusions and benefitted by bypass surgery. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogata in view of Belef and further in view of Kalafut and further in view of Keren and further in view of Schneider and further in view of Whiseant and further in view of Barron et al (US 2009/0149743) (“Barron”) and further in view of Ohishi (US 2018/0260998) and further in view of Fitzgerald et al (US 2005/0124969) (“Fitzgerald”) and further in view of Look et al (US 2017/0181760) (“Look”). Regarding Claim 9, while Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant teach the accompanying vein guiding method according to claim 1, a process of the injection of the contrast agent is associated with ON/OFF of a fluoroscopy device (See Claim 1 Rejection), their combined efforts fail to teach wherein the process of the injection of the contrast agent is associated with cardiac cycles, the injection of the contrast agent is controlled by means of cardiac cycle gating, blood pressure gating, or flow velocity gating, and the injection is implemented at a timing at which the blood flow velocity or blood pressure in the accompanying vein is the lowest so that the injection of the contrast agent and the cardiac cycle are synchronized with each other so as to reduce intraoperative radiation dose; and wherein the interaction signal comes from a voice from the user, or is a signal input from a mouse, a keyboard or a pedal. However Barron teaches a medical fluid injection system (Abstract) comprising X-ray fluoroscopy (Abstract, [0072]-[0073]) wherein the process of an injection of a contrast agent is associated with cardiac cycles, the injection of the contrast agent is controlled by means of cardiac cycle gating, blood pressure gating, or flow velocity gating, and the injection is implemented at a timing at which the blood flow velocity or blood pressure in the accompanying vein is the lowest so that the injection of the contrast agent and the cardiac cycle are synchronized with each other so as to reduce intraoperative radiation dose ([0103]-[0105]); and Wherein interaction signals with the system may be received from the user ([0107]-[0108] , [0135]) wherein input of the interaction signal comes from a pedal ([0138]); and teaches communicating system information with light ([0178]), It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the contrast injection based on cardiac cycle gating as taught by Barron to the contrast-based guidance system of Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant to reduce the usage of contrast, in line with the minimal contrast desired by the Ogata. Furthermore, it would be obvious to include a pedal-based interaction signal as taught by Barron with the systems of Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant to allow a user to make changes to the system’s functioning as needed during patient operation. Yet their combined efforts fail to teach before the injection, sound and light reminders are provided for the cardiac cycles, and a countdown reminder is performed for cardiac cycles selected for the injection, so as to remind a user to prepare for delivering the guide wire, and wherein selected cardiac cycles are N cardiac cycles after an interaction signal is received from the user, so that a start timing of performing a process of delivering the guide wire is determined by the user, where N is a natural number greater than or equal to 2. However Ohishi teaches a medical imaging system (Abstract) and teaches before the injection, a countdown reminder is performed for the time delay selected for the injection ([0052]) and Fitzgerald teaches a system for controlling contrast agent delivery (Abstract, [0078]-[0081]) wherein a delay in a contrast-related action can be performed on the basis of multiple cardiac cycles ([0083]-[0086] a delay in removal of contrast agent is done on the basis of N cardiac cycles after the delivery of the injection). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the contrast injection based on cardiac cycle gating as taught by Barron by a delay as taught by Ohishi as this allows a practitioner to prepare for delivery of the guidewire at an optimal timing as guided by the system. Further, it would be obvious to do so on the basis of N cardiac cycles as taught by Fitzgerald as it is a simple substitution of one form of judging a timing delay (Barron: time) for another (Fitzgerald: cardiac cycle number) to obtain predictable results of giving the user sufficient time to prepare. Further still, judging the delay by cardiac cycles is particularly relevant for a system controlled by a cardiac gating (Barron). Also, it would be obvious for the interaction signal of Barron to cause the delay timer of Ohishi and Fitzgerald to be started by user interaction signal as this ensures the practitioner believes contrast delivery may proceed while utilizing minimal amounts. Finally, it would be obvious to for the delay by cardiac cycles to be a natural number greater than or equal to 2 as Fitzgerald already outlines action delays at 3.5 cardiac cycles and thus would be a matter of routine optimization for the number of cardiac cycles that enables a practitioner to be ready to continue with the procedure [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)]. Yet their combined efforts fail to teach before the injection, sound and light reminders are provided for the cardiac cycles. However Look teaches an intravascular procedure device (Abstract, [0182] an embodiment of the aspiration device utilizes contrast and also notes the need to minimize contrast) wherein communication based on measured data includes sound and light communication ([0071]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to communicate the cardiac cycle data with light and sound reminders as taught by Look for the countdown of Ohishi and Fitzgerald to ensure the practitioner is maximally aware of the delay timing left for the start of contrast injection. Response to Arguments Applicant’s amendments and arguments filed 5/29/2025 with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. Applicant’s amendments and arguments filed 5/29/2025 with respect to the 35 USC 101 rejections have been fully considered but are not persuasive. Applicant argues that the claims recite several distinct practical applications beyond linking the use of a judicial exception to a particular technological environment. Applicant explains “Specifically, dividing the estimated length of the accompanying vein segment to be traversed into multiple segments enables the correct travel of the guide wire in the accompanying vein. The correct travel of the guide wire in the accompanying vein allows the intravascular ultrasound in the accompanying vein to guide the travel of the arterial guidewire in real time within the true lumen, thereby achieving the correct travel of the arterial guidewire. At the same time, dividing the estimated length into multiple segments and calculating the required contrast injection speed and dose for the current segment based on the length of the current segment, blood flow velocity, and blood pressure further minimizes contrast amount.” Examiner respectfully disagrees. As written, the travel of the guide wire is not related to the division of the vein segment, the injection of the contrast agent is not related to the optimized contrast agent injection plan, and the guided intra-arterial guide wire traveling in a true lumen is currently intended use and also not specifically stated as guidance to the occluded segment. The practical applications are thus not realized and the rejection stands. Applicant’s amendments and arguments filed 5/29/2025 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ogata, Belef, Kalafut, Keren, Schneider, and Whiseant. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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. /JAIRO H. PORTILLO/ Examiner Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Apr 29, 2021
Application Filed
Dec 28, 2024
Non-Final Rejection — §101, §103, §112
May 29, 2025
Response Filed
Sep 29, 2025
Final Rejection — §101, §103, §112
Apr 02, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
54%
Grant Probability
94%
With Interview (+39.7%)
4y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 333 resolved cases by this examiner