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 .
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive. Applicant argues that the prior art fails to disclose the particular arrangement recited in claim 1 of the distal location of a distal sensor being in an abnormality cavity that is formed between an abnormality wall and the deployed stent graft within the abnormality cavity. As annotated below in the rejection, the location of the sensor disclosed by Inoue meets this requirement. The stent graft is located within an abnormality, and the distal sensor is located inside an abnormality cavity that is defined by the wall of the abnormality and the deployed stent graft. Although the arrangement is not exactly the same as pictured in Figure 1B of Applicant’s disclosure, the Examiner notes that the claim does not specify that the distal sensor is located along the outer wall of the stent graft.
In regards to claim 12, applicant argues that the nosecone (304) of Steenwyk is not a catheter. The Examiner acknowledges this and has clarified the description of the embodiment of Figure 8. Steenwyk discloses a first nested catheter (delivery sheath 312) moveably disposed within a second nested catheter (308). A distal sensor (302) is integrated with the first catheter (312) (see location of distal sensor 302 on nosecone that is located adjacent the distal end of the first catheter (312). A proximal sensor (306) is integrated with the second catheter (304). Since the first nested catheter (delivery sheath 312) is relatively moveable to the second nested catheter (308), the two sensors are also moveable relative to one another [0067]. Therefore, this rejection has been maintained.
Claim 16 is rejected with a new combination of Steenwyk and Inoue in light of the amendments.
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 9 and 10 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.
Claim 9 requires deploying the ancillary device within the deployed stent graft. This limitation contradicts claim 1, which sets forth a location of a sensor between the stent-graft and abnormality wall, which is shown in Figure 1B. In this embodiment, the ancillary device is not within the stent-graft, but positioned along an outer surface of the stent-graft. Therefore, the originally filed specification lacks sufficient support for the combination of limitations in claim 9.
Claim 10 requires the distal location to be distal of the distal end of the stent, graft, which appears to contradict the distal location set forth in claim 1. The originally filed specification appears to lack sufficient support for the combination of limitations.
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 9 and 10 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. Since claims 9 and 10 have contradictory limitations, the scope of the claims is rendered indefinite.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1-3, 7, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2019/0336135 (Inouye et al.).
Regarding claim 1: Inouye discloses a method for determining a pressure gradient between proximal and distal locations within a vasculature of a patient, the method comprising:
deploying an ancillary device (34) within the vasculature (the heart is considered to be part of vasculature), the ancillary device integrating a proximal sensor (30) at the proximal location and a distal sensor (32) at the distal location [0074; 0087];
deploying, via a stent graft delivery system (see delivery system 24 in Figure 2; [0062]), a stent graft (10) (occlusive implant 10 includes a stent framework 12 [0055] and covering 14 [0057-0058] and therefore meets the requirements of a stent-graft) within the vasculature to obtain a deployed stent graft [0086]), the ancillary device (34) independent from the stent graft delivery system (24) and the stent graft (10);
outputting proximal pressure data from the proximal sensor and indicative of pressure at the proximal location and distal pressure data from the distal sensor and indicative of pressure at the distal location (see description of measuring pressure at [0074];
and determining the pressure gradient using the proximal and distal pressure data (see description of comparing a first fluid pressure to a second fluid pressure [0075; 0077]).
The distal location (where the distal sensor 32 is placed) is within an abnormality cavity (see placement of distal sensor 32 in cavity 50), the abnormality cavity being formed between an abnormality wall (52) and the deployed stent graft (10) within the abnormality (left atrial appendage 50). The proximal location is located outside the abnormality cavity (see proximal sensor 30 outside the cavity 50) (See Fig. 7; [0086-0087].
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Regarding claim 2: the ancillary device (34) is situated outside the deployed stent graft (10) while the outputting step is performed (see Fig. 7; [0086]).
Regarding claim 3, Inouye discloses the pressure gradient is calculated after deployment of the stent graft (10) (see description of detection of leakage after deployment of implant 10 [0075-0077]). This meets the requirement of the outputting step performed during a monitoring period relative to a completion of the second deploying step.
Regarding claim 7, the proximal location is located outside the abnormality cavity (see proximal sensor 30 outside the cavity 50) (See Fig. 7; [0086-0087].
Regarding claim 9, the first deploying step (deploying the ancillary device 34) includes deploying the ancillary device within the deployed stent graft (10) (See Fig. 6; [0084-0085]).
Regarding claim 10, the distal sensor (32) is placed distally relative to the stent graft and the proximal sensor (30) is placed proximally of the stent graft (see Fig. 6; [0084-0085]).
Regarding claim 11, since the pressure values are compared, it is understood the outputting step includes simultaneous measurement of proximal and distal pressures [0074-0076].
Claim(s) 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by USPAP 2024/0033080 (Steenwyk et al.).
Regarding claim 12: Steenwyk discloses a method for determining a pressure gradient between proximal and distal locations within a vasculature of a patient [0081], the method comprising:
deploying a guidewire (310) within the vasculature;
deploying first and second nested catheters (308 and 312) over the guidewire (310) within the vasculature, the first nested catheter (delivery sheath 312) integrating a distal sensor (302) at the distal location (via nosecone 304), and the second nested catheter (308) integrating a proximal sensor (306) at the proximal location (see Fig. 8; [0067]);
deploying a stent graft (314) within the vasculature to obtain a deployed stent graft;
outputting proximal pressure data from the proximal sensor and indicative of pressure at the proximal location and distal pressure data from the distal sensor and indicative of pressure at the distal location [0068];
and determining the pressure gradient using the proximal and distal pressure data [0050; 0068; 0081].
Regarding claim 13, wherein the first nested catheter (304) has an outer diameter less than or equal to an inner diameter of the second nested catheter (308), and the second deploying step including first deploying the first nested catheter and secondly deploying the second nested catheter (see description of positioning the catheters 304 and 308 separately).
Regarding claim 14, wherein a distal end of the second nested catheter (308) is located proximal a distal end portion of the first nested catheter (304) (see Fig. 8).
Regarding claim 15, the distal end portion of the first nested catheter (304) integrates the distal sensor (302) (see Fig. 8; [0068]).
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) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over in Inoue view of US 9,314,584 (Riley et al.), and further in view of USPAP 2024/0033080 (Steenwyk et al.)
Inoue fails to disclose the proximal sensor on a guidewire and the distal sensor on a catheter. Although Inoue only illustrates that the pressure gradient is measured at the site of an atrial appendage, Inoue teaches the method can be performed at a different location in the body at the site of a different types of implant, such as implants with a frame and fabric for treatment of aneurysms [0112], wherein it is understood that aneurysms form sacs or cavities.
Riley discloses another method of measuring a pressure gradient in vasculature. Riley discloses that it is advantageous to measure a pressure gradient at the site of an implant delivered to treat an abnormality, such as a stenosis in a vessel to provide enhanced knowledge of thrombus and stent restenosis (col 14, lines 28-56). As shown in Fig. 28-29, an ancillary device (carrier 100) having sensors is placed at the site of both a stent (110) and stenosis (S). one of ordinary skill in the art would have therefore found it obvious to perform the Inoue method at the site of an implant where a stent-graft is placed to treat an abnormality, such as an aneurysm defining a cavity, as Riley teaches that this provides a provides information related to the performance of the implant and health of the patient.
Inoue and Riley fail to disclose the proximal and distal sensors placed on separate catheter and guidewire components. Steenwyk teaches that two sensors of an apparatus for measuring pressure gradient in vasculature can be placed on separate components instead of the same component (see wire 110 in Figure 6). An embodiment in Figure 9 discloses an ancillary guidewire (208) integrating a first sensor (216) and an ancillary catheter (202) a second sensor (218), and the ancillary catheter is movable relative to the ancillary guidewire [0070; 0074-0075]. Therefore, the apparatus of Figure 9 can be positioned such that the guidewire (208) includes the proximal sensor and the catheter (202) includes the distal sensor. In light of Steenwyk’s disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Inoue method such that the two sensors are located on separate guidewire and catheter components to allow for their relative positioning.
Steenwyk discloses the proximal and distal arrangement of the sensors can be switched relative to the particular implant being measured (see [0065; 0076]). It would have therefore been obvious to place the proximal sensor on the guidewire and the distal sensor on the catheter, according to the particular location of the vasculature implant being evaluated.
Further in regards to claim 4: Inoue teaches the pressure sensing device (26) positioned along the outer wall of a stent graft (14) such that it is between the stent-graft and a wall of the abnormality (see Fig. 7; [0086]). Inoue further teaches the evaluation of implants with a frame and fabric for treatment of aneurysms [0112], wherein it is understood that aneurysms form sacs or cavities. Riley also teaches the positioning of sensors at an abnormality in vasculature. Therefore, one of one of ordinary skill in the art would have found it further obvious to place the catheter of modified Inoue such that the distal sensor located between the abnormality wall and stent graft within the abnormality cavity.
Regarding claim 5, it would have been further obvious to move the catheter relative to the guidewire according to Steenwyk’s teaching [0067] to achieve desired positioning of the sensors.
Regarding claim 6, Steenwyk teaches that the first deploying step (deploying the guidewire) occurs before the second deploying step (deploying the stent graft/ prosthetic valve) [0057]. Riley additionally teaches deploying the device (100) having the sensors before delivering the implant (110) (Fig. 28-29; col 14, lines 15-56). Therefore, it would have been obvious to deploy the ancillary device before deployment of the stent graft in order, as the modification obtains predictable results of measuring pressure gradient data in vasculature.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Inoue.
Inouye discloses a step of introducing a pressure reducing agent (fluid 36) into the abnormality cavity (50) through a distal end of the ancillary device (34). Inouye describes that there are ideal parameters of fluid flow and pressure if a proper seal is achieved between the implant and the tissue wall [0075-0080]. Although not explicitly stated, it would have been obvious to one of ordinary skill in the art before the time of invention to cease the flow of fluid from the pump if a desired pressure gradient is detected.
Claim(s) 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2024/0033080 (Steenwyk et al.) in view of Inoue.
Regarding claim 16: Steenwyk discloses an endovascular pressure sensing device for outputting pressure data indicative of a pressure gradient between proximal and distal locations within a vasculature of a patient, the endovascular pressure sensing device comprising a first ancillary device component (guidewire 208) carrying a distal sensor (216) and a second ancillary device component (delivery device 202) having a proximal sensor (218). The first and second ancillary device components are moveable relative to one another, so that the proximal sensor is moveable relative to the distal sensor [0074-0075].
The ancillary device (combination of 208 and 202) is deployable within the vasculature relative to a stent graft (210) within the vasculature (Fig. 9; [0074-0075]). The proximal sensor (218) is configured to output proximal pressure data indicative of pressure at the proximal location and the distal sensor (216) is configured to output distal pressure data indicative of pressure at the distal location [0050; 0068; 0074-0075; 0081].
Steenwyk fails to disclose two radially and longitudinally offset proximal sensors on the first ancillary component (202). Inoue discloses an analogous endovascular pressure sensing assembly and teaches that it is obvious to include more than two sensors on an ancillary device [0072]. Steenwyk also teaches that the number and arrangement of sensors can be changed to simultaneously measure pressure data in more than two locations [0088]. An embodiment in Fig. 13 has a plurality of sensors (700) on a single component that are arranged radially offset from one another. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrangement two sensors on the second ancillary device (202) offset from one another, in order to provide measurement data in an additional location. It has been held that a mere duplication of the elements of a device involves only routine skill in the art. St. Regis Paper Co. v Bemis Co., 193 USPQ 8.
Regarding claim 17, a distal portion of the second ancillary device (202) has a cylindrical profile.
Regarding claim 18, with regards to the embodiment of Figure 9, Steenwyk discloses the proximal and distal arrangement of the sensors can be switched relative to the stent graft (prosthetic heart valve) (see [0065; 0076]). Therefore, the guidewire (208) can be second ancillary device having the first and second proximal sensors and the catheter (202) can be the first ancillary device having the distal sensor.
Regarding claim 19, Steenwyk discloses an electrical connector configured to output the proximal and/or distal pressure data and the ancillary guidewire includes one or more electrical contacts configured to electrically connect the distal sensor to the electrical connector [0058].
Regarding claim 20, one ancillary device is the guidewire (208) capable of being inserted in arteries or veins (see Fig. 9), and the other ancillary device is the delivery catheter (202).
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774