DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 26 March 2026 has been entered. Claim(s) 1-2 and 5-7 is/are currently amended. Claim(s) 1-11 is/are pending.
Terminal Disclaimer(s)
The terminal disclaimer(s) filed on 26 March 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date(s) of USPN 11,045,318 and USPN 11,559,331 has/have been reviewed and is/are accepted. The terminal disclaimer(s) has/have been recorded.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) and/or double patenting rejections not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims, Applicant's submitted remarks and/or the above-noted terminal disclaimer(s).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-5 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0224011 A1 (previously cited, Faurie '011) in view of WO 2020/236492 A1 (previously cited, Lalancette).
Regarding claims 1 and 10-11, Faurie '011 discloses/suggests an assembly constituting at least a coronary angioplasty assembly for placement of a stent (¶ [0003] assembly can be used as a coronary angioplasty assembly for fitting of a prosthesis, i.e., stent), the assembly comprising:
an accessory catheter intended to be introduced into a peripheral artery or vein of a human body (introducer 1; ¶ [0051]; delivery catheter 1'; ¶ [0055]);
a sleeve adapted to be engaged around the accessory catheter, the sleeve being made of electrically conductive material over at least part of its outer periphery, such that, when the accessory catheter is introduced into the peripheral artery or vein of the human body, the conductive periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or vein, the sleeve being additionally connected to an electrical connection, itself connected to an electrode of a cardiac stimulator outside the body (sleeve 6; ¶¶ [0050]-[0052]; ¶¶ [0054]-[0056]; etc.); and
a guidewire intended to be introduced into an insertion sheath of the accessory catheter, the guidewire comprising, in its proximal portion, a metal part further serving as a connection to another electrode of the external cardiac stimulator (guide wire 20; ¶ [0053]; ¶ [0057]; Fig. 3; ¶ [0153]; etc.), wherein the guidewire is adapted for advancing the stent (¶ [0044] guide wire acts as a rail for advancing a stent-balloon assembly; ¶ [0148] assembly 21 including a radial expansion stent and a balloon; etc.).
Faurie '011 does not disclose the guide wire comprises, in its distal portion, a pressure sensor for measuring coronary reserve, or the metal part also serves as a connection to a receiver of the pressure measured by the sensor.
Lalancette discloses a guide wire intended to be introduced into an insertion sheath of an accessory catheter (e.g., pressure guidewire 308; ¶ [0008] pressure guidewire may be advanced through the access point to a location adjacent to a treatment site of the patient), the guidewire comprising, in its distal portion, a pressure sensor (¶ [0066] pressure sensor assembly 318 including pressure sensor 322 disposed within the lumen of the outer tube 310, 410, and/or a distal tip 432), and, in its proximal portion, a metal part serving as a connection to an electrode of an external cardiac stimulator and also as a connection to a receiver of the pressure measured by the sensor (¶ [0071] proximal end of the core wire 316, which may include a conductive material such as stainless steel, may be exposed from the proximal end of the outer tube 310 for connection to the monitor display 204 and/or connection to a current generator), wherein the pressure sensor is a piezoelectric or fiber-optic sensor (¶ [0072] pressure sensor 322 may be an optical or electrical sensor, membrane-based sensor, a MEMS sensor or other device that can generate a signal in response to pressure levels or fluctuations). Lalancette further discloses the guidewire is adapted for advancing a treatment device (e.g., ¶ [0008] treatment devices, such as a balloon or replacement heart valve, may be advanced over the pressure guidewire).
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 assembly of Faurie '011 with the guide wire comprising, in its distal portion, a pressure sensor for measuring coronary reserve, such as a piezoelectric or fiber-optic sensor, and the metal part of the guide wire also serving as a connection to a receiver of the pressure measured by the sensor as taught and/or suggested by Lalancette in order to facilitate providing information about blood flow (e.g., coronary reserve) through a coronary vessel before, during and/or immediately after deployment of a device (e.g., stent) (Lalancette, ¶ [0003]; Faurie '011, ¶ [0003]; etc.), and eliminating the need for a separate stimulation device and/or for exchange of such devices to sequentially provide these capabilities (Lalancette, ¶ [0010]).
Regarding claim 2, Faurie '011 as modified discloses/suggests the electrode of the cardiac stimulator connected to the electrically conductive sleeve engaged around the insertion sheath of the accessory catheter is an anode, while the electrode of the cardiac stimulator connected to the metal part of the guidewire is a cathode (e.g., ¶ [0058]).
Regarding claim 3, Faurie '011 as modified discloses/suggests the electrically conductive sleeve is formed as a single piece made of conductive material (e.g., ¶ [0060]).
Regarding claim 4, Faurie '011 as modified discloses/suggests the sleeve is formed by a sheath comprising on its outer periphery an electrically conductive coating (e.g., ¶ [0061]).
Regarding claim 5, Faurie '011 as modified discloses/suggests the sleeve is elastic so as to be able to engage on accessory catheters of different diameters (e.g., ¶ [0062]).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071092 A1 (previously cited, Faurie '092) in view of Lalancette.
Regarding claim 6, Faurie '092 discloses/suggests an assembly comprising:
an accessory catheter intended to be introduced into a peripheral artery or vein of the human body, the accessory catheter comprising at least one tubular insertion sheath and at least one electrically conductive element, of which a distal portion is exposed on at least one part of the outer periphery of the sheath in such a way as to be in contact with the subcutaneous tissue of the body or with the wall of the peripheral artery or vein, and of which a proximal portion, accessible from outside the body, comprises an electrical connection so as to serve as a connection to an electrode of a cardiac stimulator outside the body (introducer 1; ¶ [0049]; delivery catheter 1'; ¶ [0052]; etc.); and
a guidewire intended to be introduced into the insertion sheath of the accessory catheter, the guidewire comprising, in its proximal portion, a metal part serving as a connection to another electrode of the external cardiac stimulator (guide wire 20; ¶ [0050]; Fig. 3; ¶ [0145]; etc.).
Faurie '092 does not disclose the guide wire comprises, in its distal portion, a pressure sensor for measuring coronary reserve, or the metal part also serves as a connection to a receiver of the pressure measured by the sensor.
Lalancette discloses a guide wire intended to be introduced into an insertion sheath of an accessory catheter (e.g., pressure guidewire 308; ¶ [0008] pressure guidewire may be advanced through the access point to a location adjacent to a treatment site of the patient), the guidewire comprising, in its distal portion, a pressure sensor (¶ [0066] pressure sensor assembly 318 including pressure sensor 322 disposed within the lumen of the outer tube 310, 410, and/or a distal tip 432), and, in its proximal portion, a metal part serving as a connection to an electrode of an external cardiac stimulator and also as a connection to a receiver of the pressure measured by the sensor (¶ [0071] proximal end of the core wire 316, which may include a conductive material such as stainless steel, may be exposed from the proximal end of the outer tube 310 for connection to the monitor display 204 and/or connection to a current generator), wherein the pressure sensor is a piezoelectric or fiber-optic sensor (¶ [0072] pressure sensor 322 may be an optical or electrical sensor, membrane-based sensor, a MEMS sensor or other device that can generate a signal in response to pressure levels or fluctuations). Lalancette further discloses the guidewire is adapted for advancing a treatment device (e.g., ¶ [0008] treatment devices, such as a balloon or replacement heart valve, may be advanced over the pressure guidewire).
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 assembly of Faurie '092 with the guide wire comprising, in its distal portion, a pressure sensor for measuring coronary reserve, and the metal part of the guide wire also serving as a connection to a receiver of the pressure measured by the sensor as taught and/or suggested by Lalancette in order to facilitate providing information about blood flow (e.g., coronary reserve) through a coronary vessel before, during and/or immediately after deployment of a structural device (e.g., stent) (Lalancette, ¶ [0003]; Faurie '011, ¶ [0003]; etc.), and eliminating the need for a separate stimulation device and/or for exchange of such devices to sequentially provide these capabilities (Lalancette, ¶ [0010]).
Regarding claim 7, Faurie '092 as modified discloses/suggests the electrode of the cardiac stimulator connected to the accessory catheter is an anode, while the electrode of the cardiac stimulator connected to the metal part of the guidewire is a cathode (e.g., ¶ [0054]).
Regarding claim 8, Faurie '092 as modified discloses/suggests the electrically conductive element of the accessory catheter is a wire or a metal band housed at least partially within the thickness of the sheath, of which a distal portion is exposed at the outer periphery of the sheath (e.g., ¶ [0061]).
Regarding claim 9, Faurie '092 as modified discloses/suggests the cross section of the wire or of the metal band is between 0.25 and 5 mm2 (e.g., ¶ [0095]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejection of claim 1, Applicant contends, "Lalancette discloses that the pressure measurements obtained may be used to calculate a heart valve or blood flow index, such as a valve regurgitation index or a pressure gradient across a natural heart valve, a previous placed replacement heart valve or a replacement heart valve being currently implanted. (Lalancette, paragraphs [0048]-[0043]) Of note, this is fundamentally different from measuring coronary reserve (FFR), which involves measuring trans-stenotic pressure during maximum vasodilatation to quantify the impact of a coronary lesion" (Remarks, pg. 7).
The examiner first notes Applicant appears to be using "coronary reserve" interchangeably with fractional flow reserve ("FFR") (see, e.g., Remarks, pg. 7; specification as filed, pg. 14, lines 36-38; etc.), despite "coronary flow reserve" being a different, art-recognized parameter (i.e., ratio of maximum blood flow to resting blood flow). Accordingly, the scope of term "coronary reserve" as recited in the pending claims has been interpreted to encompass FFR and/or other coronary pressure measures consistent with the application as filed.
Secondly, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, it is well-known in the art that coronary pressure measurements, including FFR, are utilized for assessing a lesion to determine whether a prosthesis, i.e., stent, is needed. This is both explicitly acknowledged by Applicant (e.g., pg. 2, lines 8-32), and further suggested by the cited prior art. Specifically, Faurie '011, discloses and/or suggests using the assembly as a coronary angioplasty assembly "may or may not require the fitting of a prosthesis, which is commonly called 'stent'" (¶ [0003]), which one of ordinary skill in the art would readily appreciate typically involves some type of pressure and/or flow measurement to determine if said stent is needed. Further, Lalancette more expressly acknowledges pressure sensing around static lesions in coronary vessels is known (¶ [0005]). Additionally, the cited prior art discloses/suggests the same assembly may be used as a coronary angioplasty assembly or a structural heart (e.g., valve replacement) assembly (e.g., Faurie '011, ¶¶ [0001]-[0005]), thereby indicating the two types of assemblies are similar structurally, functionally, etc.; and further discloses having to insert additional, dedicated catheters during a procedure should be avoided (e.g., ¶ [0043]). Accordingly, while the assembly disclosed by Lalancette is expressly disclosed as being usable in structural heart procedures, there is no disclosure in any of the cited prior art that the structural/functional features of the assembly of Lalancette are not equally beneficial and/or predictable for use in a coronary angioplasty assembly (i.e., facilitate providing information about blood flow through a coronary vessel before, during and/or immediately after deployment of a device (e.g., stent), eliminating the need for a separate stimulation device and/or for exchange of such devices to sequentially provide these capabilities, etc.).
Applicant further contends, "Lalancette does not teach or suggest a guidewire wherein the metal part serves both as a connection to an electrode of an external cardiac stimulator AND as a connection to a receiver of the pressure measured by the sensor," asserting "The pressure wire leads are separate from the core wire used for pacing" (Remarks, pgs. 8).
The examiner respectfully disagrees. Lalancette discloses, "A proximal end of the core wire 316 may be exposed from the proximal end of the outer tube 310 for connection to the monitor display 204 and/or connection to a current generator" (¶ [0071]). Connection to a monitor display is described elsewhere as connecting the pressure sensor to a monitor assembly for assessment based on a pressure measurement(s) (¶¶ [0054]-[0057]). In at least one other passage, Lalancette more expressly discloses the same conductor may be utilized for both rapid pacing/delivering current and sensing pressure (¶ [0076], "In some configurations, current may alternatively or additionally flow through the one or more pressure wire leads 420."). Accordingly, Lalancette discloses the same "metal part," e.g., proximal end of the core wire or a wire lead, may be exposed to allow connection to both a cardiac stimulator and a receiver of pressure.
Applicant's remarks with respect to independent claim 6 and the pending dependent claims are substantially the same as presented with respect to claim 1, which are not persuasive for the reasons noted above. Accordingly, said rejections are similarly maintained.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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