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 preliminary amendment to the claims filed 17 July 2023 has been entered. Claim(s) 1-5 and 7-11 is/are currently amended. Claim(s) 1-11 is/are pending.
Claim Objections
Claim(s) 6 is/are objected to because of the following informalities: references to the drawing reference number/letters (i.e., "(C)") should be deleted for consistency with Applicant's amendments to the claims (e.g., to claim 1, removing all drawing reference numbers).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, 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(s) 1-2, 5-7 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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.
Regarding claim 1, claim 6 and claims dependent thereon, there is insufficient antecedent basis for the limitations "the human body," "the insertion sheath," "the other electrode," and "the receiver" in claim 1. Similarly, there is insufficient antecedent basis for the limitations "the human body," "the coronary reserve," "the other electrode," and "the receiver" in claim 6.
Regarding claim 2, claim 7 and claims dependent thereon, there is insufficient antecedent basis for the limitations "the anode" and "the cathode" in each of claims 2 and 7.
Regarding claim 5 and claims dependent thereon, the limitation "so as to be able to engage on peripheral arterial or venous catheter sheaths of different diameters" is indefinite. It is unclear how, if at all, the "peripheral arterial or venous catheter sheaths" of claim 5 relates to the accessory catheter that the sleeve is adapted to be engaged around of claim 1. Are these the same catheter, is the sleeve adapted to/able to engage both accessory catheters and peripheral arterial or venous catheter sheaths?
The limitation "typically external diameters of between 1.6 and 20 mm" is further unclear. It is unclear if the sleeve as claimed is required to be able to engage any external diameter between 1.6 and 20 mm, or the limitation is merely describing "typical" external diameters of peripheral arterial or venous catheter sheaths. If the latter, it is further unclear if the limitation contains a typographical error, and should read "between 1.6 and 2.0 mm." Specifically, Applicant discloses, "Such an arterial catheter 1 can be of small diameter, typically 2 mm or less, and of short length" (pg. 11, lines 17-18). Additionally, the examiner is unable to locate any evidence that peripheral arterial or venous catheter sheaths are "typically" in the larger end of the claimed range, e.g., up to 20 mm.
For the purpose of this Office action, claim 5 will be discussed with the understanding the sleeve is required to be elastic and able to engage on accessory catheters of different diameters.
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 (Faurie '011) in view of WO 2020/236492 A1 (Lalancette).
Regarding claims 1 and 10-11, Faurie '011 discloses/suggests an 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.);
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.); and
a coronary angioplasty assembly for placement of a stent, the guidewire being 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; ¶ [0003] assembly can be used as a coronary angioplasty assembly for fitting of a prosthesis, i.e., stent).
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, 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 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 the anode, while the electrode of the cardiac stimulator connected to the metal part of the guidewire is the 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 peripheral arterial or venous catheter sheaths of different diameters, typically external diameters of between 1.6 and 20 mm (e.g., ¶ [0062]).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071092 A1 (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 the anode, while the electrode of the cardiac stimulator connected to the metal part of the guidewire is the 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]).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim(s) 6-9 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-3 and 7 of USPN 11,045,318 (cited by Applicant, Faurie '318) in view of Lalancette.
Although the claims at issue are not identical, they are not patentably distinct from each other because 1-3 and 7 of Faurie '318 recites each limitation of claims 6-9 of the present application with the exception of the guide wire comprising, in its distal portion, a pressure sensor for measuring the coronary reserve, and the metal part also serving as a connection to a receiver of the pressure measured by the sensor. As discussed with respect to the prior art rejections above, Lalancette discloses these features, such that it would have been obvious to modify claims 1-3 and 7 of Faurie '318 in order to facilitate providing information about blood flow at a treatment site before, during and/or immediately after deployment of a structural device, and eliminating the need for a separate stimulation device and/or for exchange of such devices to sequentially provide these capabilities.
Claim(s) 1-10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5 and 7-10 of USPN 11,559,331 (cited by Applicant, Faurie '331) in view of Lalancette.
Although the claims at issue are not identical, they are not patentably distinct from each other because 1-5 and 7-10 of Faurie '331 recites each limitation of claims 1-10 of the present application with the exception of the guide wire comprising, in its distal portion, a pressure sensor for measuring the coronary reserve, and the metal part also serving as a connection to a receiver of the pressure measured by the sensor, wherein the pressure sensor is a piezoelectric or fiber-optic sensor. As discussed with respect to the prior art rejections above, Lalancette discloses these features, such that it would have been obvious to modify claims 1-5 and 7-10 of Faurie '331 in order to facilitate providing information about blood flow at a treatment site before, during and/or immediately after deployment of a structural device, and eliminating the need for a separate stimulation device and/or for exchange of such devices to sequentially provide these capabilities.
Claim(s) 11 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 6 of Faurie '331 in view of Lalancette as applied above, and further in view of Faurie '011.
Claim 6 of Faurie '331 as modified by Lalancette above recites each limitation of claim 11 of the present application and further recites the assembly comprises an assembly for placement of an implant, the guidewire being adapted for advancing the implant (the guidewire being adapted for the advance of an artificial valve intended to replace the cardiac valve). Accordingly, claim 6 of Faurie '331 does not recite the assembly for placement of an implant advanced by the guide wire comprises a coronary angioplasty assembly for placement of a stent. However, as discussed in the prior art rejections above, Faurie '011 discloses/suggests an assembly usable for replacement of an aortic valve may alternatively be used as a coronary angioplasty assembly that may require the fitting of a prosthesis or stent (¶ [0003]). Accordingly, it would have been obvious to modify claim 6 of Faurie '331 with the assembly comprising a coronary angioplasty assembly for placement of a stent, the guidewire being adapted for advancing the stent as taught/suggested by Faurie '011 in order to adapt the assembly for use as a coronary angioplasty assembly (Faurie '011, ¶ [0003]).
Conclusion
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.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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