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 .
Priority
Claims 1-20 are deemed to have an effective filing date of March 30, 2023.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” has been used to designate both a percutaneous circulatory support device having the structure illustrated in Fig. 2 and a percutaneous circulatory support device having the structure illustrated in Fig. 3.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 300.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 8-13 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.
Claim 8, line 9, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claim 12, line 3, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 9-11 and 14 are rejected because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 6, 8-9, 11-12, 14, 16-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 9,789, 238 to Aboul-Hosn et al. (hereinafter referred to as “Aboul-Hosn”).
Regarding claim 1, Aboul-Hosn discloses a percutaneous circulatory support device (e.g., title and column 1, lines 53-56: intravascular blood pumps are percutaneously introduced into the vascular system of a patient to provide left and/or right heart support), comprising: an impeller housing comprising a proximal end portion (e.g., column 10, lines 1-7: blood pump 12 includes pump body 34, a rotor shroud having flow ports 38, and an impeller rotatably disposed within the rotor shroud; Figs. 1-2 and 10), and the impeller housing being configured to receive a guidewire during delivery of the percutaneous circulatory support device to a patient (e.g., column 8, line 62 – column 9, line 15: The “over-the-wire” guide mechanism 16 comprises a suitable guide element (e.g., guide wire 22) that passes through the drive cable 18, blood pump 12, and cannula 14; Figs. 1-2 and 10) ; an impeller being rotatable in the impeller housing to cause blood to flow through the percutaneous circulatory support device (e.g., column 10, lines 1-4: Cannula 14 [of the percutaneous circulatory support] allows for ingress or egress of blood into or from the cannula depending upon the operation of the pump 12); and a catheter coupled to the proximal end portion of the impeller housing (e.g., column 15, lines 5-28: a guide catheter 132 is provided to position the pump 12 and the cannula 14 at a desired position – see Fig. 10 where the catheter 132 is proximal to the impeller housing 12), the catheter comprising a lumen being configured to receive the guidewire during delivery of the percutaneous circulatory support device to the patient (e.g., column 8, line 62-column 9, line 40: a guide catheter may be used to control features of the guide wire 22, which extends through a lumen of the drive cable 18; column 10, lines 58-60: Figs. 3-4 further detail the construction of blood pump 12, drive cable assembly 18, cannula 14, and “over-the-wire” guide mechanism 16, where the drive cable assembly has a lumen for receiving the guide wire, and is within guide catheter 132 during delivery – column 19, line 58-column 20, line 4).
Referring to claim 8, Abou-Hosn discloses a percutaneous circulatory support device (e.g., title and column 1, lines 53-56: intravascular blood pumps are percutaneously introduced into the vascular system of a patient to provide left and/or right heart support), comprising: an inlet (see annotated Fig. 1); an outlet (see
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annotated Fig. 1); an impeller being rotatable to cause blood to flow into the inlet, through the percutaneous circulatory support device and out of the outlet (e.g., column 10, lines 1-7: blood pump 12 includes pump body 34, a rotor shroud having flow ports 38, and an impeller rotatably disposed within the rotor shroud and a cannula 14 [of the percutaneous circulatory support] allows for ingress or egress of blood into or from the cannula depending upon the operation of the pump 12); and a catheter disposed proximally relative to the impeller (e.g., column 15, lines 5-28: a guide catheter 132 is provided to position the pump 12 and the cannula 14 at a desired position – see Fig. 10 where the catheter 132 is proximal to the impeller housing 12), the catheter comprising a lumen; wherein the percutaneous circulatory support device is configured to receive a guidewire during delivery to a patient such that the guidewire is capable of extending out of the outlet and through the lumen of the catheter (e.g., column 8, line 62-column 9, line 40: a guide catheter may be used to control features of the guide wire 22, which extends through a lumen of the drive cable 18; column 10, lines 58-60: Figs. 3-4 further detail the construction of blood pump 12, drive cable assembly 18, cannula 14, and “over-the-wire” guide mechanism 16, where the drive cable assembly has a lumen for receiving the guide wire, and is within guide catheter 132 during delivery – column 19, line 58-column 20, line 4).
Regarding claim 14, Aboul-Hosn discloses a method of delivering a percutaneous circulatory support device to a patient (e.g., title and column 1, lines 53-56: intravascular blood pumps are percutaneously introduced into the vascular system of a patient to provide left and/or right heart support), the method comprising: positioning a guidewire in the patient (e.g., column 9, lines 16-25: guide wire is introduced into the vascular system of a patient … any may be advanced within the patient to a desired location); inserting the guidewire through a housing of the percutaneous circulatory support device and into a lumen of a catheter of the percutaneous circulatory support device (e.g., column 9, lines 28-32: guide wire 22 is inserted into blood pump (impeller housing) 12; and column 10, lines 58-60: Figs. 3-4 further detail the construction of blood pump 12, drive cable assembly 18, cannula 14, and “over-the-wire” guide mechanism 16, where the drive cable assembly has a lumen for receiving the guide wire, and is within guide catheter 132 during delivery – column 19, line 58-column 20, line 4); and advancing the percutaneous circulatory support device along the guidewire (e.g., column 10, lines 30-40).
With respect to claims 2 and 12, Aboul-Hosn discloses the percutaneous circulatory support device of claims 1 and 8, wherein the impeller housing comprises an outlet (see annotated Fig. 1), the impeller being rotatable in the impeller housing to cause blood to flow through the percutaneous circulatory support device and out of the outlet (e.g., column 10, lines 1-7: blood pump 12 includes pump body 34, a rotor shroud having flow ports 38, and an impeller rotatably disposed within the rotor shroud and a cannula 14 [of the percutaneous circulatory support] allows for ingress or egress of blood into or from the cannula depending upon the operation of the pump 12), and the outlet capable of permitting the guidewire to extend therethrough during delivery of the percutaneous circulatory support device to the patient (the outlets shown in annotated Fig. 1 are large enough to receive the guide wire).
As to claims 3, 9, and 17, Aboul-Hosn discloses the percutaneous circulatory support device of claims 1 and 8, and the method of claim 14, wherein the lumen is an auxiliary lumen (e.g., column 11, line 64 – column 12, line 2 and column 19, line 58-column 20, line 4: when the drive cable 18 is within catheter 132 for delivery of the percutaneous circulatory device, the lumen of drive cable 18 is the auxiliary lumen), the catheter further comprises a primary lumen, and further comprising a cable disposed in the primary lumen, the cable being operatively coupled to the impeller (e.g., column 19, line 58-column 20, line 24: see Fig. 15: drive cable 18 is within a lumen of catheter 132).
With respect to claim 6, Aboul-Hosn discloses the percutaneous circulatory support device of claim 1, wherein the impeller housing further comprises a distal end portion opposite the proximal end portion, and further comprising a cannula coupled to the distal end portion of the impeller housing, the cannula being configured to receive the guidewire (e.g., column 9, lines 2-6: guide element/wire is dimensioned to pass through a central lumen passing through cannula 14; column 10, lines 1-7: blood pump 12 includes pump body 34, a rotor shroud having flow ports 38, and an impeller rotatably disposed within the rotor shroud and a cannula 14 [of the percutaneous circulatory support] allows for ingress or egress of blood into or from the cannula depending upon the operation of the pump 12).
As to claims 11 and 19, Aboul-Hosn discloses the percutaneous circulatory support device of claim 9 and the method of claim 17, wherein the catheter comprises an outer circumferential surface, and the primary lumen and the auxiliary lumen are disposed radially inwardly from the outer circumferential surface (see Fig. 15 where the catheter 132 has an outer circumferential surface, and two lumens are disposed radially inwardly from the outer circumferential surface).
With respect to claim 16, Aboul-Hosn discloses the method of claim 14, wherein inserting the guidewire comprises inserting the guidewire through a cannula of the percutaneous circulatory support device (e.g., column 9, lines 2-6: guide element/wire is dimensioned to pass through a central lumen passing through cannula 14).
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.
Claims 4-5, 10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Aboul Hosn in view of US Patent Application Publication No. 2023/0256231 to Horne (EFD at least 02/10/2023).
With respect to claims 4, 10 and 18, Aboul-Hosn discloses the percutaneous circulatory support device of claims 3 and 9, and the method of claim 14, but does not expressly disclose that the catheter comprises a first wall and a second wall coupled to the first wall, the first wall defining the primary lumen and the second wall defining the auxiliary lumen. However, Horne, in a related art: ventricular assist devices, teaches that a drive shaft housing/catheter 511 may include lumens 3722 within the wall of the drive shaft housing/catheter which may accommodate the passage of wires (e.g., paragraph [0209] of Horne and Fig. 37B). Thus, one of ordinary skill in the art would have recognized the benefits of having more than one lumen within a catheter to define first and second walls within the wall of the catheter; or, a primary lumen (central main lumen) defined by a first wall and an auxiliary lumen with a wall defining the auxiliary lumen and coupled to the first wall in view of the teachings of Horne. Consequently, one of ordinary skill in the art would have modified the guide catheter to have a lumen within the wall of the guide catheter to accommodate a guide wire in view of the teachings of Horne that such structure was a well-known engineering expedient in the percutaneous assist device art, and because the combination would have yielded a predictable result.
As to claim 5, Aboul-Hosn discloses the percutaneous circulatory support device of claim 4, wherein the catheter comprises an outer circumferential surface, and the primary lumen and the auxiliary lumen are disposed radially inwardly from the outer circumferential surface (e.g., paragraph [0209] and Fig. 37B of Horne). Thus, one of ordinary skill in the art would have recognized the benefits of a catheter having an outer circumferential surface and the primary lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface in view of the teachings of Horne. Consequently, one of ordinary skill in the art would have modified the guide catheter of Horne to have a lumen within the wall of the guide catheter to have an auxiliary lumen that accommodates a guide wire in view of the teachings of Horne that such structure was a well-known engineering expedient in the percutaneous assist device art, and because the combination would have yielded a predictable result.
Claims 7, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosn.
Aboul-Hosn discloses the percutaneous circulatory support device of claims 1 and 8, and the method of claim 14, wherein the lumen has a length (e.g., column 9, lines 55-67), but does not expressly disclose that the length is in a range of 1 in. to 12 in. However, Aboul-Hosn does teach that the length of the drive cable assembly (and all components thereof) may be provided in any suitable length sufficient for intravascular applications. With respect to length of the catheter being from 1 in. to 12 in., it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Aboul-Hosn so that the length of the catheter is within the recited range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and Applicant does not appear to provide criticality for length of the catheter being within the recited range.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-7, 8-9 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 and 8 of copending Application No. 18/617,010 (US 2024/0325725) in view of Aboul-Hosn.
Claim 1 of the instant application conflicts is coextensive with claims 1 and 8 of the ‘010 application, except for a catheter coupled to a proximal end of the impeller housing where the catheter has a lumen for receiving the guidewire. However, Aboul-Hosn teaches that such a catheter was a well-known engineering component in the percutaneously circulatory support art as discussed above w/r/t the rejection of claim 1. Consequently, it would have been obvious to one of ordinary skill in the art to modify the percutaneous circulatory support system to have such a catheter.
Claim 8 of the instant application is conflicting or coextensive with claims 3-4 of the ‘010 application as modified by Aboul-Hosn as discussed above w/r/t the rejection of claim 8.
Claim 2 of the instant application conflicts or is coextensive with claims 3-4 of the ‘010 application as modified by Aboul-Hosn as discussed above w/r/t the rejection of claims 2 and 12.
Claims 3 and 9 of the instant application conflicts or is coextensive with claims 1 or 8 as modified by Aboul-Hosn as discussed above w/r/t the rejection of claims 3 and 9.
Claims 6 and 12 of the instant application is conflicting or coextensive with claim 2 of the ‘010 application as modified by Aboul-Hosn.
Claims 7 and 13 of the instant application is conflicting or coextensive with claims 1 and 8 as modified by Aboul-Hosn, except for the recited length of the catheter. However, in the absence of criticality, it would have been obvious to one of ordinary skill in the art to modify the length of the catheter to be within the range of 1 in. to 12 in. (see In re Aller).
This is a provisional nonstatutory double patenting rejection.
Claims 4-5 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4 of copending Application No. 18/617,010 in view of Aboul-Hosn and Horne.
Claims 4-5 and 10-11 add a limitation to the catheter structure so that is has two lumens: a primary lumen and an auxiliary lumen. However, Horne, in a related art: ventricular assist devices, teaches that a drive shaft housing/catheter 511 may include lumens 3722 within the wall of the drive shaft housing/catheter which may accommodate the passage of wires (e.g., paragraph [0209] of Horne and Fig. 37B). Thus, one of ordinary skill in the art would have recognized the benefits of having more than one lumen within a catheter to define first and second walls within the wall of the catheter; or, a primary lumen (central main lumen) defined by a first wall and an auxiliary lumen with a wall defining the auxiliary lumen and coupled to the first wall in view of the teachings of Horne. Consequently, one of ordinary skill in the art would have modified the catheter of claims 3-4 of the ‘010 application to have a lumen within the wall of the guide catheter to accommodate a guide wire in view of the teachings of Horne that such structure was a well-known engineering expedient in the percutaneous assist device art, and because the combination would have yielded a predictable result.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 6-7, 8-9 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 and 8, 10-11 of copending Application No. 18/385,700 (US 2024/0165392) in view of Aboul-Hosn.
Claim 1 of the instant application conflicts is coextensive with claims 1 and 8 of the ‘700 application, except for a catheter coupled to a proximal end of the impeller housing where the catheter has a lumen for receiving the guidewire. However, Aboul-Hosn teaches that such a catheter was a well-known engineering component in the percutaneously circulatory support art as discussed above w/r/t the rejection of claim 1. Consequently, it would have been obvious to one of ordinary skill in the art to modify the percutaneous circulatory support system to have such a catheter.
Claim 8 of the instant application is conflicting or coextensive with claims 10-11 of the ‘700 application as modified by Aboul-Hosn as discussed above w/r/t the rejection of claim 8.
Claim 2 of the instant application conflicts or is coextensive with claims 3-4 of the ‘700 application as modified by Aboul-Hosn as discussed above w/r/t the rejection of claims 2 and 12.
Claims 3 and 9 of the instant application conflicts or is coextensive with claims 1 or 8 of the ‘700 application as modified by Aboul-Hosn as discussed above w/r/t the rejection of claims 3 and 9.
Claims 6 and 12 of the instant application is conflicting or coextensive with claim 2 and 8 of the ‘700 application as modified by Aboul-Hosn.
Claims 7 and 13 of the instant application is conflicting or coextensive with claims 1 and 8 of the ‘700 application as modified by Aboul-Hosn, except for the recited length of the catheter. However, in the absence of criticality, it would have been obvious to one of ordinary skill in the art to modify the length of the catheter to be within the range of 1 in. to 12 in. (see In re Aller).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 6,248,091 to Voelker is directed to a balloon catheter that has a guidewire that extends through the outlet of the impeller housing (e.g., see column 3, lines 34-55 and Fig. 2).
US Patent Application Publication No. 2024/0335651 to Mitze et al. is directed to a mechanical circulatory support device where the guidewire goes outside the catheter to avoid the impeller (EFD: at least 08/02/2022 and see Figs. 7-8 and corresponding passages).
US Patent Application Publication No. 2025/0082922 to Fabiunke et al. (EFD: at least 07/20/2022) which has a percutaneous circulatory support device that anticipates claims 1-3, 6, 8-9, 12, 14, 16-17, and 19-20.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 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, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792