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 .
Election/Restrictions
1. Applicant’s election without traverse of Group I- claims 1-18 in the reply filed on 06/04/2026 is acknowledged.
Information Disclosure Statement
2. The information disclosure statements filed 4/17/2024, 11/6/2024 and 6/4/2026 contain more than 1,400 references. It is impossible for the Examiner to give more than a cursory review of the enormous amount of references with respect to the patentability of the claims. The references have been entered into the application but a determination of patentability of the claims with regard to this enormous amount of references is impossible to make within the time allotted for examination of this application. Applicant is requested to submit a document indicating which references are highly relevant to the current claims in response to this office action.
Claim Objections
3. Claims 1, 4, 8, and 10 are objected to because of the following informalities:
Claims 1, 4, 8, and 10 use the phrase “the shaft” (Claim 1 line 9; Claim 4 line 3; Claim 8 lines 7 and 8; and Claim 10 line 4). While it is clear that this references the “hollow shaft” of claim 1 and elsewhere, Applicant should amend this phrase to “the hollow shaft” in each instance to directly show its antecedent basis.
Appropriate correction is required.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
4. 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.
5. Claims 1-7, 9, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US 2020/0237986; hereafter Tuval) in view of Fernano et al. (US 2017/0258981; hereafter Fernano).
Regarding claim 1, Tuval teaches a method shown in Figures 10B-10F wherein a drive cable (drive cable- 130), which includes a plurality of coiled wires is inserted into a hollow-shaft end of a hollow shaft (axial shaft; noted as a tube in [0250]) into opposing ends of a coupling tube (butt-welding overtube- 160), which is shaped to define multiple coupling-tube pores (window- 162 and helical grooves- 164; [0315]-[0316]). While the drive-cable end and hollow-shaft end are inside the coupling tube, a plurality of welding rings are applied over the coupling tube so that after welding the drive cable and shaft are bonded ([0317]-[0318]). This includes a welding ring over the window, which would be bonding the coiled wires at the drive-cable end via the coupling-tube pores.
Tuval does not teach that the hollow shaft includes shaft pores or that molten material is applied for bonding. Fernano teaches that when bonding cylindrical members it is advantageous that the shafts have holes and that molten material is flowed, so that all members are mechanically conjoined ([0190]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the proposed invention to include shaft pores in the hollow shaft of Tuval and to flow a molten material between the coupling tube, drive-cable, and hollow shaft of Tuval for the advantage of all materials being mechanically joined.
Regarding claim 2, Tuval teaches that the coiled wires on their own (which is prior to insertion into the coupling tube) are “tightly coiled” ([0311]), which under the broadest reasonable interpretation can be interpreted as being merged. This would include at the drive cable end of the drive cable as the whole drive cable is tightly coiled.
Regarding claim 3, in applying Franano as in claim 1, Franano teaches that the molten material is applied by heat lamination ([0190]). While Tuval does not teach using pressure during bonding, Tuval does teach the use of pressure in similar process for the advantage of cylindrical shaping ([0145]) It would have been obvious to one of ordinary skill in the art before the effective filing date of the proposed invention to include pressure while bonding for the advantage of cylindrical shaping.
Regarding claim 4, Tuval teaches that the drive cable is hollow as it is part of a continuous lumen ([0314]; also shown in Figure 10C). While Tuval does not teach using a mandrel for the drive cable and hollow shaft, Tuval does teach the use of mandrels in similar process for the advantage of defining the lumen ([0254]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the proposed invention to put the drive cable and shaft over a mandrel for the advantage of defining the lumen during bonding.
Regarding claim 5, Tuval teaches that the drive-cable end is the distal end of the drive cable and the hollow-shaft end is the proximal end of the axial shaft ([0311]). The hollow shaft is connected to a rotating element (impeller; [0010]) and due to its connection to the drive-cable it couples the drive-cable to the rotating element and is configured to rotate the drive cable.
Regarding claim 6, the welding rings of Tuval under the broadest reasonable interpretation can be interpreted as sleeves, which as noted in the rejection of claim 1 is over the coupling tube. While Tuval does not teach using an outer sleeve that is around the sleeve or shrinking the outer sleeve during bonding, Tuval does teach the use of a silicone tube that applies pressure to a tubular member during thermoforming for the advantage of structural conformity ([0017]). This pressure is applied by the silicone tube shrinking, and since it’s the outer sleeve, heating would have to apply to the outer sleeve prior to heating the inner sleeve. It would have been obvious to one of ordinary skill in the art before the effective filing date of the proposed invention to put the drive cable and shaft over a mandrel for the advantage of structural conformity during bonding.
Regarding claim 7, in applying Franano as in claim 1, Franano does not teach that the molten material is polyether ether ketone. However, Tuval teaches that polyether ether ketone is an advantageous material due to its high resistance to fatigue ([0311]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the proposed invention to have the molten material include polyether ether ketone for the advantage of high resistance to fatigue.
Regarding claim 9, in applying Franano as in claim 1, Franano teaches that the cylindrical members are heat laminated ([0190]) and therefore in application to Tuval, the coupling tube would be compliant so as to conform both to the first outer diameter and to the second outer diameter. In regards to the diameter of the drive-cable and hollow-shaft, Tuval teaches that each can have a diameter in a range between 0.6mm- 1.2mm ([0314]). Since these are separate values, it is envisioned that in some circumstance a first outer diameter of the drive-cable end is greater than a second outer diameter of the hollow-shaft end as part of being in within this range.
Regarding claim 17, Tuval teaches that the drive-cable end is the distal end of the drive cable and the hollow-shaft end is the proximal end of the axial shaft ([0311]), and that the hollow shaft (which is noted as an axial shaft in the rejection of claim 1) is coupled to and configured to rotate, an impeller for an intracorporeal blood pump, the hollow-shaft end being a proximal end of the axial shaft ([0010]).
Regarding claim 18, Tuval teaches that the drive cable is inserted (or disposed) into a delivery tube (delivery catheter- 143) that is coupled to a bearing housing (first outer tube- 140) that is configured to radially stabilize the axial shaft while the axial shaft rotates the impeller ([0015]; [0311]-[0312]). As the distal end of the drive cable is disposed to the proximal end of the axial shaft ([0311]), the distal end of the drive cable is consequentially disposed within the bearing housing proximally to the radial bearing.
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.
6. Claims 1-2, 5, and 9-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/637,655 (hereafter ‘655). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, ‘655 teaches a method, comprising: inserting a drive-cable end of a drive cable, which includes a plurality of coiled wires, and a hollow-shaft end of a hollow shaft into opposing ends of a coupling tube (Claim 1 lines 1-4), and then while the drive-cable end and hollow-shaft end are inside the coupling tube, flowing a molten material between the coiled wires at the drive-cable end via the coupling-tube pores, and into the hollow-shaft end via the coupling-tube pores and shaft pores, such that, upon solidifying, the material bonds the drive cable to the shaft (Claim 2). ‘655 teaches that the coupling tube has multiple coupling-tube pores (noted in Claim 2 as “multiple pores” and further supported by Claim 3).
Regarding claim 2, Claim 4 of ‘655 teaches these limitations near verbatim.
Regarding claim 5, Claim 5 of ‘655 teaches these limitations near verbatim.
Regarding claim 9, Claim 21 of ‘655 teaches these limitations in a related apparatus claim, which could be applied to the claimed method.
Regarding claim 10, these limitations are taught in Claim 1 lines 4-7 and Claim 2 lines 1-2 of ‘655.
Regarding claim 11, these limitations are taught near verbatim in Claim 7 of ‘655.
Regarding claim 12, these limitations are taught near verbatim in Claim 8 of ‘655.
Regarding claim 13, these limitations are taught near verbatim in Claim 3 of ‘655.
Regarding claim 14, “pushing others of the tabs between the coiled wires” is taught in Claim 9 of ‘655, and in context of Claims 1 and 2 of ‘655 this occurs before the flowing of molten material.
Regarding claim 15, these limitations are taught near verbatim in Claim 10 of ‘655.
Regarding claim 16, these limitations are taught near verbatim in Claim 11 of ‘655.
Regarding claim 17, these limitations are taught near verbatim in Claim 12 of ‘655.
Regarding claim 18, these limitations are taught near verbatim in Claim 13 of ‘655.
7. Claims 1, 9, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/637,667 (hereafter ‘667). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, Claim 7 of ‘667 teaches nearly all of the structure of the established method step of immediate claim 1. The differences are that claim 1 of ‘667 doesn’t teach of “flowing a molten material” or the order of the steps. In regard to the “flowing of molten material’ limitation, Claim 1 of ‘667 teaches that the bonding material “solidified between the coiled wires”, which implies that at one point it was molten and flowed into the wires, and therefore this limitation is implicitly taught. In regard to step order, there are only two steps- insertion and flowing molten material. This provides two possible method step orders- insertion then flowing, or flowing then insertion; and with 2 possibilities the claimed order of insertion then flowing would be “Obvious to Try” to one of ordinary skill in the art, which establishes a prima facia case of obviousness as per MPEP 2143.01.E.
Regarding claim 9, these limitations are taught near verbatim to Claim 15 of ‘667
Regarding claim 17, Claim 1 in conjunction with Claim 7 of ‘667 teaches the hollow shaft is the axial shaft (Claim 7 line 3), which is coupled to, and configured to rotate, an impeller for an intracorporeal blood pump (Claim 1 lines 5-6). The drive-cable end is a distal end of the drive cable, and the hollow-shaft end is the proximal end of the axial shaft (Claim 7 line 6).
Allowable Subject Matter
8. Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
9. Claims 10-16 are not taught by the prior art, but must overcome the Double Patenting Rejection above prior to being allowable.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 8, Tuval teaches that the diameter of the drive-cable and hollow-shaft can each have a diameter in a range between 0.6mm- 1.2mm ([0314]). Since these are separate values, it is envisioned that in some circumstance a first outer diameter of the drive-cable end is greater than a second outer diameter of the hollow-shaft end as part of being in within this range.
Tuval does not teach or render obvious the inclusion of an adaptor tube and associated limitations.
Regarding claim 10, Tuval does teach the use of tabs in a structural frame ([0367]), however Tuval does not teach or render obvious the step of pushing at least some of the tabs into the shaft pores as the tabs suggested are preformed to fit into a premade structure.
10. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER S WRIGHT whose telephone number is (571) 272-8343. The examiner can normally be reached Monday- Friday 8:30am-5:00 pm EST.
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, Philip Tucker can be reached on 571-273-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S WRIGHT/Examiner, Art Unit 1745
/ALEX B EFTA/Primary Examiner, Art Unit 1745
/ALEX B EFTA/Primary Examiner, Art Unit 1745
