DETAILED ACTION
Applicant's election without traverse of Group 2 by Paul Stellman dated 9/15/25 is acknowledged.
Claims 2-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.
The examiner considers the amendment to claim 2 does not place Claims 2-7 under the elected Group because the sheath of Group 2 is not an obvious variant of the tether of Group 1.
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 8-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-7, 9-11, 13-15 of U.S. Patent No. 11351359. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a pump in a housing with struts contacting a blood vessel and having inflection points.
Claims 8-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 10-18 of U.S. Patent No. 11471665. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a pump in a housing with struts contacting a blood vessel and having inflection points.
Claims 8-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10-15, and 17-25 of U.S. Patent No. 11697017. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a pump in a housing with struts contacting a blood vessel and having inflection points.
Claims 8-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 10-16, 18-19, 21-23, 25-31, and 34-35 of U.S. Patent No. 12017060. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a pump in a housing with struts contacting a blood vessel and having inflection points.
Therefore, the claims of each of the preceding patents anticipate the claims of the current application.
Claims 8-9 and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4 and 6-17 of copending Application No. 18/165,212 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose vessel pumps with struts making intermittent contact with the vessel wall.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delgado (PG Pub. 2006/0036127).
Regarding Claim 8, Delgado discloses a blood flow assist system comprising:
a pump (see pump 110; Fig. 4; par. 33) comprising:
an impeller (see impeller 115) disposed in a pump housing (see housing 114); and a strut (see support member 121) comprising a first end disposed at or coupled with the pump housing (see Fig. 4), a second end (see end 122) opposite the first end, and an inflection zone (see hook 123) disposed between the first end and the second end, the second end elastically deflectable toward and away from a longitudinal axis of the pump (see Fig. 3 and 4), a free state of the strut spacing the second end thereof away from the longitudinal axis of the pump (see Fig. 4), the second end of the strut configured to engage a wall of the blood vessel (see wall surface 98’ of aorta 98; par. 34); and a sheath (see sheath 140) comprising an inner wall configured to be disposed over the pump and to deflect the strut between the first and the second end thereof (see Fig. 3); wherein the inflection zone is configured such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath (see inward curve of 121 in Fig. 3).
Regarding Claim 9, Delgado discloses wherein the second end of the strut comprises a hook (see hook 123). The examiner considers the inflection zone is the curve that produces the hook.
Regarding Claim 11, Delgado discloses further comprising a tether (see wire 117) coupled with a first end of the pump, the tether comprising an electrical conveyance comprising a conductor configured to convey current to and from a source (see battery; par. 41) connectable to a proximal end of the electrical conveyance (see par. 40).
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) 10, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delgado (PG Pub. 2006/0036127) in view of Najafi et al. (PG Pub. 2011/0303229).
Regarding Claim 10, Delgado does not disclose an S-shaped inflection zone. Najafi discloses a similar device having struts (see arms 26) implanted within a blood vessel (see par. 38) wherein the inflection zone comprises an S-connection between a first span of the strut and a second span of the strut, the first span and the second span being disposed along parallel trajectories (see modified Fig. 1 below and par. 21).
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It would have been obvious to one of ordinary skill in the art at the time of the invention to shape the arms in this way because Najafi teaches it allows for smooth corners and edges (see par. 30) for vessel contact.
Regarding Claim 12, Delgado does not disclose a convex contact pad at the end of the strut. Najafi discloses convex contact pads (see surfaces 36; par. 38) at a distal portion of the strut, the convex contact pads configured to contact a blood vessel wall to maintain spacing of the device housing from a blood vessel wall (see par. 24). It would have been obvious to one of ordinary skill in the art at the time of the invention to include convex contact pads at the ends of the struts because Najafi teaches they help to navigate blood vessel curvature without causing damage to the walls (see par. 38).
Regarding Claim 13, Najafi further discloses wherein a major lateral dimension of the at least a portion of the strut is less than a major lateral dimension of the device housing (see sheath 16 of catheter 14; see modified Fig. 5 below). It would have been obvious to one of ordinary skill in the art at the time of the invention o make the lateral dimension of the strut less than a lateral dimension of the housing for an easy, low-profile deployment (see par. 18-19 and 31). The examiner considers the lateral dimension of the strut in closed position is necessarily less than the lateral dimension of the housing because it must fit within the housing during deployment. Furthermore, the claim only requires “a portion” of the strut to be less than the lateral dimension of the housing in which case even the tiniest portion of the strut would read on the claim.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA PATEL whose telephone number is (571)272-5818. The examiner can normally be reached 9-5 M-F Eastern.
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/N.P/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792