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 .
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 9, 11 and 15 of U.S. Patent No. 12,161,854. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference (12,161,854)
Claim 1. A blood pump comprising:
Claim 8. A blood flow assist system comprising:
a primary impeller;
a first impeller configured to rotate, a lumen extending through a distal end of the first impeller
a flow tube routed through the primary impeller;
a secondary flow path along the lumen
rotatable piece comprising a secondary impeller, a conical opening, and the flow tube; and
Claim 9. a secondary impeller disposed on the impeller shaft
Claim 11. a flange at a proximal end of the impeller shaft, the secondary impeller disposed on a proximally facing surface of the flange.
a drive unit sealed by a drive unit cover, the drive unit cover comprising a conical member that matches the contour of and fits inside the conical opening.
Claim 8. a drive unit
Claim 15. a drive bearing, the drive bearing comprising a convex bearing surface
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 20, 21, 22 and 23 of U.S. Patent No. 11,452,859. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference (US 11,452,859)
Claim 1. A blood pump comprising:
Claim 10. A blood flow assist system comprising:
a primary impeller;
an impeller shaft and an impeller on the impeller shaft, the impeller shaft configured to rotate
a flow tube routed through the primary impeller;
Claim 20. a secondary flow path in a lumen of the impeller shaft
rotatable piece comprising a secondary impeller, a conical opening, and the flow tube; and
a secondary impeller disposed on the impeller shaft
a conical opening,
Claim 21. a flange, the secondary impeller disposed on a generally proximally-facing surface of the flange
and the flow tube; and
Claim 20. a secondary flow path in a lumen of the impeller shaft
a drive unit sealed by a drive unit cover, the drive unit cover comprising a conical member that matches the contour of and fits inside the conical opening.
Claim 22. a drive unit
Claim 23. a drive bearing, the drive bearing comprising a convex bearing surface
Claim 1 is provisionally rejected on the grounds of nonstatutory double patenting of claims 2, 4, 5, 8, 9 and 10 of copending Application No. 17/535,271. This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other.
Instant Application
Reference Application (17/535,271)
Claim 1. A blood pump comprising:
Claim 2. A blood flow assist system comprising:
a primary impeller;
an impeller coupled with a rotor assembly
a flow tube routed through the primary impeller;
Claim 4. wherein the rotor assembly comprises an impeller shaft
Claim 8. a second flow pathway through a lumen of the impeller shaft
rotatable piece comprising a secondary impeller,
Claim 5. a secondary impeller disposed on the impeller shaft
a conical opening,
Claim 9. an angled cavity
and the flow tube; and
Claim 8. a second flow pathway through a lumen of the impeller shaft
a drive unit sealed by a drive unit cover, the drive unit cover comprising a conical member that matches the contour of and fits inside the conical opening.
Claim 2. a drive unit comprising a drive magnet and a drive bearing,
Claim 10. the drive unit comprises a convex member sized to fit within the angled cavity
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 6 of U.S. Patent No. 11,779,751. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference (11,779,751)
Claim 1. A blood pump comprising:
Claim 1. A blood flow assist system comprising:
a primary impeller;
a first impeller interfacing with an outer surface of a rotatable member
a flow tube routed through the primary impeller;
a second flow pathway in a lumen of the rotatable member
rotatable piece comprising a secondary impeller,
a secondary impeller disposed on the rotatable member
a conical opening,
Claim 6. wherein the rotatable member further comprises an impeller shaft and a flange
and the flow tube; and
Claim 1. a second flow pathway in a lumen of the rotatable member
a drive unit sealed by a drive unit cover, the drive unit cover comprising a conical member that matches the contour of and fits inside the conical opening.
Claim 2. a drive unit, wherein the drive unit comprises a drive magnet, a drive bearing, the drive bearing comprising a convex bearing surface
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 7, 8, and 9 of U.S. Patent No. 11,517,736. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference (11,517,736)
Claim 1. A blood pump comprising:
Claim 1. A blood flow assist system comprising:
a primary impeller;
an impeller coupled with a rotor assembly
a flow tube routed through the primary impeller;
Claim 7. a second flow pathway through a lumen of the impeller shaft
rotatable piece comprising a secondary impeller,
Claim 3. wherein the rotor assembly comprises an impeller shaft
Claim 4. a secondary impeller disposed on the impeller shaft
a conical opening,
Claim 5. a flange
Claim 8. an angled cavity-facing surface of the flange
and the flow tube; and
Claim 7. a second flow pathway through a lumen of the impeller shaft
a drive unit sealed by a drive unit cover, the drive unit cover comprising a conical member that matches the contour of and fits inside the conical opening.
Claim 1. a drive unit, the drive unit comprising a drive magnet, a drive bearing
Claim 9. the drive unit comprises a convex member sized to fit within the angled cavity
Election/Restrictions
Newly submitted claims 14-17, 20 and 21 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Invention I (claims 2-13, 18 and 19) and Invention II (claims 14-17, 20 and 21) are related products. These inventions are distinct because they have a materially different design, mode of operation, function or effect. In the instant case, Invention I includes a “drive unit cover”, which is not a part of Invention II and Invention II includes a “a segmented cone bearing”, which is not a part of Invention I.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 14-17 and 19-21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments filed on 10/14/2025 have been fully considered but are not persuasive.
Applicant argues that one of ordinary skill in the art would have no reason to modify the pump of Siess with the fuel control system of Schaefer, Examiner respectfully disagrees. The flow path member of Siess and the flow tube of Shaefer are functionally equivalent given that they both enable the pump to use its own fluid for bearing lubrication. Examiner asserts that a skilled artisan looking to design a pump that uses its own fluid for lubrication would turn to either Siess or Schaefer for inspiration, because of their functional equivalence.
Regarding Applicants assertion that “the fuel control system of Schaefer would utilize a fuel that would be fatal to patient’s utilizing a blood pump”. Examiner notes that, in the rejection of claim 2, Shaefer is only being relied upon to teach an alternative location for a flow tube, not the use of jet fuel or other elements of the engine fuel control system. As described in the Non-Final Rejection (07/14/2025), the modification of Siess in view of Shafer would yield the blood pump of Siess having a flow tube routed through the primary impeller instead of the original location shown in Siess (Fig. 1).
Applicant argues that “Taskin teaches the use of a stationary shafter…” and that one of ordinary skill in the art “would have no reason to modify Siess to include a rotatable piece that includes a secondary impeller, conical opening and flow tube”, Examiner respectfully disagrees. The fact that Taskin teaches the use of a stationary shafter is irrelevant given that Taskin serves to provide additional evidence to support that it would have been obvious to one of ordinary skill in the art to modify Siess to include a flow tube routed through the primary impeller, as taught by Schaefer. Examiner also notes that Taskin is not relied upon to teach a rotatable piece, conical opening or a flow tube, as these limitations are already taught by the proposed combination of Siess in view of Shafer.
Claim Rejections - 35 USC § 112
9. 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 and 18 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.
In re claim 8, there is insufficient antecedent basis for the limitation “the two or more channels”. For examination purposes the limitation “the two or more channels” will be interpreted as “two or more channels”. Examiner notes that dependent claim 9 inherits the same deficiencies.
In re claim 18, there is insufficient antecedent basis for the limitation “the at least one channel”. For examination purposes, the limitation “the at least one channel” will be interpreted as “at least one channel”. Examiner notes that claim 19 inherits the same deficiencies.
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.
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.
Claims 2-5, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 2018/0050139), in view of Schaefer et al. (US 4,714,405), in view of Taskin et al. (US 2017/0296720).
In re claim 2, Siess discloses a blood pump (abstract; FIG. 1: 1) comprising:
a primary impeller (4)
a flow path member (30) coupled to the primary impeller ([0038]: “wash out channel 30 may extend at least partially into the main portion of the impeller”); and
a rotatable piece (33, 37) comprising:
a conical opening (base of 37 forms a conical opening),
and the flow path member; and
a drive unit (8) sealed by a drive unit cover (apparent, based on FIG. 1, that the drive unit is covered by a housing)
the drive unit cover comprising
a conical member (left side of drive unit) that matches the contour of and fits inside
the conical opening (FIG. 1).
Siess does not disclose
a flow tube routed through the primary impeller
the rotatable piece comprising:
a secondary impeller
Schaefer discloses a pump (abstract) with a flow tube (45; col. 4, lines 16-19) routed through an impeller (47). Schaefer further discloses using the fluid flowing through the flow tube to lubricate subsequent splines and bearings (col. 4, lines. 37-42). It should be noted that this function is similar to the function of the flow path member disclosed in Siess, which functions to wash or rinse the pivot bearing (Siess, [0038]).
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 pump of Siess to include a flow tube routed through the primary impeller, as taught by Schaefer. One would have been motivated to make this modification because it is a known equivalent pump configuration used to ensure components are properly lubricated.
Taskin provides additional evidence supporting that it would have been obvious to modify Siess to include a flow tube routed through the primary impeller, as taught by Schaefer. Specifically, Taskin discloses a blood pump (abstract), with a flow path (FIG. 4: 447) routed through a portion of an impeller (400).
Regarding the limitation
the rotatable piece comprising:
a secondary impeller
Taskin further discloses fluid driving elements (ridges or blades) attached to the bottom surface (438) of the impeller [0061].
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 rotatable piece taught by Siess, to include a secondary impeller, as taught by Taskin. One would have been motivated to make this modification because adding a secondary impeller would help drive blood over the bearing (Taskin, [0061]).
In re claim 3, Siess discloses
wherein the drive unit comprises a magnet sealed in the drive unit cover ([0037]: the motor is “magnetically coupled” to the impeller)
In re claim 4, Siess discloses
wherein the drive unit comprises a motor (8), the magnet rotatable by the motor ([0037]; apparent as the motor and impeller are magnetically coupled, and the motor is used to rotate the impeller).
In re claim 5, the proposed combination yields (mapping directed to Taskin)
wherein the secondary impeller comprises a plurality of vanes ([0061]: “ridges and blades” function as vanes as they guide blood through the impeller).
In re claim 18, the proposed combination yields (all mapping directed to Siess),
wherein, during operation of the blood pump, blood flows through the flow tube within the primary impeller (see above In re claim 1), and passes through the at least one channel (35 or 31; regarding the limitation “the at least one channel”, see above section Claim Rejections 112 (In re claim 18)).
In re claim 19, the proposed combination yields (all mapping directed to Taskin)
wherein during operation of the blood pump the blood is driven radially outward by vanes of the secondary impeller([0061]: “fluid driving elements” drive the blood “outwardly along the bottom surface”).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 2018/0050139), in view of Schaefer et al. (US 4,714,405), in view of Taskin et al. (US 2017/0296720), in in view of Siess et al (US 2020/0330666; herein referred to as Siess II).
In re claim 6, the proposed combination does not yield
wherein the conical member comprises two or more channels joining at a central hollow.
Siess II also discloses a blood pump (FIG. 2a) with an impeller (31), rotatable piece (32, 37) and a drive unit (4). Siess II further discloses the drive unit being made out of six posts (FIG. 3: 40) that join together to form a central hollow (FIG. 5: 54; [0074]).
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 blood pump of the proposed combination, to include wherein the conical member comprises two or more channels joining at a central hollow, as taught by Siess II. One would have been motivated to make this modification to improve the customization of the drive unit, as the dimension of posts can be adjusted to a desired drive unit performance (Siess II, [0020]).
In re claim 7, the proposed combination yields (all mapping directed to Siess II) wherein the conical member comprises a segmented frustoconical shape (FIG. 3, FIG. 5).
In re claim 8, the proposed combination yields (all mapping directed to Siess)
wherein, during operation of the blood pump, blood flows through the flow tube within the primary impeller, and passes through the two or more channels (31, 35; Regarding the limitation “the two or more channels” see section Claim Rejections 112 (In re claim 8) above).
In re claim 9, the proposed combination yields (all mapping directed to Taskin)
wherein, during operation of the blood pump, the blood is driven radially outward by vanes of the secondary impeller ([0061]: “fluid driving elements” drive the blood “outwardly along the bottom surface”).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 2018/0050139), in view of Schaefer et al. (US 4,714,405), in view of Taskin et al. (US 2017/0296720), in view of Chardack (US 4,957,504).
In re claim 10, the proposed combination yields further comprising a contact-type bearing (10) in which the flow tube is disposed (see modification above (In re claim 2)).
The proposed combination does not yield further comprising a sleeve bearing in which the flow tube is disposed.
Chardack discloses an analogous blood pump, that like the proposed combination is implanted to support heart function (abstract). The blood pump includes a rotor (12) supported by a sleeve bearing (34). As seen in FIGS. 1-2 the sleeve bearing has two (FIG. 1) and in some cases three (FIG. 2) radially extending support arms (30).
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 bearing of the proposed combination to be a sleeve bearing, as taught by Chardack. One would have been motivated to make this modification because the contact-type bearing of the proposed combination and the sleeve bearing of Chardack are functionally equivalent. Moreover, one of ordinary skill in the art would have the ability to choose the type of bearing that would best meet their needs.
In re claim 11, the proposed combination yields (all mapping directed to Siess)
wherein the sleeve bearing comprises one or more arms (15) extending outwardly to attach to a shroud (inner surface of 2; Examiner notes that under the broadest reasonable interpretation “a shroud” is being interpreted as a cover).
In re claim 12, the proposed combination yields (all mapping directed to Siess), wherein the primary impeller is disposed in the shroud (FIG. 1A).
In re claim 13, the proposed combination yields (all mapping directed to Siess),
wherein one or more bearing interfaces of the sleeve (points along top of 10 that contact 15, illustrated in FIG. 1A as a darkened half circle) are not perpendicular to a longitudinal axis (9) of the sleeve bearing.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stotz et al. (US 12,390,633) discloses a blood pump (col. 3, line 65) that includes a flushing mechanism to ensure sufficient heat is being dissipated from the pump (col. 1, line 66- col. 2 line 5).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796