DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive.
The new limitations overcome the prior interpretation of the claims. However, even though the Khanal reference does not disclose a proximal abutment body distal to the rotor and on a proximal side of the housing wall, the Examiner believes that it would have been obvious to try multiple predictable mechanical attachment configurations to joint two ends together. In this case there are a finite number of identified, predictable solutions, a person of ordinary skill in the art will use to connect to movable structure together. See rejection below for the Examiner’s interpretation of the claims.
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 16-24 and 26-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,895,475 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both cases disclose a blood pump for insertion within a body of a patient comprising a rotor which is radially compressible and expandable and having a hub and at least one impeller blade disposed on the hub. A housing which is radially compressible and expandable by an axial stretching or axial compression and a control body passing through the hub and a housing wall. Wherein the control body is coupled to the housing distal to the rotor and comprises at least one of a distal abutment body at a distal end of the control body and a proximal abutment body distal to the rotor and on a proximal side of the housing wall. Additionally, both cases disclose wherein the distal abutment body is configured to exert a compressive force in a longitudinal direction onto the housing wall on retraction of the control body in a proximal direction and the proximal abutment body is configured to exert an axial expansion force onto the housing wall when the proximal abutment body is pushed in a distal direction.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of Toellner et al U.S. Patent No. 9,895,475 in view of Scheckel US Pub. 2012/0234411A1.
Toellner et al disclose all the structural limitations as claimed and mentions that the abutment bodies are deformable, therefore, they are also compressible, however, does not disclose that the abutment bodies are made of a foam material.
Scheckel discloses that the blood pump, including the housing and the rotor can be made of a foam material for the purpose of bringing the implant to the original state when compressed.
It would have been obvious to one ordinary skill in the art to modify the abutment bodies of the Toellner et al reference with compressible foam materials in order to bring the implant to the original state when compressed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 16, 26, 28, 30 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Khanal US Patent 7,878,967B1.
Khanal discloses a blood pump (20) for insertion within a body of a patient comprising a rotor (28) which is radially compressible and expandable (see Figs. 1 and 2) and having a hub (30) and at least one impeller blade (74) disposed on the hub (30). A housing (36) which is radially compressible and expandable by an axial stretching or axial compression and a control body (114) passing through the hub (30) and a housing wall (the perimeter of element 36). Wherein the control body (114) is coupled to the housing (36) distal to the rotor (see figure below) and comprises at least one of a distal abutment body (110) at a distal end of the control body (114).
However, Khanal does not disclose a proximal abutment body distal to the rotator and on a proximal side of the housing wall.
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Therefore, it would have been obvious to try a proximal abutment body on a proximal side of the housing wall in order to be able to create an axial expansion onto the housing for the purpose of creating a compact configuration as shown in Fig. 2 of the Khanal reference.
NOTE: as disclosed in paragraphs 63, 67 and 69, this application is using elements 25 and 26 to expand and compress the housing, therefore, there are predictable solutions to perform this task. For example, as disclosed in the Khanal reference element 110 is in contact with the outside wall of the housing (36) and at the same time, the distal abutment body (110) is connected with the control body (114). This connection usually is performed by a weld or by an adhesive or by a mechanical connection such as a threaded connection or is created by a single piece, etc… Therefore, since the distal abutment body (110) is fixedly connected to the outer wall of the housing and to the control body, the distal abutment body is capable of expanding and compressing the housing and does not require the proximal abutment body, since, the distal abutment body is fixed to the housing and the control body.
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Regarding claim 26, the invention discloses a plurality of wires.
Regarding claim 28, the reference discloses that element 114 is a guide pin.
Regarding claim 30, col. 3, lines 1-26 discloses that the control body passes through a lumen of the hub (30) and that the only part that rotates are the hub, the blades and the rotary mover.
Regarding claim 31, see Figs. 1-2 and col. 3, lines 6-8.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM 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, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 8/10/26
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