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 .
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 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.
Status of Claims
Claims 1-12 are pending and under consideration for patentability.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 21 November 2024 has been acknowledged and considered by the Examiner.
Applicant should note that the large number of references in the attached IDS have been considered by the Examiner in the same manner as other documents in Office search files are considered while conducting a search of prior art. See MPEP 609.05(b). Applicant is requested to direct the Examiner to any references in the IDS which may be of particular relevance to the presently claimed invention in response to this Office Action.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel (US 2014/0223724 A1) in view of Carrier et al. (US 2005/0250975 A1).
Regarding claim 1, Scheckel describes an apparatus comprising a blood pump ([0034]) comprising an impeller configured to pump blood through a subject’s body ([0058]) and a frame disposed around the impeller, wherein, in a radially-non-constrained configuration of the frame, the frame defines a proximal conical portion and a cylindrical portion disposed distally to the proximal conical portion (figure 2, housing 8 with conical and cylindrical sections as shown).
Regarding claim 1, Scheckel does not explicitly disclose wherein the blood pump is configured such that, during at least some of the operation of the blood pump, a first portion of the impeller is disposed within the proximal conical portion of the frame. However, Carrier also describes a blood pump, including wherein the blood pump is configured such that, during at least some of the operation of the blood pump, a first portion of an impeller is disposed within a proximal conical portion of a frame ([0116], [0119]). As Carrier is also directed towards blood pumps and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to position the impeller described by Scheckel such that it was disposed within a conical section, in a manner similar to that described by Carrier, as doing so advantageously allows the resulting impeller to assume a smaller profile during deployment and startup.
Regarding claim 2, Scheckel describes wherein the frame further defines a distal conical portion disposed distally to the cylindrical portion (figure 2).
Regarding claims 3 and 6, Scheckel describes wherein the impeller comprises at least a portion along which a diameter of the impeller increases toward a location along the impeller at which a span of the impeller is at its maximum ([0067]), and Carrier describes wherein the blood pump is configured such that at least some of the portion of the impeller along which the diameter of the impeller increases (as described by Scheckel) is disposed within the conical portion of the frame during at least some of the operation of the blood pump ([0116], [0119]).
Regarding claim 4, Scheckel describes wherein the blood pump is configured such that, during at least some of the operation of the blood pump, a second portion of the impeller is disposed within the cylindrical portion of the frame ([0067], figure 2).
Regarding claim 5, Scheckel describes wherein throughout the operation of the blood pump, at a location at which a span of the impeller is at its maximum, the impeller is configured to be disposed within the cylindrical portion of the frame ([0067], figure 2).
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel in view of Carrier, further in view of Schwammenthal et al. (US 2016/0022890 A1).
Regarding claim 7, Scheckel in view of Carrier suggests the apparatus according to claim 1, but neither Scheckel nor Carrier explicitly disclose wherein the frame comprises struts that are shaped to define cells, and wherein a density of the struts increases from the proximal conical portion to the cylindrical portion. However, Schwammenthal also describes an a blood pump ([0012]), including the use of a frame which comprises struts that are shaped to define cells ([0091] - [0092]), wherein a density of the struts increases from a proximal conical portion to the cylindrical portion (figure 10A). As Schwammenthal is also directed towards blood pumps and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate the use of struts, similar to those described by Schwammenthal, when using the device described by Scheckel and Carrier, as doing so advantageously enhances the structural integrity of the resulting device.
Regarding claim 8, Scheckel describes wherein the frame further defines a distal conical portion disposed distally to the cylindrical portion (figure 2), and Schwammenthal describes wherein the density of the struts increases from the distal conical portion to the cylindrical portion
Regarding claim 9, Schwammenthal describes wherein, within the cylindrical portion of the frame, a strut density of the frame is constant (figure 10A).
Regarding claims 10-12, although Scheckel, Carrier, and Schwammenthal do not explicitly disclose wherein the width of each of the cells within the cylindrical portion as measured around the circumference of the cylindrical portion is less than 2 mm, between 1.4 mm and 1.6 mm, and/or between 1.6 mm and 1.8 mm, the Examiner respectfully submits that, as Schwammenthal describes that the maximum diameter of the frame can be 10 mm ([0768], inventive concept 67), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the struts and the widths of the cells therein as necessary in order to maintain the structural integrity of the frame while ensuring that it is appropriately sized, as doing so would be a matter of changing the size and/or proportion of the struts without changing the performance of the overall device (please see MPEP 2144.04).
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,186,545 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a blood pump comprising an impeller and a frame disposed around the impeller, wherein the frame defines a proximal conical portion and a cylindrical portion, and wherein the blood pump is configured such that at least a portion of the impeller is disposed within the proximal conical portion of the frame during operation. A brief, but non-exhaustive matching of the pending claims and the issued claims is provided via the table below.
U.S. Application No. 18/955,121
Pending Claims
U.S. Patent No. 12,186,545 B2
Issued Claims
1
1
2
2
3
3
4
1
5
4
6
3
7
5
8
6
9
7
10
8
11
9
12
10
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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