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 .
Election/Restriction
This application contains claims directed to the following patentably distinct species
Species 1: Claims 82-92.
Species 2: Claims 93-102.
Species 3: Claims 103-113.
Species 4: Claims 114-120.
The species are independent or distinct because they are different embodiments/devices. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are generic.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them 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 species 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 species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Geoffrey Dekleine on 4/8/2026 a provisional election was made without traverse to prosecute the invention of Species 1, claims 82-92. Affirmation of this election must be made by applicant in replying to this Office action. Claims 93-120 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 82-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 12053623 and 1-62 of US Patent No. 11179557 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims read on the application claims.
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 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.
Claim(s) 82-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Georges (US 2022/0323744 A1).
Regarding claim 82, Georges discloses A modular implantable medical device (eg. Para. 146-153), comprising:- a functional unit intracorporeally implantable (eg. Para. 36, 43, 174, claim 9);- a control wire configured to attach to and project from the functional unit (eg. Para. 272, 326, 516, 536, 548, 549, 568, 594-595); and- a docking unit configured to intracorporeally dock the functional unit (eg. Para. 146, 220, 272-278, 319-327, Fig. 10, 32-34, 37, Para. 517, docking unit 602), wherein at least one of the control wire and the docking unit is further configured to be moved relative to the other one of the control wire and the docking unit for intracorporeally docking the functional unit and the docking unit together, when the control wire is attached to the functional unit (eg. Para. 272-278, 319-327, 1163-1183, 1191-1200, 1201-1207).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of Georges to have alternative equivalent ways to connect the control wire and functional units with the central docking unit as desired.
Regarding claim 83, Georges discloses the control wire is extracorporeally pullable for intracorporeally docking the functional unit to the docking unit, and is extracorporeally pushable for intracorporeally undocking the functional unit from the docking unit (eg. Para. 278, 326, 421, 460, 532, 545, 564).
Regarding claim 84, Georges discloses the functional unit is intracorporeally operable, and the control wire is configured for the functional unit attached to the control wire to be electrically operated through the control wire (eg. Para. 516, 548, 567, 594, 616).
Regarding claim 85, Georges discloses one or more of the functional units for a total of two or more functional units, and one or more of the control wires for a total of two or more control wires; the two or more functional units being intracorporeally implantable; each one of the two or more control wires being configured to attach to and project from a respective one of the two or more functional units; the docking unit being further configured to intracorporeally dock the two or more functional units; and at least one of the docking unit and the two or more control wires being further configured to be moved relative to the other one of the docking unit and the two or more control wires for intracorporeally docking the two or more functional units and the docking unit together, when the two or more control wires are respectively attached to the two or more functional units (eg. Fig. 7, Para. 272-277, 319-327, 369-377, 410-421, 516-517).
Regarding claim 86, Georges discloses the two or more functional units are arrangeable substantially coaxially relative to each other when undocked from the docking unit and enclosed in a sheath, and are substantially transversally arranged one next to another when docked to the docking unit (Eg. Para. 9, Para. 272-278, 319-327, 369-377, 410-421, 452-461, 482-484, 532-542).
Regarding claim 87, Georges discloses the docking unit is electrically non- powerable (eg. 319-327, 369-377, 410-421, 452-461, 482-484, 532-542, mechanical coupling).
Regarding claim 88, Georges discloses the docking unit and the functional unit are free from magnetic interaction therebetween for intracorporeally operating the functional unit (eg. 319-327, 369-377, 410-421, 452-461, 482-484, 532-542, mechanical coupling using inter-receiving-surface portions).
Regarding claim 89, Georges discloses the docking unit is non-expandable (eg. Para. 146).
Regarding claim 90, Georges discloses the docking unit is intracorporeally non- anchorable by itself (eg. Para. 319-327, 369-377, 410-421, 452-461, 482-484, 532-542, using wires).
Regarding claim 91, Georges discloses an anchor configured to couple to the docking unit; the anchor including an unanchored configuration for intracorporeal delivery of the docking unit, and an anchored configuration for intracorporeally anchoring the docking unit; the functional unit being intracorporeally non- dockable to the docking unit coupled to the anchor in the unanchored configuration; and the functional unit being intracorporeally dockable between the docking unit and the anchor coupled to the docking unit and in the anchored configuration (eg. Para. 410-421, 474-484, 503, 507-517, 532, 533, 542-549).
Regarding claim 92, Georges discloses the functional unit is a transcatheterly implantable blood pump, and the control wire is an electrical wire configured for the transcatheterly implantable blood pump to be electrically operated therethrough (eg. Abstract, Para. 21, 26, 47, 525, 531, 540, 542, 557, 578, 606).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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, Carl Layno can be reached at 571-272-4949. 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J LAU/Examiner, Art Unit 3796
Prosecution Insights