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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-18, drawn to a defibrillation/cardioversion electrode device with spaced apart electrodes.
Claims 19-20, drawn to a method of selectively activating electrodes.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The method of claim 19 using selective activation of electrodes can be practiced differently from the apparatus claims 1 and 18.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve 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 restriction 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 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.
During a telephone conversation with Ashley Preston-Hinez on 8/27/2026 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 1208333 B2, claims 1-22 of US 9855414 B2, claims 1-18 of US 10661073 B2, claims 1-21 of US 11534603 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) 1-2, 4-7, 11-13, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (US 2013/0150942 A1) In view of Dahl (US 5455202), further in view of Scheiner (US 6321122 B1).
Regarding claims 1 and 12, Ostroff discloses a system comprising: an extravascular implantable lead comprising: a proximal portion comprising a connector configured to connect the extravascular implantable lead to an implantable medical device (eg. Fig. 1, Para. 44-45 with header 18); and a distal portion configured for extravascular implantation and anterior cardiac placement (eg. Para. 51, 54-57, claim 1), the distal portion comprising: a first electrode configured to deliver defibrillation or cardioversion shock therapy (eg. Para. 2, 9-10, 44-45, 51, 61, 78-83 electrodes 14 and 14’ or 50 and 52); a second electrode configured to deliver defibrillation or cardioversion shock therapy (eg. Para. 2, 9-10, 44-45, 51, 61, 78-83 electrodes 14 and 14’ or 50 and 52), but does not disclose the second electrode being spaced from the first electrode by a distance within a range from 1 centimeter (cm) and 3 cm; and a third electrode located between the first electrode and the second electrode configured to one or more of sense cardiac electrical signals or deliver pacing.
Dahl teaches a defibrillation electrode system that has 3 electrodes spaced by at least 1.5 cm (eg. Col. 2, Ln. 29-45, Col. 4, Ln. 65 – Col. 5, Ln. 8, Col. 9, Ln. 30-51, claim 1).
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 invention of Ostroff with the electrode distancing as taught by Dahl to provide the predictable result of improving electrode performance in terms of reduced impedance and uniformity of electrical field (eg. Dahl, Col. 9, Ln. 20-31).
Scheiner teaches a defibrillation device with a pacing lead for pacing and sensing (eg. Col. 5, Ln. 15 – Col. 7, Ln. 15 electrode 161: atrial sensing and pacing electrode).
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 invention of Ostroff and Dahl with the third sensing/pacing electrode as taught by Scheiner since defibrillation and cardioversion/sensing electrodes being used in the body are commonly known in the art (eg. Scheiner, Col. 1, Ln. 20 – Col. 3, Ln. 14).
Regarding claims 2, and 13, the combined invention of Ostroff, Dahl, and Scheiner discloses the first electrode and the second electrode are configured to be activated concurrently to form a common anode or a common cathode (Eg. Dahl, Col. Col. 2, Ln. 28 – 45, Col. 3, Ln. 30-50, Col. 5, Ln. 65 – Col. 6, Ln. 20).
Regarding claims 4 and 15, the combined invention of Ostroff, Dahl, and Scheiner discloses the first electrode comprises a first segment of a defibrillation coil and the second electrode comprises a second segment of the defibrillation coil (eg. Dahl, Col. 9, Ln. 9-20, claim 1).
Regarding claims 5 and 16, the combined invention of Ostroff, Dahl, and Scheiner discloses the distal portion of the extravascular implantable lead further comprises a fourth electrode on an opposite side of one of the first electrode or the second electrode from the third electrode, wherein the extravascular implantable lead is configured to sense the cardiac electrical signals via the third electrode and the fourth electrode (eg. Scheiner, Col. 5, Ln. 15-46).
Regarding claims 6 and 17, the combined invention of Ostroff, Dahl, and Scheiner discloses the distal portion of the extravascular implantable lead further comprises a fourth electrode on an opposite side of one of the first electrode or the second electrode from the third electrode, wherein the extravascular implantable lead is configured to deliver cardiac pacing via the third electrode and the fourth electrode (eg. Scheiner, Col 5, Ln. 15-46, Col. 6, Ln. 22-63).
Regarding claims 7 and 18, the combined invention of Ostroff, Dahl, and Scheiner discloses the distance is no greater than 2 cm (eg. Dahl, Col. 2, Ln. 29-45, Col. 4, Ln. 65 – Col. 5, Ln. 8, Col. 9, Ln. 30-51, claim 1).
Regarding claim 11, the combined invention of Ostroff, Dahl, and Scheiner discloses the system further comprises the implantable medical device (eg. Ostroff, Para. 45-46).
Claim(s) 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (US 2013/0150942 A1) In view of Dahl (US 5455202), further in view of Scheiner (US 6321122 B1), further in view of Brown (US 2005/0021093 A1).
Regarding claim 3, and 14, the combined invention of Ostroff, Dahl, and Scheiner discloses the invention of claim 1, but does not disclose first electrode and the second electrode are configured to be activated individually.
Brown teaches a defibrillation electrode system with multiple spaced electrodes that can be selectively activated (eg. Para. 17, 20, 24).
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 invention of Ostroff, Dahl, and Scheiner with the selective separate activation of Brown to provide the predictable result of optimizing treatment arrhythmias (eg. Brown, Para. 17, 20, and 24).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (US 2013/0150942 A1) In view of Dahl (US 5455202), further in view of Scheiner (US 6321122 B1), further in view of Schuelke (US 5755742).
Regarding claim 8, the combined invention of Ostroff, Dahl, and Scheiner discloses the invention of claim 1, but does not disclose a length of each of the first electrode and the second electrode is within a range from 2 cm to 5 cm.
Schuelke teaches a cardioversion/defibrillation electrode that has electrodes to be about 5 cm in length (eg. Col. 7, Ln. 19 – Col. 8, Ln. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Ostroff, Dahl, and Scheiner to have the electrodes be 5 cm in length since it’s a common size used in the art (eg. Col. 7, Ln. 29-45).
Regarding claim 9, the combined invention of Ostroff, Dahl, Scheiner, and Schuelke discloses a length of the distal portion is less than or equal to 10 cm (eg. Col. 7, Ln. 57 – Col. 8 Ln. 16).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff (US 2013/0150942 A1) In view of Dahl (US 5455202), further in view of Scheiner (US 6321122 B1), further in view of Mehra (US 5342414).
Regarding claim 10, the combined invention of Ostroff, Dahl, and Scheiner discloses the invention of claim 1, but does not disclose a distance is a first distance, wherein a second distance between the third electrode and one of the first electrode or the second electrode is within a range from 2 millimeters and 1.5 cm.
Mehra teaches a defibrillation electrode with interelectrode spacing of about 0.5 cm (eg. Col. 1, Ln. 44 – Col. 2, Ln. 15, claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Ostroff, Dahl, and Scheiner with the spacing as taught by Mehra since the amount of spacing is commonly used in the art (eg. Col. 1, Ln. 44 – Col. 2, Ln. 15).
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 5712705625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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