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 .
Response to Arguments
Applicant’s arguments, see “remarks,” filed 1/28/2026, with respect to the prior art rejections in view of Bornzin have been fully considered and are persuasive. The prior art rejections in view of Bornzin have been withdrawn, but new rejections in view of Marshall are set forth below.
Applicant's arguments filed 1/28/2026 in view of the section 112 rejections have been fully considered but they are not persuasive. In regards to claim 40, Applicant argued that, when considered in light of the specification, the terms “vertical portion” and “closer to” are clear. However, the examiner respectfully maintains that these limitations are vague without some basis of comparison set forth in the claim. For instance, the term “vertical” appears to be wholly dependent on the orientation of the system as a whole/orientation of the patient, and so does not appear to limit the structure actually set forth in the claim. In other words, the claim does not establish that some portion is “horizontal” and some other portion is “vertical” with respect to that portion, but just that some portion is “vertical” (i.e., completely dependent on the subjectively-chosen orientation of the lead as a whole). It is not clear that this places any structural limitation on the recited lead, and if it does, what that limitation might be. Similarly, the limitation drawn to a vertical portion being “closer to” a distal tip does not set forth the basis of comparison (i.e., “closer” than what?). Does this refer to “closer than if the bend were not there,” “closer than when being inserted,” “closer than some other element or elements,” or some other scope? Although the claims are considered in light of the specification, the claim does not reasonably set forth the metes and bounds of the structure being claimed. Similarly, the “over the electrode” limitation of claim 41 is vague because there is no relative frame of reference set forth in claim, appearing to again recite a subjectively-chosen orientation of the lead as a whole that could place any electrode over any other portion based on how a user orients the system, rendering it unclear if or how this limitation limits the apparatus set forth in the claim. Accordingly, the examiner respectfully maintains the previous rejections under section 112.
Claim Rejections - 35 USC § 112
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 40, 41 and 43-45 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 regards to claim 40, the limitation “vertical portion” is vague. Since there is no basis of comparison to any other element, it is unclear if or how “vertical” limits the claim, as this is merely dependent on the orientation of the system as a whole (i.e., any or all elements of the claim can be placed in a “vertical” position depending on how a user orients the system). Further, the phrase “closer to” is vague. As there is no basis of comparison (i.e., “closer” compared to what?), it is unclear if or how this language limits the claim.
In regards to claim 41, the phrase “over the electrode” is vague. Similar to above, placing any element of the system “over the electrode” appears to be dependent solely on how a user chooses to orient the system as a whole, and so it is unclear if or how this limitation limits any of the structure set forth in the claim.
The remaining claims are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 40, 41 and 43-44 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Marshall et al. (US 2016/0158567, hereinafter “Marshall”).
In regards to claim 1, Marshall discloses an electrical lead for implantation in a patient (Fig. 4), the lead comprising:
a distal portion (Fig. 4, portion distal to element 24a) comprising one or more electrodes (element 32b) that are configured to generate therapeutic energy for biological tissue of the patient (par. 0006); and
a proximal portion (portion of lead proximal to and including 24a) coupled to the distal portion and configured to engage a controller (via element 34, par. 0043), the controller configured to cause the one or more electrodes to generate the therapeutic energy (par. 0043).
In regards to claim 40, a proximal part includes a bend (elements 24a and 28a) to place a vertical portion (portion of lead including electrode 32a along axis “x”) of the proximal part closer to a distal tip of the lead when the lead is in a deployed configuration to facilitate contact of an electrode with biological tissue of the patient when the lead is in the deployed configuration (Fig. 4, closer than if the bends were not there).
In regards to claim 41, the bend places the vertical portion approximately over the electrode on the distal part (Fig. 4, both lie on axis “x”; vertical portion is over the electrode 32b if the lead as a whole is oriented with the distal end pointing down).
In regards to claim 43, the proximal part includes an S-shape (Fig. 4, the portion including 24a and 28 is S-shaped).
In regards to claim 44, the bend configured to increase the flexibility of the proximal part of the lead to facilitate maintaining contact with the biological tissue when the lead is in the deployed configuration (par. 0081).
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.
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Marshall in view of Truong (US 2010/0217277, hereinafter “Truong”). Marshall discloses the essential features of the claimed invention, but does not expressly disclose the proximal part including one or more grooves or holes for suturing the vertical portion to the patient. However, Truong in the same field of endeavor of implantable leads is one of many teachings of providing one or more grooves or holes for suturing the vertical portion (and all other portions of the lead) to the patient (Fig. 3, element 39; par. 0030) to provide the predictable results of a convenient feature for the implanting physician to anchor the lead body within the patient after the distal tip has been properly positioned and secured (par. 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall by providing one or more grooves or holes for suturing the vertical portion (and all other portions of the lead) to the patient to provide the predictable results of a convenient feature for the implanting physician to anchor the lead body within the patient after the distal tip has been properly positioned and secured.
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 claim 1 of U.S. Patent No. 11,998,736. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is narrower than (i.e., includes the limitations drawn to the lead with distal and proximal portions) the claim of the instant application.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,666,771. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is narrower than (i.e., includes the limitations drawn to the lead with distal and proximal portions) the claim of the instant application.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,208,260. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is narrower than (i.e., includes the limitations drawn to the lead with distal and proximal portions) the claim of the instant application.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,636,505. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is narrower than (i.e., includes the limitations drawn to the lead with distal and proximal portions) the claim of the instant application.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,296,175. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the issued patent is narrower than (i.e., includes the limitations drawn to the lead with distal and proximal portions) the claim of the instant application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792