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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/2026 has been entered.
Response to Arguments
As a preliminary matter, the applicant requested a full citation to the Oxford Dictionary definition of “lumen.” The definition can be found at https://www.oed.com/dictionary/lumen_n and a copy of the definition is included with this Office Action.
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive. The applicant argues that Lamson does not teach or suggest puncturing the interventricular wall. As previously outlined by the Examiner, Lamson explicitly discloses that the method can be used to advance the penetrating catheter within a heart chamber to penetrate and access the wall of the chamber, which would include a right ventricle (par. 0039). Furthermore, Lamson equates a blood vessel with the atrium of the heart and states that the penetrating catheter can be placed in any vessel or cavity in par. 0031. Lamson provides direct teaching of placing a penetrating catheter in a chamber of heart and penetrating that tissue to reach a target zone within that tissue (par. 0031). So Lamson clearly teaches penetrating ANY heart wall in order to access ant location within the heart wall.
For a teaching of the specific target area of an interventricular septal wall in the right ventricle, the Examiner introduced the Casavant reference. Figure 1 of Casavant shows the lead passing through the intraventricular septal wall of the right ventricle in order to place the electrodes in the interventricular septal wall to extend along the left ventricular endocardial wall. Therefore, using the penetration method of Lamson in order to access the specific location of Casavant would require penetrating/puncturing the interventricular wall in order for the electrode to be placed within the interventricular septal wall to extend along the left ventricular endocardial wall.
Applicant further argues that there is a lack of motivation to combine the references. The Examiner respectfully disagrees. Again, Lamson is disclosing a generic method that can be used to puncture the wall of any body lumen desired for the lead/catheter to be implanted within a myocardium, as disclosed in par. 0013, 0037-0038, 0046 and claim 7. Lamson suggests the method can be used for any location. Using the method in the specific location disclosed by Casavant has the benefit of sensing signals from the electrodes and properly timing stimulation of both the left and right bundle branches to effectively cause contraction of the ventricles (par. 0049 for motivation). The fact that Casavant may use a different method is irrelevant. Lamson is not modifying Casavant, but rather Casavant is modifying Lamson. The disclosed benefit of the specific location disclosed by Casavant would be a benefit of using the method of Lamson in that particular location.
As described previously and again below, Lamson discloses delivering a delivery catheter 10 and a penetration element 14 disposed in the delivery catheter to any suitable cardiac location, including any chamber of the heart (par. 0031-0032, 0039-0040). The penetration element 14 then punctures the wall of the heart to form an opening and enters the myocardium (par. 0031-0032, 0039-0040). A guidewire 16/GW2 is advanced through the delivery catheter and the opening an into the myocardium before retracting the penetration element 14 (par. 0031-0032, 0039-0040). An implantable medical lead 18/82 is delivered over the guidewire to the myocardium to extend along the myocardial wall to position an electrode 20/84 in the myocardium to stimulate tissue (par. 0033, 0040).
The current claims DO NOT recite using a single guidewire to penetrate the septal wall. The claims explicitly recite that there is a penetration element that punctures the wall, and then a separate guide element is advanced into the opening. These limitations are mapped out above with regards to Lamson. Claim 11 does not even require a guide wire, as argued by the applicant.
Applicant provides no evidence of why a heart chamber would not be a lumen. The Examiner has provided evidence as to why the BRI of lumen would include a heart chamber.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The applicant has not attempted to argue why the COMBINATION of the references would not suggest the invention to cone of ordinary skill in the art.
The applicant’s amendments and associated arguments with respect to claim 17 have been fully considered and are persuasive. The 103 rejection of claim 17 has been withdrawn.
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.
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 11-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lamson et al. (US 2004/0015193, hereinafter Lamson) in view of Casavant et al. (US 2020/0009380, hereinafter Casavant).
Regarding claims 11-16, Lamson discloses a method comprising delivering a delivery catheter 10 and a penetration element 14 disposed in the delivery catheter to any suitable cardiac location, including any chamber of the heart (par. 0031-0032, 0039-0040). The penetration element 14 then punctures the wall of the heart to form an opening and enters the myocardium (par. 0031-0032, 0039-0040). A guidewire 16/GW2 is advanced through the delivery catheter and the opening an into the myocardium before retracting the penetration element 14 (par. 0031-0032, 0039-0040). An implantable medical lead 18/82 is delivered over the guidewire to the myocardium to extend along the myocardial wall to position an electrode 20/84 in the myocardium to stimulate tissue (par. 0033, 0040).
While Lamson discloses the applicant’s basic invention, and explicitly states the method can be used to place the lead in any myocardial tissue, the reference is silent as to puncturing the interventricular septal wall from the right ventricle in order to place an electrode in the left ventricular myocardium. Attention is directed to Casavant, which discloses a method of implanting a cardiac electrode, and thus is analogous art with Lamson. Casavant discloses placing a lead through the interventricular septal wall via the right ventricle in order to place one or more electrodes 112A in the left ventricular myocardium and one or more proximal electrodes 112B in the right ventricular myocardium (figure 1 and par. 0049) in order to sense electrical activity of the left ventricle and right ventricle and time stimulation of the left and right bundle branches (fig. 2, par. 0049, 0053-0054). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Lamson to be implanted specifically through the interventricular septal wall from the right ventricle in order to place an electrode in the left ventricular myocardium and a proximal electrode in the right ventricular myocardium in order to sense signals from the electrodes and properly time stimulation of both the left and right bundle branches to effectively cause contraction of the ventricles (par. 0049 for motivation).
Regarding claim 18, as seen in figures 1a-4b, at least a portion of the lead is parallel to the cardiac wall.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796