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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/12/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8, 9, 15 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claims 8, 9, 15 and 20, the examiner was unable to find support in the original disclosure for a transeptal structure in the form of a clip. The only mention of a clip is in paragraph 0055 and referring to an unrelated feature. If a “clip” requires or implies some sort of functionality or structure beyond a “dip,” this does not appear to be supported by the original disclosure.
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 10-15 and 20 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 claims 10, 11, 12 and 14, the limitations drawn to left and right electrodes lack antecedent basis. It is unclear whether this language refers to the first and second electrodes, or something else. The examiner is considering the language to refer to the first and second electrodes for prior art purposes, but clarification is respectfully requested.
In regards to claim 20, “the electrode” lacks antecedent basis. It is unclear whether this is referring to the first electrode, second electrode, both electrodes, or either electrode.
The remaining claims are rejected by virtue of their dependency.
Allowable Subject Matter
Claims 1-20 avoid the prior art, but claims 8-15 and 20 remain rejected under section 112 above. The closest prior art is to McGee (US 5,855,592). Although McGee generally discloses a lead system for providing electrodes to the right and left septal wall (Figs. 13 and 14), McGee does not disclose or suggest that any of the electrodes both extend along the atrial septum and are in electrical contact with the endocardium, or that the “structure” of McGee meets the requirements of claim 1. For instance, the structure 124 of McGee includes a body 126 passing through the septum and splines 132 that engage the two sides of the septum. Not only does McGee appear to lack the configuration of a lead comprising electrodes in combination with the “structure” having the claimed functionality of claim 1 (i.e., as part of the “structure,” McGee’s electrodes are not part of a separate lead element, but instead appear to be part of the splines), but also, McGee fails to disclose that the first and second electrodes extend away from the structure rather than being part of the structure itself (note Fig. 14 showing the electrodes with placement part-way along the splines and not extending from them). Taken as a whole, the preponderance of the evidence in the record indicates that McGee, taken alone or in combination with the remaining prior art, fails to fairly anticipate or render unpatentable the subject matter of claim 1.
Response to Arguments
Applicant's arguments filed 5/12/2026 have been fully considered but they are not persuasive in part, moot in part, and persuasive in part.
In regards to the prior art, please see above. The amendments to the claims overcome the prior art.
In regards to the rejections under section 112(b), please see the updated rejections due to amendments correcting several issues from the last Office action and introducing new issues under section 112(b).
In regards to the previous rejection of claims 8, 9, 15 and 20 under section 112(a), the examiner respectfully maintains the previous grounds of rejection. Applicant argued that recitation of a “dip” in the instant application (and the priority document from which the application claims domestic benefit) is an obvious typographical error that was recited as a “clip” in a previous application. Applicant notes that “U-shaped clip” was intended and was recited in a corresponding patent application (PCT publication no. PCT/US2020/063664). Referring to MPEP 2163.07, an amendment to correct obvious errors does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. See In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971). In this case, the original claims, original disclosure, and provisional application to which this application claims benefit (US 63/312,773) all make several references to a “U-shaped dip” and no references to a “U-shaped clip.” Further, Fig. 2I depicts the structure as causing the electrodes to extend along the right atrium, “dip down” to engage the right atrial septum, pass through the septum, and then extend up into the left atrium to engage the left septal wall and left atrium. Accordingly, the examiner’s position is that this configuration can fairly and reasonably be described as a “U-shaped dip,” and so an artisan of ordinary skill would not read these original claim limitations in light of the original specification and recognize the existence of an obvious error, let alone recognize that this is an obvious error with the substitution of “U-shaped clip” being the appropriate correction. Applicant notes that a “corresponding” patent application makes use of the phrase “U-shaped clip,” but it is not clear how this PCT application “corresponds” in any legally cognizable way to the instant application. Review of the file history does not indicate that this PCT application is related by priority in any way or has been incorporated by reference into the instant application. If “dip” and “clip” are of co-extensive scope, it is unclear why such differing language would be appropriate; and if “dip” and “clip” are not of co-extensive scope, there does not appear to be any basis to include this new language under section 112(a). Accordingly, the examiner respectfully maintains this basis of rejection.
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.
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, 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
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