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/Restrictions
Applicant’s election without traverse of Group 2, claims 4-10 in the reply filed on February 4, 2026 is acknowledged. Currently claims 1-10 are pending in this application with claims 1-3 withdrawn from consideration.
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.
Claims 4-6 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bornzin (US 2013/0016740).
Regarding claim 4, Bornzin discloses an intracardiac device comprising (e.g. as shown in Figures 3A and 4C) one electrode (e.g. electrode 318) and at least two tines attached at a distal end of the intra-cardiac device adjacent the electrode (e.g. fixation mechanisms 430, 431), wherein each of the at least two tines has a distal end in form of a hook with the furthest distal end section of the tine pointing inwards, is pivotable outwards around a bending point at its proximal end and/or bendable, wherein the at least two tines are further adapted to pivoted outwards and/or bent outwards when the at least two tines are pressed against the tissue of a patient's heart at an anchoring region, thereby the distal ends of the at least two tines penetrate into the tissue, and- to bunch a wall segment of the tissue and to pull this wall segment towards the electrode when the intra-cardiac device is moved a pre-defined distance back from the anchoring region (e.g. distal region 435 of the fixation mechanism as shown in Figure 4C and [0098]). Examiner notes that the claims are apparatus claims and as such need only be capable of performing the functional use limitations of penetrating the tissue and bunching a wall segment of the tissue.
Regarding claim 5, Bornzin additionally discloses wherein at the distal end of the intra-cardiac device the electrode is located at a central position and the proximal ends of the at least two tines are located at a circumference around the electrode (e.g. as shown in Figure 4C).
Regarding claim 6, Bornzin additionally discloses wherein the length of the at least two tines is in the range of 2 mm to 10 mm and/or the length of the electrode is equal to or less than 5 mm, wherein the each length is determined into the direction of a longitudinal axis of the intracardiac device (e.g. the device as shown in Figure 4C is shown to penetrate the wall between the atrium and the ventricle which will necessarily be between 2 and 10 mm).
Regarding claim 8, Bornzin additionally discloses wherein the distal end section of the at least two tines is curved such that its furthest end points towards the electrode (e.g. as shown in Figure 4C).
Regarding claim 9, Bornzin additionally discloses wherein the distal section or more of the at least two tines comprise one or more barbs (e.g. hooks as shown in Figure 4C).
Regarding claim 10, Bornzin additionally discloses wherein the tines comprise a proximal section and a distal section, whereby the proximal section of the is straight and parallel to the longitudinal axis of the intra-cardiac device and the distal section is formed as a hook (e.g. straight and hook sections as shown in Figure 4C).
Claim Rejections - 35 USC § 103
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bornzin.
Regarding claim 7, Bornzin discloses the claimed invention but does not disclose expressly wherein the diameter of the distal end of the at least two tines is in the range of 1 mm to3 mm. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the tines as taught by Bornzin with the desired tine diameters, because Applicant has not disclosed that such a diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the tines as taught by Bornzin, because it provides a reliable fixation mechanism and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Bornzin to obtain the invention as specified in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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