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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/16/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4, 9-13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flach et al. (US 2006/0020317, hereinafter Flach).
Regarding claims 1, 2, and 15-17, Flach discloses a catheter that is configured for neurostimulation and pain therapy, if so desired by a user. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The catheter comprises a longitudinally extended catheter shaft, at least one stimulation electrode 24 arranged on the catheter shaft, and at least one anchor element 14 secured to the catheter shaft (par. 0074, figures 15a-15b). The anchor element 14 is of a size and shape that is configured to be anchored to tissue that surrounds the catheter shaft, and the entirety of anchor element 14 is galvanically dissolvable under action of a DC voltage, inherently delivered from a signal generator (par. 0071). Alternatively, figure 3 shows an anchor 14 made of galvanically dissolvable material such that when portion 14 dissolves the catheter is released from anchorage (par. 0060). Alternatively, figure 14 shows an anchor element 12 with 1 barb shaped anchor element 12 with an anchor portion 28 and a securing portion 14, such that when portion 14 galvanically dissolves, catheter is released from anchorage (par. 0070).
Regarding claim 3, alternatively, the anchor element can be considered element 12 which comprises an anchor portion 28 that is configured to be anchored to tissue that surrounds the catheter shaft, and comprises securing portion 14 that is galvanically dissolvable under action of a DC voltage (par. 0071).
Regarding claims 9-10, the anchor element 12 can comprise expandable helix/barb 40 and securing portion 42, made of the galvanically dissolvable material (fig. 18a-18b and par. 0074).
Regarding claims 10-13, Flach discloses an embodiment with an expandable anchor element comprising barbed portions 40 and dissolvable portion 42 which holds the barbed portions against the catheter body until the portion 42 dissolves due to moisture in the body, and which may be accelerated by the application of a DC voltage (figures 19a-19b and par. 0071-0072, 0075).
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.
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Flach in view of CA 2677136 (hereinafter Canada).
Flach discloses the applicant’s basic invention, including a dissolvable material made of magnesium alloy, such material also being galvanically dissolvable. Flach is silent as to also using iron, nickel, tin, copper, and/or zinc in addition to or in lieu of magnesium alloy. However, the Examiner takes Official Notice that all of iron, nickel, tin, copper, and/or zinc are inherently galvanically dissolvable materials. In other words, that is an innate property of those materials. Furthermore, Canada discloses implantable medical devices, and thus is analogous art with Flach. Canada discloses that implants can be made of biodegradable metals, including iron, nickel, tin, copper, and/or zinc (see page 3, page 6, page 22). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Flach to include iron, nickel, tin, copper, and/or zinc as the anchor material, as Canada discloses the materials to be dissolvable in the body and therefore their use would not change the overall purpose of functionality of Flach.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Flach.
Flach discloses the applicant’s basic invention, as seen above in paragraph 9, where a medical adhesive 42 is utilized, but is silent as to the material of the adhesive being sugar. Flach also discloses that medical adhesives can be made of sugar (par. 0027). It has been held that when a reference “teaches all of the [claimed] limitations. . . . The only qualification to this statement of fact is that all of the limitations are found in two separate embodiments pictured side by side in the patent, not in one embodiment.” Applying KSR, the Federal Circuit found that it would have been obvious to combine the two embodiments since the combination was simply a “predictable variation” and “Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.” See Boston Scientific v. Cordis (Fed. Cir. 2009).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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