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
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/18/26.
Applicant's election with traverse of the restriction in the reply filed on 8/1/26 is acknowledged. The traversal is on the ground(s) that there is no serious search burden for the examiner and that the claims include the same core inventive concepts of a sheath construction. This is not found persuasive because as seen by the different areas of classification set forth in the restriction, the groups are searched in different areas and/or are recognized divergent subject matter. Therefore, there is a serious search burden. While the applicant argues that the same core inventive concept of a sheath is set forth in each of the independent claims, the core concept of the sheath is not a novel or unobvious element.
The requirement is still deemed proper and is therefore made FINAL.
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 1-3 and 5-7 are rejected under 35 U.S.C. 102a1 as being anticipated by Waldhauser et al (2004/0122360). Waldhauser discloses the claimed elements as follows:
--an inner liner (e.g. element 44, etc.)
--an outer jacket (e.g. element 40/42/45/34, etc.)
--a reinforcement braid between the inner liner and outer jacket (e.g. element 28, figure 2, etc.)
--a marker band over a portion of the braid, positioned between the braid and outer jacket (e.g. element 62, paras. 20, 61, 65, figures 1, 5, etc.), and the sheath having an outer diameter of less than 0.067 inches (e.g. para. 59, etc.) for use in delivering a lead to a dorsal root ganglion (e.g. para. 2, etc.; in addition, it is capable of meeting these functional use recitations due to its size and flexibility).
For claim: 2, marker band in curved section (e.g. figures 1, 5, curved section starting at 51 or 52, to 34, etc.); 3, outer jacket made of first softer material in curved section and stiffer material in straight section, 50 (e.g. paras. 47, 53-55 etc.); 5, inner liner has a first thickness less than 40% of outer jacket (e.g. paras. 57, 59; inner liner having diameter of 0.61 mm, wall thickness of 0.013 mm, while outside diameter of sheath being 1.65 mm, leaving outer jacket to be approximately 1.04 mm thick at different sections, such as at end 34, etc.); 6, steel wires at 38-52 picks per inch (e.g. stainless steel at 45 picks, paras. 52, 72, etc.); 7, braid at 1 over 1 (e.g. paras. 52, 69, single braid using 3 wires, etc.);
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.
Claims 4, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser et al. Waldhauser discloses the claimed invention as described above having a radiopaque marked, different sheath wall thicknesses in different sections, and using different polymer materials for the inner and outer liner, but does not disclose the use of a wall thickness of the sheath being less than 0.008 inches (e.g. claim 4), the polymer inner or outer jacket doped with BaSO4 (barium sulfate, claim 8), and the marker band having a density greater than 6.45 g/cm3 (claim 9). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system and method as taught by Waldhauser, with a wall thickness of the sheath being less than 0.008 inches, the polymer inner or outer jacket doped with BaSO4 (barium sulfate), and the marker band having a density greater than 6.45 g/cm3, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of: providing different wall thicknesses to provide a stiffer or more flexible sheath for delivery of the lead to different areas of the body; allowing the sheath or inner/outer liner to maintain its flexibility and shape retention, and/or allow the sheath to be seen during implant due to the radiopacity of barium sulfate; providing excellent fluoroscopic visualization of the marker band to know where the sheath is located in the body. In the alternative for claims 4 and 9, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system and method as taught by Waldhauser with a wall thickness of the sheath being less than 0.008 inches and the marker band having a density greater than 6.45 g/cm3, because Applicant has not disclosed that the sheath being less than 0.008 inches and the marker band having a density greater than 6.45 g/cm3 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 different sheath wall thicknesses and radiopaque marker band as taught by Waldhauser, because it provides different stiffnesses and flexibilities to the sheath to allow it to be used in different areas of the body, and a marker that is radiopaque and can allow the physician to guide the sheath to the proper areas of the body to implant the lead. Therefore, it would have been an obvious matter of design choice to modify Waldhauser to obtain the invention as specified in the claim(s).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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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/George R Evanisko/Primary Examiner, Art Unit 3792 9/28/26
