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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 14 October 2025. As directed by the amendment: Claims 1, 3-5, and 7-12 have been amended, Claim 2 has been cancelled, and Claim 21 has been added. Claims 13-20 were previously withdrawn due to a Restriction Requirement. Thus, Claims 1, 3-12, and 21 are presently under consideration in this application.
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 1, 3-12, and 21 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.
Regarding Claim 1, the claim has been amended to recite “a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen, wherein the polymeric tube defining defines a second lumen and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body”. However, neither the Specification nor Drawings as originally filed explicitly shows or suggests both “a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen” and “wherein the polymeric tube defining defines a second lumen and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body”, since this would encompass embodiments wherein the polymeric tube length is longer than the first lumen of the lead body (i.e., a polymer tube that extends only a portion of a length of a first lumen, but also extends from a proximal end to the distal end of the lead body).This particular structure is not only not shown in the Specification nor Drawings, it is further unclear as to how this would be structurally accomplished. Therefore, this is considered to be new matter. It appears that structurally, this limitation would have to specify that the first lumen must extend the entire length of the lead body. This is further evidenced by Claim 3, which states “wherein the polymeric tube extends from a proximal tip to a distal tip of the lead body”.
Appropriate correction of clarification of the new matter is required. Claims 3-12 and 21 are rejected for depending on Claim 1.
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 1, 3-12, and 21 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.
Regarding Claim 1, the claim has been amended to recite “a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen, wherein the polymeric tube defining defines a second lumen and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body”. However, neither the Specification nor Drawings describe, “a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen” and “wherein the polymeric tube defining defines a second lumen and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body”. It is unclear and therefore indefinite as to how this would be structurally accomplished, since this would encompass wherein the polymeric tube length is longer than the first lumen of the lead body (i.e., a polymer tube that extends only a portion of a length of a first lumen, but also extends from a proximal end to the distal end of the lead body). It appears that structurally, this limitation would have to specify that the first lumen must extend the entire length of the lead body. This is further evidenced by Claim 3, which states “wherein the polymeric tube extends from a proximal tip to a distal tip of the lead body”.
Appropriate correction of clarification is required. Claims 3-12 and 21 are rejected for depending on Claim 1.
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 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US Publication No. 2020/0338354, previously cited) in view of Linker et al. (US Publication No. 2010/0179562, previously cited), further in view of Kramer et al. (US Publication No. 2021/0045644).
Regarding Claims 1 and 4, Bolea et al. discloses an implantable medical lead (110, Fig. 2A), comprising: a lead body (112, Fig. 2A; Paragraph 0029) defining a first lumen (lumen of lead body 112, Fig. 8AA; Paragraph 0006, 0029, 0081-0084; Abstract),
the lead body comprising a first material (112, Fig. 2A; e.g. material suitable for implantation, Paragraph 0029);
a polymeric tube (stylet tube 705, Figs. 7AA, 8AA, 8BB; Paragraph 0081-0084) that is located within the first lumen for at least a portion of a length of the first lumen, wherein the polymeric tube defines a second lumen (stylet tube 705, Figs. 7AA, 8AA, 8BB; Paragraph 0081-0084, 0004), and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body (stylet tube 705 extending, Figs. 7AA, 8AA, 8BB; Paragraph 0081-0084), wherein the polymeric tube comprises a second material that extends along the polymeric tube length (biocompatible non-conductor such as polyurethane, Paragraph 0081);
at least one proximal connector (208, 210, 212, Fig. 2A) located on the proximal end of the lead body where the polymeric tube is present (stylet tube 705 and lead body 112 extends proximally, Figs. 2A, 7AA, 8AA, 8BB; Paragraph 0081-0084);
at least one distal electrode (114, 116, 118, Figs. 2A) located on the distal end of the lead body where the polymeric tube is present (stylet tube 705 and lead body 112 extends distally, Figs. 2A, 7AA, 8AA, 8BB; Paragraph 0081-0084);
and at least one conductor (conductors 308, Figs. 7AA, 8AA, 8BB) interconnecting the at least one proximal connector (114, 116, 118, Figs. 2A) and the at least one distal electrode (114, 116, 118, Figs. 2A).
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Although Bolea et al. discloses wherein the polymeric tube (stylet tube 705, Figs. 7AA, 8AA; Paragraph 0081-0084) comprises a second material (biocompatible non-conductor such as polyurethane, Paragraph 0081), Bolea et al. doesn’t explicitly disclose wherein the tube comprises a material comprising at least one of polyimide, acrylonitrile butadiene styrene, polyvinylidene fluoride, polycarbonate, polyethylene terephthalate, cellulose acetate, or polyvinyl chloride. However, Linker et al. teaches an implantable medical lead (lead 100, Fig. 24A-B; Paragraph 0095-0097) comprising proximal connectors (180, Figs. 24A) and distal electrodes (102, Fig. 24A), and wherein the lead further comprises a polymeric tube (stylet tube 174, Figs. 24A-B) that is located within the first lumen of the lead (lead 100, Fig. 24A-B; Paragraph 0095-0097), wherein the polymeric tube comprises a second material comprising polyimide (Paragraph 0026, 0097, 0101), polytetrafluoroethylene (Teflon/PTFE, Paragraph 0097, 0101), polyethylene terephthalate (PET, Paragraph 0100), parylene (Paragraph 0101), polyetheretherketone (PEEK, Paragraph 0099), and/or nitinol (Paragraph 0100). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to fabricate the polymeric tube in the implantable lead disclosed by Bolea et al. out of alternative materials such as polyimide, polytetrafluoroethylene, polyethylene terephthalate, parylene, and/or nitinol, as taught by Linker et al., in order to enable “high strength, tough and smooth, stylets 124 having highly radiused bends are easier to introduce and manipulate therein without the stylet 124 catching, hanging, jamming or piercing into or through the sides of the stylet tube 174 as may occur with some polymers” (Paragraph 0097, Linker et al.) and the specific material of the polymeric tube “allows the stylet lumen walls to be very thin, such as approximately 0.001 inches or less, which helps to minimizes the overall diameter of the lead 100. Such thinness may not be achieved with the use of some other biocompatible polymer materials with equivalent strength and resistance to buckling” (Paragraph 0098, Linker et al.), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Bolea et al. further discloses wherein the polymeric tube (stylet tube 705, Figs. 7AA, 8AA, 8BB; Paragraph 0081-0084) comprises a second material (biocompatible non-conductor such as polyurethane, Paragraph 0081) and the lead body comprising a first material (112, Fig. 2A; e.g. material suitable for implantation, Paragraph 0029), and that parts of the polymeric tube structure may comprise a material which has a durometer rating higher than 60 on the Shore D hardness test (band 306, which is part of stylet tube 705 comprises polyurethane having a Shore hardness of 75D, see Figs. 7AA, 8AA, 8BB; Paragraph 0047). Furthermore, Linker et al. teaches an implantable medical lead (lead 100, Fig. 24A-B; Paragraph 0095-0097) comprising polymers such as urethane or silicone (Paragraph 0095), and wherein the lead further comprises a polymeric tube (stylet tube 174, Figs. 24A-B) that is located within the first lumen of the lead (lead 100, Fig. 24A-B; Paragraph 0095-0097), wherein the polymeric tube comprises a second material comprising polyimide (Paragraph 0026, 0097, 0101), polytetrafluoroethylene (Teflon/PTFE, Paragraph 0097, 0101), polyethylene terephthalate (PET, Paragraph 0100), parylene (Paragraph 0101), polyetheretherketone (PEEK, Paragraph 0099), and/or nitinol (Paragraph 0100), and the material of the polymeric tube is “high strength, tough and smooth” and thus “stylets 124 having highly radiused bends are easier to introduce and manipulate therein without the stylet 124 catching, hanging, jamming or piercing into or through the sides of the stylet tube 174 as may occur with some polymers” (Paragraph 0097, Linker et al.) and the specific material of the polymeric tube “allows the stylet lumen walls to be very thin, such as approximately 0.001 inches or less, which helps to minimizes the overall diameter of the lead 100. Such thinness may not be achieved with the use of some other biocompatible polymer materials with equivalent strength and resistance to buckling” (Paragraph 0098, Linker et al.).
However, neither Bolea et al. nor Linker et al. explicitly discloses wherein the second material of the tube having a higher durometer rating than the first material, wherein the second material has a durometer rating higher than 60 on the Shore D hardness test.
Kramer teaches a medical lead system (Paragraph 0007-0008) comprising a proximal connector (115 connects to 100, Fig. 4; Paragraph 0048-0049) and distal electrodes (310 and 312 on distal end 120, Fig. 4, 7A; Paragraph 0050), and a body (102, 117, Fig. 4; Paragraph 0048) comprising layers, wherein an inner layer comprises a material with a Shore D hardness of about 60 to 100 (Paragraph 0048; Claims 9-10), wherein inner layers may have a hardness greater than the outer layers (Paragraph 0048, 0085-0089, 0101-0110, Claims 1, 6-9).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a second material of the tube to have a higher durometer rating than the first material, specifically wherein the second material has a durometer rating higher than 60 on the Shore D hardness test, as taught by Kramer et al., in order to enable “high strength, tough and smooth, stylets 124 having highly radiused bends are easier to introduce and manipulate therein without the stylet 124 catching, hanging, jamming or piercing into or through the sides of the stylet tube 174 as may occur with some polymers” (Paragraph 0097, Linker et al.) and the specific material of the polymeric tube “allows the stylet lumen walls to be very thin, such as approximately 0.001 inches or less, which helps to minimizes the overall diameter of the lead 100. Such thinness may not be achieved with the use of some other biocompatible polymer materials with equivalent strength and resistance to buckling” (Paragraph 0098, Linker et al.), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 3, Bolea et al. discloses an implantable medical lead further wherein the polymeric tube (stylet tube 705, Figs. 7AA, 8AA, 8BB; Paragraph 0081-0084) extends from a proximal tip to a distal tip of the lead body (stylet tube 705 and lead body 112 extends proximally and distally, Figs. 2A, 7AA, 8AA, 8BB; Paragraph 0081-0084).
Regarding Claim 5, Bolea et al. discloses an implantable medical lead further comprising a first backfill material within the first lumen and adjacent the polymeric tube (reflowed backfilled material, Paragraph 0041, 0063, 0065, 0069, 0083-0084).
Regarding Claim 6, Bolea et al. discloses an implantable medical lead further wherein the at least one conductor (conductors 308 pass through reflow material, see Figs. 7AA, 8AA, 8BB) passes through the first backfill material (reflowed backfilled material, Paragraph 0041, 0063, 0065, 0069, 0083-0084).
Regarding Claim 7, Bolea et al. discloses an implantable medical lead further wherein the first backfill material (reflowed backfilled material, Paragraph 0041, 0063, 0065, 0069, 0083-0084) extends until reaching a point along the lead body that is proximal of the at least one distal electrode (114, 116, 118, Figs. 2A) where the lead body contacts a complete circumference of the polymeric tube (reflow material only present in one section of the lead body, with sections of stylet tube 705 extending proximally/distally, see Figs. 7AA, 8AA, 8BB; Paragraph 0041, 0063, 0065, 0069, 0083-0084).
Regarding Claim 8, Bolea et al. discloses an implantable medical lead further wherein the first backfill material has a third durometer rating lower than 100 on the Shore A hardness scale (reflowed material has durometer Shore harness of 80A, Paragraph 0041, 0063; Claim 6, 16).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US Publication No. 2020/0338354, previously cited) in view of Linker et al. (US Publication No. 2010/0179562, previously cited), further in view of Kramer et al. (US Publication No. 2021/0045644), further in view of Au (US Publication No. 2022/0355102, previously cited).
Regarding Claim 9, Bolea et al. further discloses the implantable medical lead wherein the polymeric tube (stylet tube 705, Figs. 7AA, 8AA; Paragraph 0081-0084) comprises a second material (biocompatible non-conductor such as polyurethane, Paragraph 0081), further comprising a first backfill material within the first lumen and adjacent the tube (reflowed backfilled material, Paragraph 0041, 0063, 0065, 0069, 0083-0084).
However, Bolea et al., Linker et al., nor Kramer et al. in combination explicitly discloses a second backfill material within the first lumen and surrounding the first backfill material, the first backfill material having a third durometer rating lower than a fourth durometer rating of the second backfill material. Au teaches an implantable electrode assembly (Paragraph 0008, 0016) comprising a first backfill material (26, Figs. 1A, 1B, 2) and second backfill material (layers 22 and 28, Figs. 1A, 1B, 2) within a first lumen (lumen of implant 10, see Fig. 1A, Paragraph 0022-0023), and wherein the second backfill material surrounds the first backfill material (layers 28/22 surround material 26, Fig. 1B, 2; Paragraph 0022-0027), and wherein the first backfill material (26, Figs. 1A, 1B, 2; Paragraph 0023-0026) having a softer/lower durometer rating than the second backfill material (“the backfill 26 may comprise a softer (or less stiff) material compared to the first layer 22 and the second layer 28. In one example, the hardness of the first layer 22 and the second layer 28 may be around 50 Shores A-90 Shores A… and the hardness of the backfill 26 may be ≥30 Shores A, favourably ≥25 Shores A…(e.g. measured using a shore durometer)”, Paragraph 0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a second backfill material within the first lumen and surrounding the first backfill material, the first backfill material having a third durometer rating lower than a fourth durometer rating of the second backfill material, as taught by Au, in the implantable lead disclosed by Bolea et al., Linker et al., and Kramer et al. in combination, in order to effectively seal the components (see Paragraph 0023, Au) and “so that it is more difficult for the metal electrode to tear through the first layer and potential cut into the [tissue] to which the…device is being applied. The second layer may then be of a different material with different stiffness or the same material (silicone) with lower durometer configured to elicit more favorable tissue reaction or to help the.. device form factor be more pliable, which may be beneficial for lowering the pressure exerted on the [tissue], and thereby reduce the risk of mechanically induced tissue damage” (Paragraph 0025), as also taught by Au.
Allowable Subject Matter
Claims 10, 11, 12, and 21 would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims (note that this includes Claims 9, 5, and 1), and if the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) are overcome. None of Bolea et al., Linker et al., Kramer et al., nor Au explicitly discloses or suggests a first and second backfill material extending in the explicitly claimed sections of the lead body such that “the lead body contacts a complete circumference of the polymeric tube” as claimed, nor do these references disclose “wherein a center of the second lumen of the polymeric tube is offset relative to a center of the first lumen of the lead body”.
It is noted that the claims have been interpreted as described in the 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejection sections above.
Response to Arguments
The previous 35 U.S.C. 112(b) rejections of Claims 4 and 12 have been withdrawn due to the amendments to the claims as filed in the Amendment filed 14 October 2025. However, new rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) have been made above necessitated by the amendments to Claim 1.
The Applicant’s arguments filed in the Remarks filed 14 October 2025 with respect to the previous 35 U.S.C. 103 rejections of Claims 1 and 3-12 have been fully considered. The Examiner agrees that neither Bolea et al. nor Linker et al. (previously cited) explicitly discloses the newly added limitations to Claim 1, specifically, “the lead body comprising a first material; a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen, wherein the polymeric tube defining defines a second lumen and a polymeric tube length that extends from a proximal end of the lead body to a distal end of the lead body, wherein the polymeric tube comprising comprises a second material that extends along the polymeric tube length, the second material having a second durometer rating higher than 60 on a Shore D hardness test, and wherein the second durometer rating of the second material is higher durometer rating than a first durometer rating of the first material”, as recited in Claim 1 as amended. See Pages 7-10 of Remarks.
However, new 35 U.S.C. 103 rejections have been made above with the addition of the newly cited Kramer et al. reference. The Examiner agrees that neither Bolea et al. nor Linker et al. explicitly discloses wherein the second material of the tube having a higher durometer rating than the first material, wherein the second material has a durometer rating higher than 60 on the Shore D hardness test.
Newly cited Kramer teaches a medical lead system (Paragraph 0007-0008) comprising a proximal connector (115 connects to 100, Fig. 4; Paragraph 0048-0049) and distal electrodes (310 and 312 on distal end 120, Fig. 4, 7A; Paragraph 0050), and a body (102, 117, Fig. 4; Paragraph 0048) comprising layers, wherein an inner layer comprises a material with a Shore D hardness of about 60 to 100 (Paragraph 0048; Claims 9-10), wherein inner layers may have a hardness greater than the outer layers (Paragraph 0048, 0085-0089, 0101-0110, Claims 1, 6-9).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a second material of the tube to have a higher durometer rating than the first material, specifically wherein the second material has a durometer rating higher than 60 on the Shore D hardness test, as taught by Kramer et al., in order to enable “high strength, tough and smooth, stylets 124 having highly radiused bends are easier to introduce and manipulate therein without the stylet 124 catching, hanging, jamming or piercing into or through the sides of the stylet tube 174 as may occur with some polymers” (Paragraph 0097, Linker et al.) and the specific material of the polymeric tube “allows the stylet lumen walls to be very thin, such as approximately 0.001 inches or less, which helps to minimizes the overall diameter of the lead 100. Such thinness may not be achieved with the use of some other biocompatible polymer materials with equivalent strength and resistance to buckling” (Paragraph 0098, Linker et al.), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Therefore, Claim 1 is rejected as described above.
Claims 10, 11, 12, and 21 would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims (note that this includes Claims 9, 5, and 1), and if the rejections under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) are overcome. None of Bolea et al., Linker et al., Kramer et al., nor Au explicitly discloses or suggests a first and second backfill material extending in the explicitly claimed sections of the lead body such that “the lead body contacts a complete circumference of the polymeric tube” as claimed, nor do these references disclose “wherein a center of the second lumen of the polymeric tube is offset relative to a center of the first lumen of the lead body”.
It is noted that the claims have been interpreted as described in the 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejection sections above.
Therefore, Claims 1, 3-12, and 21 are rejected as described in detail above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796